eChapters

Abstract

Ladakh, a geographically isolated region, is known for its tough terrain and harsh climatic conditions. It remains cut off from rest of the country for 6-7 months in a year during winters. With limited food, fuel and other resources the people here have developed and sustained a long unique relationship with plants. They have been using both cultivated and wild ones as medicine, food, and fodder since centuries. The local populace possesses good knowledge of traditional methods of utilization of plant resources for diverse purposes, which they have acquired from their ancestors. However, this indigenous knowledge and age old practices are fast disappearing from the tribal communities, and there is an urgent need to save this treasure from getting irretrievably lost. Therefore, the present study is an attempt to document the various wild and cultivated plants along with their ethnobotanical uses as per the ancient practices of these tribal communities. For this purpose, an ethnobotanical survey was conducted in various villages of lower Ladakh. The investigation revealed a host of plants put to use by the natives in different indigenous ways. The scientific, family and local names of 50 species belonging to 48 genera and 31 families along with their uses have been enlisted in the present communication. As per the information gathered from the local inhabitants, these plants are categorized into five different groups. More than 50% of these are used as medicines, 38% are edible, 24% as fuel and 20% as fodder. Approximately 38% plants are employed in construction, as ornamentals, or sources of dyes, incense, cosmetics, etc.

Abstract

India harbors a wide variety of medicinal plants used traditionally in various remedies to treat livestock ailments. The therapeutic value of these plants attributes due to the concentration of several bioactive compounds present in them. Indigenous tribal communities are the treasurer of age-old traditional knowledge which inhabits Asian country since centuries. District Poonch exhibits a rich repository of traditional knowledge as major part of the population comprised of nomadic tribes such as Gujjars and Bakerwals which are still practicing the primitive traditional ways to treat diseases. In the present investigation, the traditional herbal plants and associated remedies for treatment of various veterinary disorders are presented. A total of 34 plant species belonging to 30 genera and 21 families have been reported which are being used by indigenous people for ethnoveterinary purposes. The majority of ethnoveterinary plants recorded from the district belong to families such as Ranunculaceae and Araceae (4 species each), Acoraceae, Amaryllidaceae, Apiaceae, Fagaceae, Lamiaceae, Primulaceae, Rutaceae (2 species each) and rest of the families members were represented by one species each. The frequently used plant parts are roots (30.23%), followed by tubers (18.6%), leaves (16.28%), fruits and whole plant (13.95% each), stems (4.65%) and seeds (2.33%). It has been observed that numerous formulations are made from these parts which are used for the treatment of various cattle infections such as abdominal colic, allergic infection, anestrous, chest diseases, constipation, cough, digestive troubles, FMD, fracture, galactagogue, gaseous bloat, induce puberty, internal injury, lung disease, pneumonia, quick discharge, removal of Leech, sexual stimulant, skin infection, snake-bite, stomachache and weakness with snake bite being dominant. The present study infers that the documentation of ethnoveterinary knowledge from the district requires utmost attention and may give leads or serves for further biochemical studies for the discovery of novel plant based drugs which will certainly helps in commercialization and betterment of tribals through benefit resource sharing.

Abstract

For thousands of years, plants have provided medicine to human and animals. People still depend on plants for food and shelter. The present surveys and investigation covers Jasrota Wildlife Sanctuary, Kathua District (J&K) situated in Southeastern parts of Asia (India). This communication mainly focused on ten high value plant species belonging to eight families of medicinal value being used to cure different types of ailment growing in Jasrota Wildlife Sanctuary and surrounding areas of Kathua district. These species are Aerva sanguinolenta (L.) Blume, Centella asiatica L. (Urb.) Fl., Cissampelos pareira L., Colebrookea oppositifolia Sm., Cryptolepis dubia M.R.Almeida, Holarrhena pubescens Wall. ex G.Don, Justicia adhatoda L., Tinospora cordifolia (Willd.) Miers ex Hook.f. & Thomson, Vitex negundo L. and Woodfordia fruticosa (L.) Kurz. It also deal with morphological enumeration, ecology and habitat, ethnobotanical uses and active chemical constituent present in studied plant species.

Abstract

Wild plants have a great role in the lives of tribal peoples living in and around the world by way of providing products for both food and medicine. Such herbal plants are the core of research, which can solve several health issues as well as nutritional supplements. Keeping on the view we have presented a summary of medicinal plants used as nutraceuticals collected from various regions of India. This communication describes 35 herbal plants used as a medicine against different diseases as well as their nutritional applicability.

Abstract

The percentage of people with obesity and diabetes has increased globally both in developed and developing countries but highest burden is on the indigenous people who are also socially disadvantaged. The modern medical treatment of diabetes is based generally on oral hypoglycaemic agents and insulin. So, there has always been a search for new anti-diabetic agents which are of lower cost and can cure the disease without harming other body functions. Plants being readily available in the Indian-subcontinent have been an important source of drug in the traditional system of medicine in India since time immemorial. The utilization of plants for alternative treatment to combat diabetes using herbal remedies has also been substantiated by World Health Organization. In this communication, we tried to list some scientifically proven anti-diabetic plants commonly available in the Indian subcontinent which can be used in the treatment and management of diabetes.

Abstract

Blumea lacera (Burm f.) DC. belonging to family Asteraceae is an annual herb with a strong odour. This herb is distributed throughout the plains of North-west India upto an elevation of 2,900 m and is also reported from Tropical Africa, South East Asia, Bangladesh, Nepal, Indonesia, Malaysia, Philippines, Thailand and Vietnam. Blumea lacera is a plant with camphor-like odour, and is highly variable, grows in grassland, field, roadside and forest edge. Traditionally, it is used internally and externally as a hemostatic and anti-inflammatory agent. The juice of leaves along with black pepper (Piper nigrum) is given to cure bleeding piles. This herb is also offered as anthelmintic (especially for threadworm). Leaves and roots are used as astringent, diuretic and febrifuge and even in cuts and wounds. Bruises and ulcers can also be treated by applying fresh juice or extract. For treating piles (Hemorrhoids), the leaves of B. lacera has been used in ethnomedicinal practices.The phytoconstituents present in leaves are mainly terpenoids, glycosides, volatile oils, some glycoalkaloids and many more yet to be determined. B. lacera has been used as an ingredient in many pharmaceutical preparations. The chapter gives a brief idea about the ethnomedicinal usage, phytochemical profile, pharmacological usage and the future perspective of B. lacera. and would help the researchers for better understanding of this plant as well as developing plant derived molecules in drug discovery process.

Abstract

Recently there has been increasing interest in plants and plant-derived compounds as medicinal agents. In Ayurveda, a wide range of medicinal uses of Pterocarpus santalinus is described. Many important bioactive phytocompounds have been extracted and identified from the heartwood of P. santalinus. The major bioactive compounds present in the heartwood of P. santalinus are santalin A and B, savinin, calocedrin, pterolinus (K,L) and pterostilbenes. These phyto-compounds present only in small amounts and have more effect than nutrients. The heartwood of the plant is used traditionally for the treatment of inflammation, diabetes, headache, skin diseases, jaundice, and in wound-healing. A wide range of pharmacological activities and health benefits of P. santalinus have been reported, including antioxidative, antidiabetic, antimicrobial, anticancer, and anti-inflammatory properties, and protective effects on liver, gastric mucosa and nervous system. All these protective effects were attributed to bioactive compounds present in P. santalinus. Most of the secondary metabolites reported from this plant are terpenes, phenolics, flavones and sterols. The present communication gives the phytochemistry and pharmacological activities of P. santalinus on health with up-to-date information.

Abstract

Plants have been used both in the prevention and cure of various diseases throughout the centuries. An important prerequisite for proper utilization of plants as natural resources is that we should have full knowledge regarding their occurrence, frequency, distribution and phenology. Arisaema jacquemontii Blume (Araceae) is a perennial herb that has been reported in various literatures to be used traditionally in various countries for the treatment of different diseases. Scientific evaluations of this plant have revealed that it harbors various phytoconstituents like alkaloids, phenols, terpenoids, flavonoids, glycosides, tannins and several other chemical constituents which have pharmacological implications with as antioxidant, antifungal, antibacterial, anticancer and immunomodulatory activities. This chapter collaborates the data with respect to the ethnobotanical and ethno medicinal importance of Arisaema jacquemontii and its role as a natural source of phytoconstituents that have therapeutic implications.

Abstract

India is known as hub of medicinal plants in recent years due to availability of variety of species in different regions which is used in treatment of frequently occurred local diseases. Family a pocynaceae is one of frequently used angiosperm members as medicine in different Indian system of medicine. At present, the genus Rauvolfia is represented by 77 species distributed across the globe, known to contains various unique active phytochemicals in the form of flavonoids, phytosterols, oleoresins, steroids, tannins and alkaloids. R. serpentina (also known as Indian snake root or sarpaghandha) and R. tetraphylla (also known as devil root or barachandrika) are two very important distinctive medicinal shrubs growing in India having wide application in traditional system of medicine for curing human disease and various herbal formulations available in market using these plants. In the present communication, we have discussed the biology, chemistry, pharmacology, cultivation practices and future perspectives of R. serpentina and R. tetraphylla for conservation and as a potential plants for future application in herbal medicine discovery.

Abstract

Natural plant products are known to prevent several deleterious diseases. This potency of plants to act as medicinal therapeutic source is due to the presence of various bioactive compounds including alkaloids, phenols, flavonoids and glucosinolates (GSLs). Among array of these compounds, GSLs are important class of plant secondary metabolites. The mechanical or physical injury to plant leads to the activation of this “GSL-myrosinase” system resulting in the formation bioactive compounds viz., thiocyanates, nitriles, isothiocyanates, and epithionitriles. Out of these compounds, isothiocyanates (ITCs) are well known for their therapeutic properties. Allyl isothiocyanate (AITC) commonly known as “mustard oil” is one of the naturally occurring ITC which is derived from hydrolysis of sinigrin, the major GSL in cruciferous vegetables like horseradish, wasabi, brussels radish etc. Due to high bioavailability in human body, it has been widely studied for its important bioactivities. Therefore, this review highlights the significant biomodulatory effects viz., antioxidant, antimutagenic, in vitro, in vivo anticancer, antimicrobial, and insecticidal activities of AITC.

Abstract

Medicinal plants are being widely used either as single drug or in combination in health care delivery system. Hemidesmus indicus is a rare and endangered plant of Deccan plateau of India and is a potential source of several active principles of therapeutic value. Its immense medicinal values can bring H. indicus as a royal source of herbal medicine in India. It contains various phytoconstituents belonging to the category glycosides, flavonoids, tannins, sterols and volatile oils. The main pharmacological activity of H. indicus include anti-inflammatory, anti-oxidants, anti cancerous activity, anti acne activity, anti venom activity, antinociceptive, renoprotective, heptoprotective activity, anti arthritis and anti leprotic activity. The root of Hemidesmus indicus was used mainly for the preparation of drink locally called as nannari or sugandhapala. The drink is medicinal, which cools the system, gives good appetite and acts as a blood purifier and roots are used for preparation of chutneys and pickles.

Abstract

Andrographis paniculata (Burm.f) Nees (Family: Acanthaceae) is one of the most popular and valuable medicinal plants with high trade value. It is out mentioned in various systems of medicine since ancient times in Indian, Malay, Chinese and Thai. Andrographis paniculata is native to Southeast Asian countries i.e., India, China, Taiwan and Sri Lanka. In India it is distributed from Uttar Pradesh, West Bengal, Assam to Mizoram and also cultivated throughout the country. The plant being used as Ayurvedic medicine in various diseases. The principal chemical constituents are lactones, diterpenoid and flavonoids. Andrographolide, neoandrographolide are the principle secondary metabolites of Andrographis paniculata with more than 80 compounds reported till now. Modern studies revealed that Andrographis paniculata has an extensive range of pharmacological activities such as hepatoprotective, anti-inflammatory, antimalarial, antimicrobial, antidiarrhoeal, anti-human immunodeficiency virus (HIV), anti-oxidant and anti-pyretic. Therefore, such plants need value addition for product development.

Abstract

Lianas are slightly lesser known angiosperms, grows typically in the form of climbing vines mostly in tropical and subtropical forests. Such plants are characterized by scandent thick stems, woody stem in nature and vary in shape and size. They depend on supports in the form of trees, fence and usually climb upward towards the sunlight as they needed for their survival. Keeping the importance of lianas in forests and household, this study was conducted to document the liana angiosperms growing in Western Himalaya along with their medicinal potential for human and animals. This study reveals a total 64 lianas species belonging to 24 families recorded from Jammu and Kashmir, Ladakh, Uttarakhand, Himachal Pradesh and Punjab. This investigation also provided with medicinal potential of these species, which is used as ethnomedicine by local people living in the interior regions of hills and mountains of Himalaya. In this communication, we highlight lianas as an example of an underestimated forest element that, on the one hand, is a key component in and around forests. This study also helps in conservation of endangered liana species in Himalaya.

Abstract

Medicinal plants in recent years attracted much attention of researchers and become the basis of modern pharmaceuticals because of their active biologically compounds. Boerhavia diffusa commonly known as Punarnava belongs to family Nyctaginaceae is a widely distributed herb that has been naturalized in many areas of the world. It is utilized as a green leafy vegetable in many Asian and African countries besides possessing anticancer, antiestrogenic, immunomodulatory and antiamoebic activities due to the presence of valuable phytochemical compounds. Medicinal value of this plant is because of presence of specific kind of phytoconstituents like alkaloids, flavonoids, triterpenoids, lipids, steroids, lignins, proteins, boeravinone A-F, glycoproteins and carbohydrates which are present in huge quantity in this herb. In view of its therapeutic importance, it is widely used in Ayurvedic, Siddha, Homoeopathy, Unani, Modern and Tribal medicinal system. Whole plant sometime its parts are utilized for curing different disorders by tribal people in India. It is a well known ethnomedicinal plant species mostly found in subtropical and tropical regions of the world.

Abstract

Demand for horticultural commodities is increasing over a period of time. There is increasing pressure on available land for growing of such crops. The production of quality fruits, vegetables and other horticultural crops can be enhanced either by increasing productivity, use of improved cultivars/hybrids and effective production system, bringing additional land under horticultural crops or by promotion of protected cultivation which supports production in adverse climatic conditions and off seasons. Among horticultural crops, production of vegetables, flowers, medicinal and aromatic plants under protected condition is the best alternative to use the land and other resources more efficiently. Greenhouse cultivation is useful and is in practice in all kinds of climatic conditions, may it be severe and extreme cold (Canada and Russia), intolerant summer (Israel, UAE and Kuwait), excessive rains (Phillippines) and in moderate climate in several other countries. Nursery production of crops under protected conditions is highly economically viable.

The area under protected cultivation was only 0.23 per cent of the total area under horticultural crops in India in 2012. To boost up this, a number of varieties are bred for cultivation especially under polyhouse conditions. Greenhouse for vegetable production encompasses glasshouse, polyhouse, insect-proof net house, low tunnel polyhouse and zero energy polyhouse. Protected structures are of different kinds, viz. open-ventilated; closed polyhouse with fan and pad system; shade net house; sloped roof, rain shelter etc. Micro-irrigation has proved its efficacy in saving water, improving the yield and also is responsible for reducing diseases which develop in rather moist conditions. Protected structures appeared as the best means and are being used by many nursery growers for multiplication of healthy planting materials and are becoming popular especially in the hilly regions. Use of techniques like soilless culture, production of high value and low volume flowers and vegetables, hybrid seed of important vegetable crops and grafting of promising varieties on desirable root stocks can be made more efficiently under protected environment. Seed yield of many crops can be 3-4 times more under cover compared to their open field cultivation along with ensured quality.

Protected cultivation technologies in Himalayan high altitudes of India for the welfare of the soldiers and the society are a landmark in cultivation of horticultural crops in non-conventional areas. The protected production system has the potential to contribute greatly for achieving high productivity and stability to production in the present scenario of climate change. Extension of growing/harvesting period including off season is another desirable feature associated with protected cultivation.

Abstract

Limits to crop production are shrinking land area under cropping, shortage and higher cost of irrigation water, fertilizers, pesticides, electricity, labour wages and harvest and post harvest losses due to non-availability of cold chains and storage spaces. Diversification of crops to high value products is yet to gain momentum. Restrictions in marketing due to APMC acts are to be reviewed and drafted farmer-producer friendly. Forcing of horticultural crops-vegetables, fruits, flowers, spices, aromatic crops-to market fresh produces during off season is getting attention and many such units are established as a part of urban and peri-urban horticulture. Ready to assemble forcing structures are now available. Hi-tech nurseries, integrated soil and water management through fertigation, pests and disease management by bio-pesticides, predators and parasitoids, pheromones and light traps are successfully demonstrated. Space saving horticulture focuses on maximization of productivity and minimization of inputs costs in an eco-friendly and sustainable way.

Abstract

Indian Horticultural produce to become competitive both in domestic and international markets, there is an urgent need for use of Hi-tech horticultural technologies. The techniques covered under Hi-tech Horticulture are genetically modified horticulture crop varieties derived from biotechnology and genetic engineering, micro-propagation, protected cultivation, micro irrigation and fertigation, high density planting, organic farming, integrated nutrient, pest and disease management and post harvest management.

Micropropagation or tissue culture technology is based on the principle of totipotency. It provides disease free, uniform sized and year round production of mass multiplication of plants in various stages viz. establishment and stablillization, shoot multiplication, pre-transplant and in vitro rooting and transplanting acclimation and ex vitro rooting. Protected cultivation is the technique of providing to the crop to protect plants from the adverse climate conditions by providing optimum growth and development conditions. High value horticulture crops mainly cut flowers and vegetables are more popular for cultivation in green houses. Greenhouse may be of different types depending on the structural designs followed as quonset, curved roof or gable roof and covering materials used as glass, acrylic, polycarbonate, fiberglass reinforced plastic panels or polyethylene etc. applicators. Micro-irrigation system is used for frequent application of required and measured quantity of water directly above or below soil surface, usually as discrete

drops, continuous drops, tiny streams or miniature spray through emitters or applicators placed along a water delivery line (laterals). It may be in form of drip irrigation, bubbler irrigation, micro jet irrigation, sprinkler, micro-sprinkler or misting (fogger) irrigation system. Similarly under fertigation system, special fertilizers in form of liquid or water soluble solids are available through a suitable irrigation system for accuracy of water application.

Abstract

High Tech interventions begin with acute desire and demand for high productivity and profit from Agricultural activity. High Tech cultivation implies judicious use of space, time and inputs; nothing more and nothing less. It is interesting to note that the different components that were listed in each case above are known to scientists and extension workers and to a lesser extent to farmers also. Piecing them together to formulate a practise is the novel thing. The major components of high tech cultivation assume the highest priority by virtue of the fact that the country has shortage for water and fertilizer and both are essential for any type of crops. Different components of high tech intervention can be used for growing crops, also for the growers to enhance production and quality .High tech intervention includes a number of components like- uniform virus free planting material, drip fertigation technology, assistance to post harvest management, and training and guidance to farmers, value addition opportunity, technical support to the farmers etc. These high tech interventions are introduced to other crops- a host of vegetables, fruits like Pomegranate, Cashew and Guava, and agricultural crops like, Cotton, Pulses, Sugarcane, and even cereals like, maize, wheat and rice. Another important aspect of such interventions is that only if concomitant interventions in marketing of produce are made, the whole exercise would bring profit to the farmers.

Abstract

Protected cultivation of horticultural crops especially vegetables provides the best way to increase the productivity and quality of vegetables especially during off-season, which also fetches better market price. Yield of some of the vegetables like tomato, capsicum and cucurbits can be increased manifold compared to their open field cultivation. Irrigation management is an important aspect of protected cultivation technology for improving the input use efficiency such as water and nutrients for the cultivation of crops under protected environment such as polyhouse, net house, poly tunnels and nursery production. Various other techniques such as use of mulch can be used to further enhance the water and nutrient use efficiency along with improving the quality of produce and precise resource savings. Automation further reduces the manual intervention and increases the input use efficiency.

Abstract

About 20 percent of the world’s total population is residing in the mountains and this proportion is likely to increase in the present century as environmental degradation and pollution are driving the human population for settlement in the clean and serene environment of the mountains. Himalayan region has sizeable area in countries like India, China/Tibet, Nepal, Pakistan, Afghanistan, Bhutan, etc. Remarkable progress has been made in greenhouse research and development in many countries. However, Himalayan regions which reserve unique flora and fauna have attracted little attention so far. Changing climate, fast increasing population and shrinking land and water resources are the major challenges before us to meet the food and nutritional security of the population at global level. Improvement in the production and productivity of crops are the immediate need to boost the availability of food and improve the economic conditions of the farmers.

Greenhouse technology has tremendous potential to improve production and productivity of crops even under uncongenial soil and climatic conditions. The farmers having very small farm holdings in countries like Japan and South Korea have improved their income and living standards by adopting protected cultivation technologies. Similarly, Israel has demonstrated successful crop production under desert and uncongenial climatic conditions by improved water management practices and using greenhouse technology. However, India is yet to trap the potentials of the technology. Modern greenhouses require uninterrupted huge electric power for control of environment (heating/cooling/air circulation etc), which is considered one of the major causes for global warming. High installation and running (energy) cost, high cost of production; poor government support and lack of farmer friendly /cost effective greenhouse technology are some other challenges. Appropriate modifications suiting to our requirements, as per the need of crop, climate and farmers may lead to popularization of greenhouses in the country, especially among the small and marginal farmers. Defence Research & Development Organisation (DRDO) successfully demonstrated the innovative approach to popularize low cost zero energy based solar greenhouse technology in higher Himalayan regions of the country. Such greenhouses are specifically designed using local resources and also trap natural solar radiation/ heat and maintain it for longer period. Similarly, other approaches like using mud/ unbaked bricks, double wall approach, making hot beds, blackening of walls, using water bottles, greenhouse-cum-animal shed, etc. effective to reduce the adverse effects of the environment on crops with little inputs in hilly regions. Need of the hour is to review our approach for the greenhouse technology in farmers’ prospective and device simple and cost effective innovations for fast propagation of greenhouses in the country. This will not only improve the economic status of the farmers but also provide nutritive food to their families and enhance production and productivity of various crops in the country without deteriorating the environment.

Abstract

Keeping in view the increasing demand of off-season and high value vegetables in several big cities of the country, there is an urgent need for diversification from the traditional agriculture by production of high value vegetable crops under different protected conditions for increasing their productivity and quality not only for getting high returns but in a Horti-Business / Veggie-business model. Nursery raising under protected cultivation is highly suitable for such Horti-business model or can be adopted as an agri entrepreneur business in major vegetable growing areas of the country by unemployed youths who are graduates in agriculture or post graduates in horticulture. Low cost protected technologies like plastic low tunnels or walk in tunnels, shade net houses can be used for off season vegetable cultivation for getting high returns. Similarly, insect proof net houses can be used on a large scale for safe vegetable cultivation by way of minimizing the use of pesticides in vegetable cultivation and virus free quality seed production in large number of vegetables in a horti-business model. Some of the technologies like low pressure drip irrigation and low cost nursery raising technology can also be replicated in other parts of the country even among the resource poor and tribal farmers.

Abstract

Space, water and labour have become limiting factors in vegetable production. Moreover, production of off-season vegetables during period of demand fetches better returns. Vegetable forcing for year round production has become a necessity in urban and peri-urban olericulture. With use of pesticides, fungicides, weedicides and chemical fertilizers, health hazards have become visible. Being treated as a field crop, vegetables are exposed to vagaries of weather and floods and droughts take heavy toll. Research on protected cultivation in India is limited but for attempts by private seed companies and enterprising farmers in Karnataka, Maharashtra, Haryana and Punjab. More emphasis is given to tomato, cucumber, capsicum, lettuce and beans. Breeding for varieties suited for protected cultivation is a recent innovation in public sector laboratories. Now there are parthenocarpic cucumbers, tomatoes and capsicum especially to suit protected cultivation. The first four vegetable varieties were developed and released by Uttarakhand State Varieties Release Committee for Horticultural Crops during 2011. These varieties namely Pant Polyhouse Hybrid Tomato -1 , Pant Polyhouse Tomato -2 in tomato and Pant Parthenocarpic cucumber -2 and Pant Parthenocarpic Cucumber -3 in cucumber. These varieties were delivered to ployhouse farmers cross the country.

Abstract

Vegetables are health capsules, being the chief source of vitamins and minerals besides providing other dietary elements like carbohydrates, proteins and even fat and enzymes to some extent, antioxidants and fibre. Though India is the second largest vegetable producer (147 million tones in 2012) in the world, per capita supply and consumption of vegetables in India is very low (160 g day ^-1). It is now realized that the problems of satisfying hunger and nutrition are much beyond the realm of food crops alone and therefore, to supplement and balance our diet, more vegetables are to be included. Vegetables not only provide nutritional security in rural areas but also financial security to small and marginal land holders growing vegetables in the hinterlands of urban markets. Commercialization of vegetable production is the scene of the day as they are money spinners in domestic markets and dollar earners in global markets. To compete in the domestic and global market and for year round supply of quality produce, protected or greenhouse cultivation of vegetables is imperative. Water and nutrients are the top most growth and production inputs in any crop cultivation and vegetables are no exception to this. In order to get the potential yields with matching quality of vegetables grown under protected cultivation, the best of the management strategies to supply water and nutrients is needed. In this direction, drip fertigation is the best option for efficient supply of irrigation water and fertilizer nutrients for greenhouse grown vegetable crops. The studies carried in different parts of the world have clearly indicated that fertigation technology resulted in substantial yield increase with marked enhancement of water and nutrient productivity.

Abstract

High altitudes may be cold and humid or cold or arid ones making the requirements of protected cultivation entirely different in both the conditions. The present chapter is based on the environmental conditions existing in Leh region. Near sub-zero temperature with snow in higher altitudes makes vegetable production tough without use of techniques of protected cultivation. Protected cultivation has witnessed gradual developments from riverbed cultivation practices to use of several types of plastics (PP, PE, PVC etc.) and UV stabilized polythene sheets. Area under protected cultivation is spread worldwide mainly in countries like Holland, Spain, Isaral, China , Japan etc. Protected cultivation technology provides favorable climate for production of vegetable &/or their seedlings of superior quality even in the extreme adverse climate outside. Such structure exploits solar thermal energy to improve photosynthetic efficiency of the plants grown inside. This green house effect is very helpful in winters at high altitudes. Similarly, some modifications in these structures are needed to low the temperature during summers. A number of advantages with some limitations can be listed that are associated with the protected cultivation. At high altitudes, three methods viz. Polyhouse/Greenhouse /Net /shaded house, Low tunnels or row covers and plastic mulching can be used. Polyhouse is a framed structure with 200 micron UV stabilized low density cladding forming a greenhouse effect. Underground trench type polyhouse can also be made with polyethylene supported on wooden poles or GI pipes. Though a combination of above two known as polyench was found performing better in Ladhak area. Low tunnels or row cover use transparent plastic films or net over low hoops to cover rows of plants. Mulching is covering the soil around plants to conserve soil moisture, temperature, preventing weeds etc. using transparent and black plastics of 10-25micron thickness. Double colored plastic mulches are being tested for different crops and different seasons. In arid high altitudes, DRDO (through DIHAR, Leh) has worked extensively on protected cultivation and developed production technologies in the service of nation. Its contribution includes making possible the production of nursery, cucurbits and several other vegetables and their seeds in sub zero climatic conditions. Now, there is a need to develop more area specific, more appropriate, efficient and economic protection structures. Simultaneous development of tools, machinery and vegetable varieties suitable for use in protected conditions are among the major aspects of future work to be done in this field.

Abstract

Production of healthy and vigorous seedlings is the foremost crucial step for raising a successful vegetable crop. Now a days seedlings are raised in trays under controlled atmospheric conditions called as transplants. As soil substitutes, artificial media made of perlite, vermiculite and peat moss are commercially available. A good rooting medium should be light weight, well drained, well aerated, and soilless with or without starter solution or added nutrients and with good water and nutrient holding capacity. The media should be sterilized before use. Selection of trays for cell shape, size and number depends on the type and nature of crop. Most of the vegetable transplants are now being produced in hardened plastic or polystyrene containers. Only good quality certified seeds should be used in media filled trays after priming, pelleting, coating or other seed treatments as per the crop requirement. Germination chambers as insulated rooms to maintain suitable conditions over large period of time may also be used. Generally vegetable crops need fertilizer application after expansion of first true leaf. Young seedlings are managed carefully to avoid any toxicity while taking care of their nutrient management. Water requirement also depends on growth stage and variation in weather conditions. Other seedling management practices include shading, thinning, weeding, disease/pest control, hardening off and subsequent transplanting. Containerized greenhouse plants can be grown using the conventional “rail” (or rack) system or the “float” system. Shipping factors such as mechanical injury, environmental conditions and length of storage affect plant vigour and establishments. IPM (integrated pest management) offers a practical way to effectively manage pests on vegetable bedding and transplants.

Abstract

Greenhouse vegetable cultivation is gaining popularity for reasons such as high productivity of quality produce round the year with enhanced input use efficiency. As agriculture has a major share in our economy and if India has to emerge as an economic power in the world, the productivity should substantially increase from the present levels. We need a new and effective technology which can constantly improve the productivity, profitability and sustainability of our major farming systems. One such technology is the green house vegetable production technology. At Indian Institute of Horticultural Research, Bangaluru, research on greenhouse vegetable production is in progress since the year 2000, resulting in the development of many technologies which have made possible to realize high yield levels in tomato, capsicum and cucurbits that are comparable to international standards of greenhouse productivity. Tomato and bell pepper yields have touched 300 tonnes and 200tonnes/ha/year, respectively and cucurbits 80 to 100 tonnes/ha/crop of 3 months. Vegetable cultivation in cost effective greenhouse is a technical reality in India, which is being adopted by resourceful farmers in and around big towns and cities as a peri-urban horticultural system. Such production systems have not only extended the growing season of vegetables and made their availability round the year but also opened the possibilities of growing new vegetables such as coloured capsicums, cherry tomatoes, seedless watermelons, icebox melons, sweet cucumbers, coloured cabbage, etc., besides tomato, cucumber, eggplant and climbing beans. Quality seedling production is one more important greenhouse activity in the present agricultural scenario as more and more F₁ hybrids are being adopted by the farmers.

Protected cultivation is a specialized agricultural system in which a certain control of the soil–climate ecosystem is exercised modifying its conditions (soil, temperature, solar radiation, wind, humidity and air composition). Plants are cultivated by means of these techniques modifying their natural environment to prolong the harvesting period, alter the conventional cropping cycles, increase yields, improve product quality, stabilize production and provide products when open field cultivation is limited (Wittwer and Castilla, 1995). It is the most contemporary approach to produce mainly, horticultural crops qualitatively and quantitatively and has spread extensively the world over in the last few decades. Protected cultivation also known as controlled environment agriculture (CEA) is highly productive, conservative of water and land and also protective of the environment (Jensen, 2002). Protected cultivation is now becoming popular in Kerala experiencing humid tropical climate with the adoption of locally suitable green house technologies.

Protected cultivation has rapidly expanded in many regions across the globe as early as 1960, when plastics were introduced/used in agriculture and subsequently during 1970’s, when the rise in oil prices resulted in increase of energy costs. About 115 countries in the world are into greenhouse vegetable production commercially (Sabir and Singh, 2013). The world scenario shows the area under protected cultivation to be nearly 6,23,302 ha. while total estimated world greenhouse vegetable production area is 4,02,981 ha. Of the total world greenhouse vegetable area, soilless/hydroponic culture systems account for 95,000 ha (Hickman, 2011).

The advent of protected cultivation technology in India materialized during the early nineties, post globalization. In India, area under protected cultivation is presently around 25,000 ha while the greenhouse vegetable cultivation area is about 2,000 ha. Faced with constraints of land holdings, rapid urbanization, declining crop production, declining biodiversity and ever increasing population, demand for food, especially vegetables has increased manifold and protected cultivation has offered a new dimension to produce more in a limited area. Today Dutch protected cultivation is one of the most intensive farming systems in the world with high levels of output by using the latest technologies (Goncharova, 2004).

Abstract

Protected cultivation technology in black pepper and cardamom offers distinct advantages over conventional farming. Production of quality planting materials irrespective of the season was made possible. Such propagating materials can be well maintained under polyhouse, irrespective of the seasons and can be used judiciously for replanting/ gap filling. In this era of climate change, protected cultivation assumes significance. In black pepper and cardamom, rapid multiplication techniques of planting materials were made possible. A novel idea of growing pepper, different from conventional system as “bush” that can be grown under potted and field conditions were also developed. Nutrition and water management studies could be undertaken with precision. In cardamom, quality planting material production and high quality capsule production are made possible all throughout the year by the adoption of protected cultivation. For optimizing production, prescriptions of fertilizers, using DRIS norms were developed for black pepper and cardamom based on critical soil and foliar nutrient concentrations. Typical deficiency symptoms of major and micro nutrients on black pepper were characterized to rectify the deficiency. Technology for propagation and cultivation of bush pepper in pots, under protected cultivation was also developed and popularized. Technology for using organic manures, non edible oil cakes, biofertilizers towards production of high quality zero defect black pepper and cardamom was also developed and popularized.

Abstract

Floriculture is the fast emerging sector in horticulture sector and people are changing very fast from the traditional field crops to flowers because of high returns per unit of area and better price. The flowers are being used during all the occasions. Though the art of growing flowers is not new to India, large scale commercial cultivation and protected cultivation in polyhouses is relatively new in India. With the opening up of world market in the WTO regime, there is a free movement of floriculture products worldwide. India is having a better scope in future as there is a shift in trend towards tropical flowers and this can be gainfully exploited by countries like India with high amount of diversity in indigenous flora. The major flowers grown under protected cultivation are rose, chrysanthemum, gerbera, carnation and lilium. Even some of the flowers are location specific and made a dent on the state economy, the best examples are carnation in Himachal Pradesh and gerbera in Maharashtra. Now with market trend is changing and biotechnological tools must be exploited for the crop improvement to evolve novel varieties with desirable colour traits. The other major area of work is on protected cultivation of cut flowers which is coming up on a large scale and value addition in floriculture i.e. extraction of pigments, essential oils, pharmaceutical and nutraceutical compounds have emerged as frontline avenues in floriculture. We have many challenges ahead like trained HRD, quality planting material, technical knowhow, limited choice of the varieties and products in the market to compete in global market.

Abstract

Domestic market both for cut flowers as well as loose flowers have increased significantly owing to rapid urbanization, changes in social attitude, increase in income level and the increasing habit of ‘saying it with flowers’. The per capita consumption of flowers is increasingly growing up due to which the production has been increased and non-traditional areas have emerged as important players in floricultural production. In this scenario of intensive production system, protected cultivation can be a viable option. Protected cultivation offers unique opportunities to produce high quality flowers round the year and insulate from weather vagaries thus, reduceing risk from the climatic variations. Protected structure comprises of high cost, medium cost and low cost polyhouses and each structure needs specific varieties and technologies to achieve maximum yield. Hence, breeding program should be based on structure and climate as it has been observed that varieties bred in Northern hemisphere under high cost greenhouses are not performing alike in medium and low cost polyhouses of Southern hemisphere. Breeding work in India has been carried out in wide range of floriculture crops. Breeding of many floricultural crops are in fact not always simple and straightforward due to polyploidy, complex ancestry involving one or more species, aneuploidy, and in some families self and cross sterility barriers, etc. It appears that breeders have vast opportunities to incorporate disease and insect screening and development of varieties for protected cultivation in routine breeding programs during the evaluation of seedlings. To develop varieties for such adversities, our research institutes should have enough infrastructures to carry out required research. In a few areas, protected cultivation has succeeded in India due to efforts of private companies and enterprising farmers. Recently, with greater efforts of ICAR a few public institutions have started breeding of flower varieties suited for protected cultivation.

Abstract

The tradition of growing of flowers is age old. The flowers have travelled from the bowl of prayers to gardens to commercial sector for revenue. The quality concerned world demands for round the year production and supply of quality produce which can only be possible under controlled environment production. A range of location specific and crop specific infrastructures are being commercially used for production of planting material and flowers. General and crop specific guidelines for trade of cut flowers are available which the producers and policy makers must know for successful promotion of export of cut flowers from the country. The producer can also use practical methods for vase life study of their produce which is of great relevance in cut flower trade.

Keywords: Protected floriculture, trade, crop specific guidelines, export, cut flower

Introduction

Indian floriculture industry is shifting from traditional flowers to cut flowers for export purpose. The liberalized economy has given an impetus to Indian entrepreneurs for establishing export oriented units (EOUs) under controlled climatic conditions. The wide variations in agro climatic conditions in India permit us to grow various types of tropical and subtropical flowers. Though such plants grow successfully in open conditions without cover, they fail to meet the quality requirements of being blemish free. High quality ornamental plants meant for export should be scientifically grown only in plastic, glass or fibre glass greenhouses or at least under partial cover. Though initial investment is high in protected cultivation, the products in them will obtain far more attractive prices.

Even though we are now in the atomic age, the idea of the atom is not new. More than 2,000 years ago, the Greek philosopher Democritus suggested that any matter is composed of tiny indestructible particles called Atoms. The word atom is derived from the Greek word Atoms meaning something that can not be cut further. However not much attention was paid to this concept till 1808, when Dalton proposed the famous “Atomic theory”. According to this theory, “all matter is composed of tiny indivisible particles called ‘Atom’. Combining the ideas of Lavoisier, Boyle and his own, Dalton proposed that atoms of elements combine together to make molecules of a compound. This was a great step in the concept of the atom and compounds, since this gave a clear picture of how the supposedly smallest particles of matter called atoms could be put together to form the various familiar substances found in nature.

2.1 Isotopes

In 1913, J.J. Thomson and Aston introduced atmospheric neon into the positive ray apparatus and got two parabolas corresponding to masses 20 and 22, with the intensities of the tracks corresponding to the ratio of 9:1, irrespective of the condition of discharge and pressure. This indicated that neon existed in two forms having atomic weights 20 and 22, and at the same time it could not be distinguished chemically. These two types are known as isotopes of neon (iso = same, topas = place in the periodic table). When the average atomic weight of the ordinary neon was calculated based on the abundance of these two forms in the ordinary neon, it was found to be 20.2 which agreed the chemical methods. Thus the existence of isotopes of a given element was discovered.

Formerly isotopes were defined chemical properties but with different atomic weights, the same atomic number and occupying the same position in the periodic classification. Later this definition was slightly modified and now isotopes are defined as nuclides with the same number of protons but differing in the number of neutrons, for example, ordinary hydrogen (also called protium ; proton =1 and neutron =0), deuterium (heavy hydrogen ; proton =1 and neutron = 1), and tritum super heavy hydrogen (proton =1 and neutron =2). Investigations using mass spectrographs have revealed more than 280 isotopes which are stable artificially radioactive isotopes.

Radioactivity

The discovery of radioactivity, in general, actually came about on a few different fonts. First was the discovery of x-ray radiation that was artificially generated in a laboratory, followed by the discovery of several elements that naturally emit radiation when the nucleus of the atoms disintegrates or decay. These are the elements that today are called radioactive elements and are said to have unstable nuclei.

4.1 Selection of Isotopes for Tracer Studies

In radioisotopes we have all the essentials of a powerful research tool, a non-destructive means by which atoms could be followed and detected in the organism. Application mainly depends on the fact that chemical properties of the isotope of an element are essentially identical.

The basic requirement of a tracer is that it be

1.Chemically and physically, virtually equivalent to the substance it represents or displaces and that it, in no appreciable way, affect the system differing from its normal counterpart.

2.Radioactivity could be detected directly and

3.Unaffected by the physical or chemical treatments that are given. Hence, this has been used widely in the investigations of the various problems in biology, chemistry, physics and other fields like agriculture.

Carbon dating uses the half-life of Carbon-14 to find the approximate age of an object that is 40,000 years old or younger.

5.1 What is radiocarbon dating ?

Radiocarbon dating is a method of estimating the age of organic material. It was developed right after World War II by Willard F. Libby and coworkers, and it has provided a way to determine the ages of different materials in archeology, geology, geophysics, and other branches of science. Some examples of the types of material that radiocarbon can determine the ages are wood, charcoal, marine and freshwater shell, bone and antler, and peat and organic-bearing sediments. Age determinations can also be obtained from carbonate deposits such as calcite, dissolved carbon dioxide, and carbonates in ocean, lake, and groundwater sources.

Although a number of radioactive isotopes are found in nature, most of the isotopes used as radioactive tracers are produced artificially. Methods for producing radioactive isotopes include nuclear fission and the bombardment of selected materials by neutrons or positively charged particles.

6.1 Production of Radioactive Nuclides

Nuclear Reactors

In a nuclear reactor, a fissionable nuclear fuel such as ²³⁵U or ²³⁹Pu is placed in a defined geometry within the reactor core. Fast moving neutrons released as the ²³⁵U or ²³⁹Pu nuclei fission are slowed to thermal energy (0.025 eV) by a low-Z moderator such as water, heavy water, beryllium, or graphite surrounding or mixed intimately with the nuclear fuel. The slowly moving neutrons are absorbed by addition of ²³⁵U or ²³⁹Pu nuclei, and a chain reaction is maintained. The rate of absorption of slow neutrons by fissionable nuclei determines the fission rate for the reactor and is controlled by placing inert neutron absorbers in the reactor core. Typical neutron absorbers, usually termed control roads include boron and calcium. Heat generated in the reactor is removed by a coolant such as water or one of a variety of gases or liquid materials.

7.1 Measurement of Radiation Dose

Radiation dosimetry involves the measurement of the energy actually absorbed in a substrate exposed to ionizing radiation. The radiation may be either electromagnetic or corpuscular in nature. The passage of electromagnetic radiation through a substrate causes ionization by virtue of the secondary electrons released. Particle radiations on the other hand, ionize directly because they are charged, or indirectly through the charged particle resulting from a collision with a substrate. Alpha, beta particles, and protons yield primary ionization. Gamma rays and neutrons produce ionizing radiation by their interaction with the substrate in passage through it.

Although some forms of electromagnetic energy, such as light and heat, can be detected by the human senses. One of the greatest draw backs to high energy radiation is the inability to detect it. We cannot see, feel, taste, smell, or hear the various forms of ionizing radiation. Fortunately, ionizing radiation interacts with matter which makes detection and measurement possible by utilizing specialized equipment. In this section we want to introduce you to the various ways and means of detecting and measuring ionizing radiation.

As mentioned previously, Becquerel discovered radioactivity because it left marks on photographic film as a means of detecting radiation. However, there are more definitive means commonly used by scientists and technicians who study and work with radiation. The equipment utilized for the detection and measurement of radiation commonly employs some type of a substance or material that responds to radiation. Many common methods use either an ionization process or molecular excitation process as a basis. Remember that we stated earlier that radiation interacts with matter. For detection and measurement purposes the process of ionization is the most commonly employed technique, based on the principle of charged particles producing ion pairs by direct interaction. These charged particles may collide with electrons, which remove them from their parent atoms, or transfer energy to an electron by interaction of electric fields.

9.1 Potential Tracer Difficulties and their Corrections

In radioactive measurements, the observed counting rate is not equal to the true disintegrations rate of the sample since a number of factors like nature of detectors tend to increase it or, in a majority of cases, decrease the actual counts. Some of the important factors responsible for this are

1.Background,

2.Backscattering

3.Absorption

4.Self absorption

6.Geometry

7.Instrument efficiency

Radionuclides are used in two major ways: for their chemical properties and as sources of radiation.

Radionuclides of familiar elements such as carbon can serve as tracers because they are chemically very similar to the non-radioactive nuclides, so most chemical, biological, and ecological processes treat them in a near identical way. One can then examine the result with a radiation detector, such as a Geiger counter, to determine where the provided atoms ended up. For example, one might culture plants in an environment in which the carbon dioxide contained radioactive carbon; then the parts of the plant that had laid down atmospheric carbon would be radioactive.

In medicine, radioisotopes are used for diagnosis, treatment, and research. Radioactive chemical tracers emitting gamma rays that can provide diagnostic information about a person’s internal anatomy and the functioning of specific organs. This is used in some forms of tomography single emission computed tomography and positron emission tomography scanning. Radioisotopes are also a promising method of treatment in hemopoietic forms of tumors, while the success for treatment of solid tumors has been limited so far. More powerful gamma sources are used to sterilize syringes and other medical equipment. About one in two people in Western countries are likely to experience the benefits of nuclear medicine in their lifetime.

In biochemistry and genetics, radionuclides are used to label molecules and allow tracing chemical and physiological processes occurring in living organisms, such as DNA replication or amino acid transport.

In the Radiochemical Laboratory

The following are some illustrative recommendation which may be used selected as a guide for setting up working rules :

General

No unnecessary materials should be brought into the laboratory. No unnecessary work should be done there.

Eating, drinking, and the use of cosmetics in the laboratory should be forbidden. Radioactive materials should not be place in milk bottles, soft drink bottles, or other vessels that might be inadvertently used for food purposes.

Record should be kept of radioactivity brought into the building and of its disposition.

Accuracy

The degree of closeness of the determined value to the nominal or known true value under prescribed conditions. This is sometimes termed trueness.

Analyte

A specific chemical moiety being measured, which can be intact drug, bio molecule or its derivative, metabolite, and/or degradation product in a biologic matrix.

Analytical run (or batch)

A complete set of analytical and study samples with appropriate number of standards and QCs for their validation. Several runs (or batches) may be completed in one day, or one run (or batch) may take several days to complete.

Biological matrix

A discrete material of biological origin that can be sampled and processed in a reproducible manner. Examples are blood, serum, plasma, urine, faces, saliva, sputum, and various discrete tissues.

TQM is an integrative philosophy of management for continuously improving the quality of products and processes. It is used around the world.

TQM functions on the premise that the quality of products and processes is the responsibility of everyone who is involved with the creation or consumption of the products or services offered by an organization. In other words, TQM capitalizes on the involvement of management, workforce, suppliers, and even customers, in order to meet or exceed customer expectations. Considering the practices of TQM as discussed in six empirical studies, Cua, McKone, and Schroeder (2001) identified the nine common TQM practices as cross-functional product design, process management, supplier quality management, customer involvement, information and feedback, committed leadership, strategic planning, cross-functional training, and employee involvement.

TQM and Six Sigma

The Six Sigma management strategy originated in 1986 from Motorola’s drive towards reducing defects by minimizing variation in processes. The main difference between TQM and Six Sigma is the approach Six Sigma is a business management strategy originally developed by Motorola, USA in 1986. As of 2010, it is widely used in many sectors of industry, although its use is not without controversy.

It 9001:2000 Means customer satisfaction and continuous improvement

ISO (International Organization for Standardization) is a worldwide federation of national Standards bodies from each country. The object of ISO is to promote the development of Standardization and related activities in the world with a view to facilitating international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity. The results of ISO technical work are published as International Standards.

Quality management Systems (QMS) certification as per ISO 9001 : 2000 is an important opportunity that can enable the companies acquire the label of an enterprise caring for the customer needs and improve their economic performance at the same time. QMS provides an organization a systematic structured documented and effective approach to consistently maintain the product quality meeting customer requirements.

Environmental management systems (EMSs) such as ISO 14000 are seen as mechanisms for achieving improvements in environmental performance and for supporting the trade prospects of “clean” firms. The potential advantages of EMSs are clear, but the adoption of ISO 14000 is very recent, and practical issues are emerging, among them the need for an emphasis on performance improvement and for simplification of certification; the potential for regulatory streamlining; and the trade consequences. This chapter outlines the key elements of an EMS and discusses these issues.

The Benefits of an EMS

An environmental management system (EMS) is a structured program of continuous environmental improvement that follows procedures drawn from established business management practices. The concept is straightforward, and the principles can be easily applied, given the necessary support. There has been increasing interest in the potential value of EMS approaches, ofwhich the recently released ISO 14000 series is the most widely known.

The first steps in the control of industrial pollution have been the creation of the necessary regulatory framework and the specification and design of control equipment to reduce emissions. These efforts have been broadly successful in improving the performance of many polluters, but in other cases, investments in pollution equipment are wasted because the equipment is not operated properly. Attention, in the World Bank and elsewhere, is turning to support of regulatory and end-of-pipe approaches through incentives, production efficiencies, and management improvements a range of measures often grouped under the broad banner of cleaner production and eco-efficiency.

1. GMP

Good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products

To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs and no other manufacturing activity shall be undertaken therein.

Introduction

In the 1997 WHO guidance document: “WHO/VSQ/97.01: (A WHO guide to good manufacturing practice (GMP) requirements. Part 1: Standard operating procedures and master formulae)” some basic explanations and instructions were given for preparing various documents required by Good Manufacturing Practice guidelines from WHO and from several regulatory authorities.

GMP guidelines include the requirements for documents (individual), documentation (the systems and formats for documents), and documenting (recording) of production and control activities. Most GMP guidelines provide the same or very similar information as the principles of Good Manufacturing Practice are now international in scope.

In this guidance document, the requirement for master manufacturing instructions and the requirements as given in different GMP documents, different names for these documents and various forms that they can take will be described. This is to guide vaccine manufacturers who are applying for pre-qualification or re-qualification of their product(s) in the preparation or improvement of current documents for manufacturing operations.

Principle

Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Specifications, Manufacturing Formulae and instructions, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance.

General

Specifications describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation. Manufacturing Formulae, Processing and Packaging Instructions state all the starting materials used and lay down all processing and packaging operations.

Procedures give directions for performing certain operations e.g. cleaning, clothing, environmental control, sampling, testing, and equipment operations.

Records provide a history of each batch of product, including its distribution, and also of all other relevant circumstances pertinent for the quality of the final product.

Validation in the pharmaceutical and medical device industry is defined as the documented act ofdemonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements. Since a wide variety ofprocedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following: