1

High-performance liquid chromatography chemicals from each other), and manufacturing (e.g. during the production process of pharmaceutical and biological products).[1]

Chromatography can be described as a mass transfer process involving adsorption. HPLC relies on pumps to pass a pressurized liquid and a sample mixture through a column filled with a Schematic representation of an HPLC unit. (1) sorbent, leading to the separation of the sample Solvent reservoirs, (2) Solvent degasser, (3)components. The active component of the Gradient valve, (4) Mixing vessel for delivery column, the sorbent, is typically a granular of the mobile phase, (5) High-pressure pump,material made of solid particles (e.g. silica, (6) Switching valve in "inject position", (6')polymers, etc.), 2-50 micrometers in size. The Switching valve in "load position", (7) Samplecomponents of the sample mixture are injection loop, (8) Pre-column (guard column),separated from each other due to their different (9) Analytical column, (10) Detector (i.e. IR,degrees of interaction with the sorbent particles. UV), (11) Data acquisition, (12) Waste orThe pressurized liquid is typically a mixture of solvents (e.g. water, acetonitrile and/or fraction collector. methanol) and is referred to as a "mobile High-performance liquid chromatographyphase". Its composition and temperature plays a (formerly referred to as high-pressure liquidmajor role in the separation process by chromatography), HPLC, is ainfluencing the interactions taking place chromatographic technique used to separate thebetween sample components and sorbent. These components in a mixture, to identify each interactions are physical in nature, such as component, and to quantify each component.hydrophobic (dispersive), dipole-dipole and HPLC is considered an instrumental techniqueionic, most often a combination thereof. of analytical chemistry (as opposed to a gravitimetric technique). In general, the methodHPLC is distinguished from traditional ("low involves a liquid sample being passed over apressure") liquid chromatography because solid adsorbent material packed into a columnoperational pressures are significantly higher bar), while ordinary liquid using a flow of liquid solvent. Each analyte in (50-350 the sample interacts slightly differently with the chromatography typically relies on the force of adsorbent material, thus retarding the flow ofgravity to pass the mobile phase through the the analytes. If the interaction is weak, thecolumn. Due to the small sample amount analytes flow off the column in a short amountseparated in analytical HPLC typical column of time, and if the interaction is strong, then thedimensions are 2.1 - 4.6 mm diameter, and 30 elution time is long. HPLC has been used in 250 mm length. Also HPLC columns are made medical (e.g. detecting vitamin D levels inwith smaller sorbent particles (2- 5 micrometer blood serum), legal (e.g. detecting performancein average particle size). This gives HPLC enhancement drugs in urine), research (e.g.superior resolving power when separating separating the components of a complexmixtures, which is why it is a popular biological sample, or of similar syntheticchromatographic technique.

2
The schematic of an HPLC instrumentfrom the column) is called its retention time. typically includes a sampler, pumps, and aThe retention time measured under particular detector. The sampler brings the sampleconditions is considered an identifying characteristic of a given analyte. mixture into the mobile phase stream which carries it into the column. The pumps deliver Many different types of columns are available, the desired flow and composition of the filled with sorbents varying in particle size, and in the nature of their surface ("surface mobile phase through the column. Thechemistry"). The use of smaller particle size detector generates a signal proportional topacking materials requires the use of higher the amount of sample component emergingoperational pressure ("backpressure") and from the column, hence allowing fortypically improves chromatographic resolution quantitative analysis of the sample(i.e. the degree of separation between components. A digital microprocessor andconsecutive analytes emerging from the column). In terms of surface chemistry, sorbent user software control the HPLC instrument particles may be hydrophobic or polar in nature. and provide data analysis. Some models of Common mobile phases used include any mechanical pumps in a HPLC instrument miscible combination of water with various can mix multiple solvents together in ratiosorganic solvents (the most common are changing in time, generating a compositionacetonitrile and methanol). Some HPLC gradient in the mobile phase. Varioustechniques use water-free mobile phases (see detectors are in common use, such asNormal-phase chromatography below). The UV/Vis, photodiode array (PDA) or based onaqueous component of the mobile phase may mass spectrometry. Most HPLC instrumentscontain acids (such as formic, phosphoric or trifluoroacetic acid) or salts to assist in the also have a column oven that allows for separation of the sample components. The adjusting the temperature the separation iscomposition of the mobile phase may be kept peOperation constant ("isocratic elution mode") or varied The sample mixture to be separated and("gradient elution mode") during the analyzed is introduced, in a discrete smallchromatographic analysis. Isocratic elution is volume (typically microliters), into the streamtypically effective in the separation of sample of mobile phase percolating through thecomponents that are not very dissimilar in their column. The components of the sample moveaffinity for the stationary phase. In gradient through the column at different velocities,elution the composition of the mobile phase is which are function of specific physical varied typically from low to high eluting interactions with the sorbent (also calledstrength. The eluting strength of the mobile stationary phase). The velocity of eachphase is reflected by analyte retention times component depends on its chemical nature, onwith high eluting strength producing fast the nature of the stationary phase (column) andelution (=short retention times). A typical profile in reversed phase on the composition of the mobile phase. Thegradient time at which a specific analyte elutes (emerges chromatography might start at 5% acetonitrile

3
(in water or aqueous buffer) and progressHACCP is referred as the prevention of hazards linearly to 95% acetonitrile over 525 minutes.rather than finished product inspection. The Periods of constant mobile phase compositionHACCP system can be used at all stages of a may be part of any gradient profile. Forfood chain, from food production and example, the mobile phase composition may bepreparation processes including packaging, kept constant at 5% acetonitrile for 13 min,distribution, etc. The Food and Drug followed by a linear change up to 95% Administration (FDA) and the United States acetonitrile. Department of Agriculture (USDA) say that The chosen composition of the mobile phasetheir mandatory HACCP programs for juice and (also called eluent) depends on the intensity ofmeat are an effective approach to food safety interactions between various sampleand protecting public health. Meat HACCP components ("analytes") and stationary phasesystems are regulated by the USDA, while (e.g. hydrophobic interactions in reversed-phaseseafood and juice are regulated by the FDA. HPLC). Depending on their affinity for the The use of HACCP is currently voluntary in stationary and mobile phases analytes partitionother food industries. between the two during the separation processHACCP is believed to stem from a production taking place in the column. This partitioningprocess monitoring used during World War II process is similar to that which occurs during abecause traditional "end of the pipe" testing on liquid-liquid extraction but is continuous, notartillery shell's firing mechanisms could not be step-wise. In this example, using aperformed, and a large percent of the artillery water/acetonitrile gradient, more hydrophobicshells made at the time were either duds or components will elute (come off the column)misfiring.[1] HACCP itself was conceived in the late, once the mobile phase gets more1960s when the US National Aeronautics and concentrated in acetonitrile (i.e. in a mobileSpace Administration (NASA) asked Pillsbury phase of higher eluting strength). to design and manufacture the first foods for The choice of mobile phase components,space flights. Since then, HACCP has been additives (such as salts or acids) and gradientrecognized internationally as a logical tool for conditions depend on the nature of the columnadapting traditional inspection methods to a and sample components. Often a series of trialmodern, science-based, food safety system. runs are performed with the sample in order to Based on risk-assessment, HACCP plans allow find the HPLC method which gives adequateboth industry and government to allocate their resources efficiently in establishing and separation. auditing safe food production practices. In Hazard analysis and critical control points 1994, the organization of International HACCP Hazard analysis and critical control points,Alliance was established initially for the US or HACCP is a systematic preventivemeat and poultry industries to assist them with approach to food safety and allergenic,implementing HACCP and now its membership chemical, and biological hazards in productionhas been spread over other [2] processes that can cause the finished product to professional/industrial areas. be unsafe, and designs measurements to reduce these risks to a safe level. In this manner,

4
Hence, HACCP has been increasingly appliedvery little was left for actual use. It was realized to industries other than food, such as cosmeticsthat a new approach was needed. and pharmaceuticals. This method, which inNASA's own requirements for Critical Control effect seeks to plan out unsafe practices based Points (CCP) in engineering management on science, differs from traditional "producewould be used as a guide for food safety. [4] CCP and sort" quality control methods that doderived from Failure mode and effects analysis nothing to prevent hazards from occurring and (FMEA) from NASA via the munitions industry must identify them at the end of the process. to test weapon and engineering system HACCP is focused only on the health safetyreliability.[4] Using that information, NASA and issues of a product and not the quality of the Pillsbury required contractors to identify product, yet HACCP principles are the basis of "critical failure areas" and eliminate them from most food quality and safety assurancethe system, a first in the food industry then. [4] systems,and the United States, HACCPBaumann, a microbiologist by training, was so compliance is regulated by 21 CFR part 120pleased with Pillsbury's experience in the space and 123. Similarly, FAO/WHO published aprogram that he advocated for his company to guideline for all governments to handle theadopt what would become HACCP at Pillsbury. issue in small and less developed food[4] businesses.[3] Soon thereafter, Pillsbury was confronted with History a food safety issue of its own when glass In the early 1960s, a collaborated effortcontamination was found in farina, a cereal between the Pillsbury Company, NASA, andcommonly used in infant food.[4] Baumann's the U.S. Army Laboratories began with the leadership promoted HACCP in Pillsbury for objective to provide safe food for spaceproducing commercial foods, and applied to its expeditions. People involved in thisown food production.[4] This led to a panel collaboration included Herbert Hollander, Marydiscussion at the 1971 National Conference on Klicka, and Hamed El-Bisi of the United StatesFood Protection that included examining CCPs Army Laboratories in Natick, Massachusetts,and Good Manufacturing Practices in Dr. Paul A. Lachance of the Manned Spacecraftproducing safe foods.[4] Several botulism cases Center in Houston, Texas[4] and Howard E.were attributed to under-processed low-acid Baumann representing the Pillsbury as its leadcanned foods in 1970-71. The United States scientist.[4] Food and Drug Administration (FDA) asked In order to insure that the food that would be Pillsbury to organize and conduct a training of canned foods for sent to space was safe, Lachance imposed strict program on the inspection [4] microbial requirements, including pathogenFDA inspectors. This 21 day program was limits (including E. coli, Salmonella, andfirst held in September 1972 with 11 days of and 10 days of canning plant Clostridium botulinum).[4] Using the traditionalclassroom lecture [4] end product testing method, it was soonevaluations. Canned food regulations (21 CFR 21 CFR 110, 21 CFR 113, and 21 CFR realized that almost all of the food 108, [5] were first published in 1969.[4] manufactured was being used on testing and114) Pillsbury's training program to the FDA in

5
1969, titled "Food Safety through the HazardPrinciple 2: Identify critical control points. Analysis and Critical Control Point System",A critical control point (CCP) is a point, step, or was the first time that HACCP was used.[4] procedure in a food manufacturing process at HACCP was initially set on three principles,which control can be applied and, as a result, a now shown as principles one, two, and four in food safety hazard can be prevented, the section below.[4] Pillsbury quickly adoptedeliminated, or reduced to an acceptable level. two more principles, numbers three and five, to Principle 3: Establish critical limits for each its own company in 1975.[4] It was furthercritical control point. A critical limit is the supported by the National Academy of Sciencesmaximum or minimum value to which a (NAS) that governmental inspections by thephysical, biological, or chemical hazard must FDA go from reviewing plant records tobe controlled at a critical control point to compliance with its HACCP system.[4] A secondprevent, eliminate, or reduce to an acceptable proposal by the NAS led to the development oflevel. the National Advisory Committee onPrinciple 4: Establish critical control point Microbiological Criteria for Foods (NACMCF)monitoring requirements. Monitoring in 1987.[4] NACMCF was initially responsibleactivities are necessary to ensure that the for defining HACCP's systems and guidelinesprocess is under control at each critical control for its application and were coordinated withpoint. In the United States, the FSIS is requiring the Codex Committee for Food Hygiene, thatthat each monitoring procedure and its led to reports starting in 1992 and further frequency be listed in the HACCP plan. harmonization in 1997.[4] By 1997, the seven HACCP principles listed below became thePrinciple 5: Establish corrective actions. standard.[4] A year earlier, the American SocietyThese are actions to be taken when monitoring for Quality offered their first certifications forindicates a deviation from an established HACCP Auditors.[6] (First known as Certifiedcritical limit. The final rule requires a plant's Quality Auditor-HACCP, they were changed toHACCP plan to identify the corrective actions to be taken if a critical limit is not met. Certified HACCP Auditor (CHA) in 2004.[7] Corrective actions are intended to ensure that HACCP expanded in all realms of the foodno product injurious to health or otherwise industry, going into meat, poultry, seafood,adulterated as a result of the deviation enters dairy, and has spread now from the farm to the commerce. fork.[4 Principle 6: Establish procedures for The HACCP seven principles ensuring the HACCP system is working as intended. Validation ensures that the plants Principle 1: Conduct a hazard analysis. do what they were designed to do; that is, they Plans determine the food safety hazards and are successful in ensuring the production of a identify the preventive measures the plan can safe product. Plants will be required to validate apply to control these hazards. A food safety their own HACCP plans. FSIS will not approve hazard is any biological, chemical, or physical HACCP plans in advance, but will review them property that may cause a food to be unsafe for for conformance with the final rule. human consumption.

6
Verification ensures the HACCP plan is School food and services adequate, that is, working as intended. Verification procedures may include such activities as review of HACCP plans, CCP APEDA records, critical limits and microbial sampling and analysis. FSIS is requiring that the HACCP The Agricultural and Processed Food plan include verification tasks to be performedProducts Export Development Authority by plant personnel. Verification tasks would(APEDA) was established by the also be performed by FSIS inspectors. Both Government of India under the FSIS and industry will undertake microbialAgricultural and Processed Food Products testing as one of several verification activities. Export Development Authority Act passed

Verification also includes 'validation' theby the Parliament in December, 1985. The process of finding evidence for the accuracy ofAct (2 of 1986) came into effect from 13th the HACCP system (e.g. scientific evidence forFebruary, 1986 by a notification issued in critical limitations). the Gazette of India: Extraordinary: Part-II Principle 7: Establish record keeping[Sec. 3(ii): 13.2.1986). The Authority procedures. The HACCP regulation requiresreplaced the Processed Food Export that all plants maintain certain documents,Promotion Council (PFEPC). including its hazard analysis and written1.1 ASSIGNED FUNCTIONS HACCP plan, and records documenting theIn accordance with the Agricultural and monitoring of critical control points, criticalProcessed Food Products Export limits, verification activities, and the handlingDevelopment Authority Act, 1985, (2 of of processing deviations. 1986) the following functions have been assigned to the Authority. HACCP application Development of industries relating to the scheduled products for Applied range export by way of providing It can apply to several food categories; sea financial assistance or otherwise food, bulk milk production line, Bulk Cream for undertaking surveys and and Butter Production Line, animal meat feasibility studies, participation in industry, Organic Chemical Contaminants in enquiry capital through joint Food, Corn Curl Manufacturing Plant, etc. ventures and other reliefs and subsidy schemes; USA Registration of persons as exporters Fish and fishery products of the scheduled products on payment of such fees as may be Fresh-cut produce prescribed; Juice and nectary products Fixing of standards and Food outlets specifications for the scheduled products for the purpose of Meat and poultry products

7
exports; Carrying out inspection of meat and meat products in slaughter houses, processing plants, storage premises, conveyances or other places where such products are kept or handled for the purpose of ensuring the quality of such products; Improving of packaging of the Scheduled products; Improving of marketing of the Scheduled products outside India; Promotion of export oriented production and development of the Scheduled products; Collection of statistics from the owners of factories or establishments engaged in the production, processing, packaging, marketing or export of the scheduled products or from such other persons as may be prescribed on any matter relating to the scheduled products and publication of the statistics so collected or of any portions thereof or extracts therefrom; Training in various aspects of the industries connected with the scheduled products; Such other matters as may be prescribed. 1.2 PRODUCTS MONITORED APEDA is mandated with the responsibility of export promotion and development of the following scheduled products:
Fruits, Meat and Meat Products. Poultry and Poultry Products. Dairy Products. Confectionery, Biscuits and Bakery

Products.
Honey, Jaggery and Sugar Products. Cocoa and its products, chocolates

of all kinds.
Alcoholic

and

Non-Alcoholic

Beverages.
Cereal and Cereal Products. Groundnuts, Peanuts and Walnuts. Pickles, Papads and Chutneys. Guar Gum. Floriculture

and

Floriculture

Products
Herbal and Medicinal Plants

In addition to this, APEDA has been entrusted with the responsibility to monitor import of sugar. 1.3 COMPOSITION OF THE APEDA AUTHORITY As prescribed by the statute, the APEDA Authority consists of the following members namely:
A Chairman,

appointed by the Central Government to the Government of India, exofficio

The Agricultural Marketing Advisor

One

Vegetables

and

their

member appointed by the Central Government representing the Planning Commission

Products.

Three members of Parliament of

8
whom two are elected by the House of People and one by the Council of States
Eight members appointed by the

Central Government representing

o Fruit and Vegetable Products

Industries
o Meat, o Other

Central Government representing respectively; the Ministries of the Central Govt.

Agriculture and Rural Development Commerce Finance Industry Food Civil Supplies Civil Aviation Shipping and transport Five members appointed by the

Poultry and Products Industries Scheduled Industries

Dairy

Products

o Packaging Industry Two members appointed by the

Central Government from amongst specialists and scientists in the fields of agriculture, economics and marketing of the scheduled products. FPO The FPO mark is a certification mark mandatory on all processed fruit products sold in India such as packaged fruit beverages, fruitjams, crushes and squashes, pickles, dehydrated fruit products, and fruit extracts, following the Food Safety and Standards Act of 2006.[1] The FPO mark guarantees that the product was manufactured in a hygienic 'food-safe' environment, thus ensuring that the product is fit for consumption. The standards have been in force since 1955 by the law of Fruit Products Order, after which the mark is named,[2][3][4] but the mark itself got a mandatory status only after the Food Safety and Standards Act of 2006. An FPO license is, in fact, necessary to start a fruit processing industry in India.[5] The agency that develops standards for this purpose and that which issues the mark is the Ministry of Food Processing Industries of the Government of India. Fruit Product Order (FPO), 1955

Central Government by rotation in the alphabetical order to represent the States and the Union Territories
Seven members appointed by the

Central Govt. representing

Indian

Council Research

of

Agricultural

National Horticultural Board National Agricultural Cooperative

Marketing Federation
Central

Food Research Institute

Technological

Indian Institute of Packaging Spices Export Promotion Council

and
Cashew Export Promotion Council. Twelve members appointed by the

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Fruit Products Order -1955, promulgated underto test their conformity according to the Section 3 of the Essential Commodities Act -specifications laid under FPO. 1955, with an objective to manufacture fruit &The Central Fruit Product Advisory Committee vegetable products maintaining sanitary andcomprising of the officials of concerned hygienic conditions in the premises and qualityGovernment Departments, Technical experts, standards laid down in the Order. It isrepresentatives of Central Food Technology mandatory for all manufacturers of fruit andResearch Institute, Bureau of Indian Standards, vegetable products including some non fruitFruits and Vegetable Processing Industry and products like non fruit vinegar, syrup andConsumer Organization for recommending sweetened aerated water to obtain a licenseamendments in the Fruit Product Order under this Order. Following minimum requirements are laid down in the Fruit Product CISH Order for hygienic production and qualityThe Central Institute for Subtropical standards: Horticulture (CISH) was initially set up as (i) Location and surroundings of the factory Central Mango Research Station in the home (ii) Sanitary and hygienic conditions ofland of world famous Dashehari variety of mango on 4th September, 1972 under the aegis premises of the Indian Institute of Horticultural (iii) Personnel hygiene Research, Bangalore. On 1st June, 1984, it was (iv) Portability of water upgraded to the level of a full-fledged Institute (v) Machinery & Equipment with installedand named as Central Institute of Horticulture for Northern Plains. It was renamed as Central capacity (vi) Quality control facility & Technical staff Institute for Subtropical Horticulture (CISH) on 14th June, 1995 for carrying out research work (viii) Product Standards on various aspects of subtropical fruits like (viii) Limits for preservatives & other additives mango, guava, papaya, and litchi, etc. Aonla, bael and jamun were also added in its mandate. This order was earlier implemented by Ministry It is located at a distance of 25 kms from of Food Processing Industries (now by FSSAI)Lucknow on Lucknow-Hardoi Road at through the Directorate of Fruit & VegetableRehmankhera in the vicinity of Kakori and Preservation, Headquarter at New Delhi. The Malihabad, the famous mango belt of Uttar Directorate has five regional offices withPradesh.Its experimental farms are spread over headquarter located at Delhi, Mumbai, Kolkata,an area of 132.5 ha. comprising 4 blocks (block Chennai and Guwahati as well as a sub-office at1-15.5 ha. block-II-35.5 ha, block III-37.42 ha Lucknow under Northern Region. The fieldand block IV-44.18 ha) located at officers of the Regional Offices undertakeRehmankhera. Its other campus comprising periodic inspections of the manufacturing units13.2 ha is located at Lucknow-Raebareli Road to ensure maintenance of hygienic conditions in where, besides facilities for training and the factory and draw random samples ofnursery staff quarters are also housed products from the factories as well as fromOBJECTIVES markets which are analyzed in the laboratories

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The institute pursues its mandate through the following objectives: research headquarter at Lucknow and Research Centres at Bangalore, Hyderabad, Pantnagar and Purara. CIMAP Research Centres are aptly Management of genetic resources of situated in different agro-climatic zones of the mandated fruit crops and their country to facilitate multi-location field trials conventional and molecular and research. A little more than 50 years since characterization its inception, today, CIMAP has extended its Crop improvement through breeding and wings overseas with scientific collaboration genetic engineering agreements with Malaysia. CSIR-CIMAP has Enhancing productivity through signed two agreements to promote bilateral improving quality and quantity of cooperation between India and Malaysia in planting materials using modern research, development and commercialization propagation techniques and rootstocks, of MAP related technologies. precision farming practices including mechanization and management of biotic CIMAPs contribution to the Indian economy and abiotic stresses through its MAPs research is well known. Mint Reduction in post-harvest losses through varieties released and agro-packages developed and popularised by CIMAP has made India the improved post-harvest management global leader in mints and related industrial practices, value addition and products. CIMAP has released several varieties diversification of products of the MAPs, their complete agro-technology Human resource development, transfer of and post harvest packages which have technology and evaluation of its sociorevolutionised MAPs cultivation and business economic impact scenario of the country. Data storage and retrieval on all aspects ROLE OF THE LAB AND POSITIONING of mandated crops CIMAP is a unique lab of its kind in the entire globe, way ahead of its time even at the time of its establishment. As a ripple effect of CIMAPs success and contribution, other research CIMAP establishments have now started seriously Central Institute of Medicinal and Aromatic Plants, popularly known as CIMAP, is a frontier considering MAPs in their portfolio. While conserving the plant genetic resources plant research laboratory of Council of systematically and undertaking world class Scientific and Industrial Research (CSIR). research work in plant science, CIMAP is Established originally as Central Indian equipping the nation with high-tech agriculture Medicinal Plants Organisation (CIMPO) in 1959, CIMAP is steering multidisciplinary high linked to industrial processing of MAPs. CIMAP is equipped with state-of-the-art quality research in biological and chemical multidisciplinary laboratories, ultra-modern sciences and extending technologies and instrumentation facilities and scientific services to the farmers and entrepreneurs of medicinal and aromatic plants (MAPs) with its expertise in agriculture, genetics and plant

11
breeding, molecular taxonomy, molecular and structural biology, plant biotechnology, biochemistry, microbiology, bio energy and chemical sciences, apart from development of herbal products. CIMAP, Lucknow houses the National Gene Bank of medicinal and aromatic plants, in addition to seed gene bank, tissue and DNA bank. Further, Field Gene Bank of different varieties of MAPs is maintained at CIMAP Lucknow and its four research centres situated across the country. CDRI
Clinical and Experimental Medicine Drug Target Discovery and Development Endocrinology Fermentation Technology Medicinal and Process Chemistry Microbiology Parasitology Pharmaceutics Pharmacokinetics and Metabolism Pharmacology

Toxicology The Central Drug Research Institute (CDRI) is one of the first laboratories to be established ITRC in India right after its independence. CDRI is among the thirty nine laboratories that are functioning under the aegis of the council of Motto: scientific and Industrial Research CSIR of India. CDRI was formally inaugurated on 17th "Safety to Environment and Health and Service Feb 1951 by the then Prime Minister of India, to industry" Jawahar Lal Nehru. Vision: CDRI is considered to be a pioneer research organization in the field of biomedical research From laboratory to field for societal benefit by where all the infrastructure and expertise are contributing in niche areas of toxicology. available to develop a drug right from its concept to market. The very latest techniques Mission: and methodologies are employed for IITR, a leader in toxicology research, developing drugs, diagnostics and vaccines. CDRI is a multidisciplinary research laboratory, endeavours to mitigate problems of human health and environment. The institute aims to employing scientific personnel from various areas of biomedical sciences. For administrativeaccomplish its goals through the following and scientific purposes the Institute's manpower objectives: has been grouped into 17 R & D divisions and few divisions providing technical and scientific Safety evaluation of chemicals used in industry, support. The following divisions of CDRI are agriculture and everyday life. involved in Research and Development. Mode of action of toxic chemicals/pollutants. Biochemistry Botany

12
Remedial/preventive measures to safeguard health and environment from pollutants. 40-project districts, which is an autonomous registered Society at district level. The District Project Coordination unit (DPCU) also forms Occupational health hazards due to exposure in part of the ATMA and promotes cooperation & chemicals industries, mines, agricultural fields coordination among the activities of the DPIUs. Establishing ATMA in project districts (40 at and environment. present) is an attempt to decentralize the Simple/rapid diagnostic tests for disorders process of planning and implementation at the district level. caused by industrial and environmental Diversified Agriculture Support Project (DASP) chemicals with the objective to accelerate the trends of Collect, store and disseminate information on diversification with the financial assistance from Rastriya Krishi Vikas Yojana (RKVY) toxic chemicals. since 2007 tends to intensify agricultural Human resource development for dealing with activities through farmers participation. The project intends to appoint a Chartered industrial and environmental problems. Accountant firm as Project Auditors to conduct Provide a platform to public and entrepreneurs the Audit of Project accounts of Project Implementation year 2011-12. to address queries and concerns regarding The Project Auditor would have responsibility safety/toxicity of chemicals, additives and to express an opinion on the financial products. statements of the project in accordance with accounting norms. Those standards require that the auditor should plan and perform the audit to UPDASP (DIVERSIFIED obtain reasonable assurance about whether AGRICULTURAL SUPPORT PROJECT) project financial statements are free of material misstatement and give true and fair view of the The GOUP has established a Project financial position and operating results of the Coordination Unit (PCU) registered under project activities as per objective of the project Societies Registration Act 1860 to monitor the and as per rules & regulation applicable. implementation of the Diversified Agriculture 2. Project Objectives Support Project. The PCU is implementing the The objective of the project is to increase project with the help of Project Implementing agricultural productivity and product diversity Units (PIUs) of 7 line departments eg.(1)PIU in Uttar Pradesh and enhance market Mandi (2) PIUs Fisheries and Food Processing opportunities and market access for the states working in 70 districts (3) PIU-PCDF working farmers, fishermen and livestock producers for in 44 districts.(4) PIUs Agriculture, increasing their income levels. In support of Horticulture and Animal Husbandry working in this objective, the project would foster 40 districts. Agriculture Technology increased private sector participation and Management Agency (ATMA) shall monitor investment in all facets of the agricultural and the district level extension activities under all allied sectors and promote more effective use of

13
government funds already allocated to these sectors, line departments and to private sectors through government sponsored investment grant scheme. 3. Project Description 1. Promoting Intensification and Diversification of Agricultural Productionby making extension and adaptive research more relevant and accessible to farmers; encouraging the development and introduction of more effective agricultural production systems; and reducing the risk associated with change, especially for small operators. 2. Upgrading Production System- Promotion of diversified, innovative agricultural, livestock and fish production systems, supported by an Investment Grant scheme specifically targeted at marginal landholders and the landless; along with livestock and fish up-grading programs, privatization of artificial insemination (AI) services, and improved livestock disease surveillance systems. 3. Expanding Market Opportunities and Increasing Access- by improving market infrastructure and involving private sector in market management to make it more responsive to farmers needs; promoting private sector participation in agribusiness; and improving market access through more market information, a better regulatory framework

14
and improving supply chain management; be repealed from the date to be notified by the construction of modern Agrimart for both sale Central Government as per the Food Safety and of agricultural inputs and farmers produce. Standards Act,2006. Till that date new 4. Piloting Risk Mitigation-The project standards are specified, the requirement and facilitates the introduction of risk management other provisions of the PFA Act, 1954 and Rules, 1955 shall continue to be in force as a instruments to farmers in the state of Uttar transitory provision for food standards. Pradesh through (i) Crop Specific Weather Insurance; (ii) Small & Marginal Farmers Small Industries Development Bank of India Draught Safety net insurance product; (iii) Warehouse receipt based financing & (iv) Price (SIDBI) Small Industries Development Bank of India Risk Management. (SIDBI), set up on April 2, 1990 under an Act of Indian Parliament, is the Principal Financial Institution for the Promotion, Financing and Development of the Micro, Small and Medium Prevention of Food Adulteration Act, 1954 Enterprise (MSME) sector and for Coordination of the functions of the institutions The Act was promulgated by Parliament inengaged in similar activities. 1954 to make provision for the prevention of Financial support is provided by way of adulteration of food, along with the Preventionrefinance to eligible Primary Lending of Food Adulteration Rules, 1955 which wasInstitutions (PLIs) such as banks, State incorporated in 1955 as an extension to the Act. Financial Corporations (SFCs), State Industrial Broadly, the PFA Act covers food standards,Development Corporations (SIDCs), State general procedures for sampling, analysis ofSmall Industries Development Corporations food, powers of authorized officers, nature of(SSIDCs) etc. for onward lending to MSMEs, penalties and other parameters related to food. financial assistance in the form of loans, grants, It deals with parameters relating to foodequity and quasi-equity to Non Government additives, preservative, colouring matters,Organisations / Micro Finance Institutions packing & labelling of foods, prohibition & (MFIs) for on-lending to micro enterprises and regulations of sales etc. Like FPO, amendmenteconomically weaker sections of society, in PFA rules are incorporated with theenabling them to take up income generating recommendation made by the Centralactivities on a sustainable basis and direct Committee of Food Standards (CCFS) whichassistance to MSMEs which is channelised has been setup by Central Government underthrough the Bank's network of 103 branch the Ministry of Health and Family Welfare offices. comprising members from different regions of the country. The provisions of PFA Act andWhile finance is the basic need of the MSMEs, Rules are implemented by State Governmentthey also require different non-credit facilities and local bodies as provided in the rules. to gain the extra mile in their endeavour to Prevention of Food Adulteration Act, 1954 willattain international competitiveness. Such

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requirements are equity capital, credit rating, facilitate greater and easier flow of credit technology transfer and upgradation, etc. SIDBI from the banking sector to the MSMEs has been constantly working on building various institutional mechanisms to cater to the GMP emerging needs of the MSME sector and has set-up various subsidiaries / associates viz. A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have SIDBI Venture Capital Ltd. (SVCL), a subsidiary of SIDBI set up in July,1999,legislated that pharmaceutical and medical is an asset management company,device companies must follow GMP presently managing two venture capitalprocedures, and have created their own GMP guidelines that correspond with their funds; legislation. Basic concepts of all of these Credit Guarantee Fund Trust for Microguidelines remain more or less similar to the and Small Enterprises (CGTMSE) in Julyultimate goals of safeguarding the health of the 2000 by Government of India and SIDBI,patient as well as producing good quality to provide credit guarantee support tomedicine, medical devices or active collateral free / third-party guarantee freepharmaceutical products. In the U.S. a drug loans extended by banks and lendingmay be deemed adulterated if it has passed all institutions for micro and smallof the specifications tests but is found to be enterprises (MSEs); manufactured in a condition which violates SME Rating Agency of India Ltd.current good manufacturing guideline. (SMERA) in September 2005, as anTherefore, complying with GMP is a mandatory MSME dedicated third-party ratingaspect in pharmaceutical manufacturing. agency to provide comprehensive,Although there are a number of them, all transparent and reliable ratings and riskguidelines follow a few basic principles: profiling Manufacturing processes are clearly India SME Technology Services Limited defined and controlled. All critical (ISTSL), set up in November 2005, processes are validated to ensure provides a platform for MSMEs to tap consistency and compliance with opportunities at the global level for specifications. acquisition of modern technologies Manufacturing processes are controlled, India SME Asset Reconstruction and any changes to the process are Company ltd (ISARC) is the country's evaluated. Changes that have an impact first MSME focused Asset on the quality of the drug are validated as Reconstruction Company striving for necessary. speedier resolution of non-performing assets (NPA) by unlocking the idle NPAs Instructions and procedures are written in clear and unambiguous language. (Good for productive purposes which would Documentation Practices)

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Operators are trained to carry out and

document procedures.
Records are made, manually or by

instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
Records of manufacture (including

distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the drugs minimizes

any risk to their quality.

A system is available for recalling any

batch of drug from sale or supply.

Complaints about marketed drugs are

examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence. GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.