LEC 17 crop production and distribution.pptx

Crop production

1. 17. GMP, HACCP, FSSAI, CODEX ALIMENTARIUS AND ISO CERTIFICATION

2. Good Manufacturing Practices (GMP) To maintain food quality and safety in food processing industries Good Hygienic Practice (GHP), Good Manufacturing Practice (GMP), Food Safety Management Systems (FSMS) were formulated under HACCP/ISO 22000 and Quality Management Systems under ISO 9001 . Good Manufacturing Practices (GMP) refers to the practices which manufacturers, processors, and packagers should take as proactive steps to ensure that their products are safe, pure, and effective. GMP ensures the elimination or minimization of the chances of contamination during food manufacturing .

3. Contd., It is achieved by addressing record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Any failure to comply with GMP resulted in recall, seizure, fines, and imprisonment. The manufacturer has the liberty to decide the manufacturing process with all safety and quality of food. It protects the consumer from purchasing low standard or even dangerous product. The first GMP publication was in 1963 and the present regulation appear in Part 210 of Code of Federal Regulations published by USFDA.

4. Importance of GMP • To minimize contamination and eliminate error to produce product of consistent quality. • Final testing to detect contamination or errors may not ensure food safety and quality in the final product. • Conformance to the predetermined specifications of the product. • Reduce rejections and recalls of the final product. • Satisfy the customers

5. Principles of GMP Design and construct the facilities and equipment properly Follow written procedures and instructions Document the work Validate the work regularly Monitor facilities and equipment Write step by step operating procedures and work on instructions Design, develop and demonstrate job competence Protect against contamination Control components and product related processes Conduct planned and periodic audits

6. Parts of GMP The five important factors of GMP to assure the quality and safety of production and processing of food products are Premises, Procedures, People, Process and Product.

7. For premises and materials General requirements Location and surroundings b) Building and premises c) Water system d) Disposal of waste 2. Warehousing area 3. Production area 4. Ancillary areas for rest and refreshment 5. Quality control system for separate independent areas for quality control laboratories 6. Personnel in production and QC lab shall be qualified and experienced 7. Checking health, clothing and sanitation of workers

8. 8. Manufacturing operations & controls should perform by trained personnel under direct supervision of technical staff approved by the licensing Authority 9. Sanitation in manufacturing premises 10. Raw materials shall store under appropriate storage condition with label and follow ‘first in/first expiry’–‘first out’ rule 11. Equipment shall be located, designed, constructed, adapted and maintained to suit the operations to be carried out 12. Documentation and records 13. Labels and other printed materials 14. Quality assurance - To understand key issues and specific requirements in quality assurance to resolve it. 15. Self-inspection and Quality audit

9. 16. Specifications: For raw material & packaging material, product containers & closures, in-process & bulk products 17. Master formula records: Related to all manufacturing procedures for each product and batch size to be manufactured. 18. Packaging records including name, volume, ingredients of product, description of package, detail of in-process control. 19. Standard operating procedures (SOP), and Records 20. Reprocessing and recording 21. Distribution records 22. Validation 23. Product recalls - A prompt and effective recall system of defective products shall be devised for timely information of all concerned stockists, wholesalers, suppliers, up to the retail level within the shortest period. 24. Complaints and adverse reactions

10. II. Requirements of plant and Equipments Design and Construction of Equipments Installation and Location for Equipments in Industry Maintenance of Equipments

11. Hazard Analysis Critical Control Point (HACCP) The HACCP is a worldwide-recognized systematic and preventive approach that addresses biological, chemical and physical hazards through anticipation and prevention, rather than through end-product inspection and testing. The application of the HACCP system is compatible with the implementation of TQM (Total Quality Management) systems such as the ISO 9000 series and Good Manufacturing Practices (GMPs). HACCP is a management system to ensure food safety through the analysis and control of hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the final product.

12. Definitions Critical Control Point: A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. CCP Decision tree: A sequence of questions to assist in determining whether a control point is a CCP. Control point: Any step at which biological, chemical or physical factors can be controlled. Corrective action: Procedures followed when a deviation occurs in order to correct the deviation. Deviation: Failure to meet a critical limit

13. Definitions Critical Limit: A maximum/minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce the occurrence of a food safety hazard to an acceptable level. Hazard: A biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control. Hazard Analysis: The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP Plan. Step: A point, procedure, operation or stage in the food system from primary production to final consumption.

14. HACCP Plan HACCP Plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed. In the HACCP plan, there are five preliminary tasks to be accomplished before approaching the HACCP principles for each products and processes Assemble the HACCP team Describe the food and its distribution Describe the intended use and consumers of the food Develop a flow diagram of the process Verification of the flow diagram

15. HACCP principles HACCP is a systematic approach to the identification, evaluation and control of food safety hazards based on the following seven principles.

16. Principles of HACCP Conduct a hazard analysis: It involves identification and evaluation of hazards . Develop a list of hazards that are likely to cause injury or illness if not effectively controlled. The hazard evaluation is determination of the degree of risk to the user from the identified hazard or based on the severity of the potential hazard. Severity is the seriousness of the consequences of exposure to the hazard. Determine the critical control points (CCP): From the information developed during the hazard analysis, CCP decision tree can be used as a tool. Critical control points are located at any step where hazards can be prevented, eliminated, or reduced to acceptable levels. CCP must be used only as product safety measures.

17. Contd., 3. Establish critical limits: A critical limit distinguish safe and unsafe operating conditions of CCP by establishing a maximum or minimum limit for various parameters such as temperature, pH, time, salt level, chlorine level etc. 4. Establish monitoring procedures: Monitoring of the process at CCP by physical measurements or observations to take action either by bring the process back to control or by taking corrective actions. For future verification keep accurate records to establish that critical limits have been met.

18. 5. Establish corrective actions: It includes an evaluation process to determine the cause of the problem and eliminate/correct the cause and disposition of the cause to prevent the reoccurrence. It is important to develop and maintain a record on the corrective actions that have been taken. 6. Establish verification procedures: Verification is to determine the validity of the HACCP plan and that the system is operating according to the plan. It is to make sure that the corrective action is effective in preventing the hazards identified. 7. Establish record-keeping and documentation procedures: Keep records from the development of the system and its operation and also address all regulatory requirements. Contd.,

19. Food Safety and Standards Authority of India (FSSAI) The Indian parliament has the Food Safety and Standards Act, 2006 by consolidating eight food related laws existed. • Prevention of Food Adulteration Act, 1954 • Fruit Products Order, 1955 • Meat Products Order, 1973 • Vegetable Oil Products (Control) Order, 1947 • Edible Oil Packaging (Regulation) Order, 1998 • Solvent Extracted Oil, Deoiled Meal and Edible Flour (Control) Order, 1967 • Milk and Milk Products Order, 1992 • Essential Commodities Act, 1955 (relating to food)

20. FSSAI According to the FSS Act, 2006 the Food Safety and Standards Authority of India (FSSAI) was established by Government of India on 5 August 2011 under the Ministry of Health and Family Welfare. Its mandate is for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption. The Head Office of the Authority is located at FDA Bhavan , Kotla Road, New Delhi with 5 regional offices.

21. Food Authority Food Authority is the apex body and a single reference body for all matters related to food safety and standards in the country. The Food Authority is assisted and advised by Scientific Panels , Scientific Committee and Central Advisory Committee. There are 22 members of various ministries and departments such as Agriculture, Commerce, Consumer Affairs, Food Processing, Health, Legislative Affairs and representatives of farmers, scientists, technologists, small scale industries and retail organizations, with one third representations of women.

22. Administrative structure

23. Functions  Prescribe the standards and guidelines in relation to food  Specify the limits of food additives, contaminants, irradiated foods, etc.  Lay down food labelling standards  Lay down methods of sampling, analysis and exchange of information among enforcement agencies  Prescribe the procedures and guidelines for accreditation of certification bodies and laboratories  Introduction of rapid alert system on incidence of biological risk, contaminants, etc.

24.  Enforcement of quality control of imported food in India  Provide training programmes for persons in food businesses  Integrated response to strategic issues like Novel foods, Health Foods, Nutraceutical, GM foods, International trade, etc.  Decentralisation of licensing for manufacture of food products  Adjudication of causes related to food Contd.,

25. Divisions There are 11 divisions in FSSAI such as standards division, regulation/codex division. Regulatory compliance/surveillance division, human resource division, vigilance and training division, finance division, imports division, risk assessment and R&D division, FSMS division, general administration division and legal division. For quality assurance, FSSAI notified 112 NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited labs , 72 state labs and 14 referral labs. FSSAI issues three types of license based on the annual turnover of food business: Registration: For Turnover less than ₹12 Lakh State License: For Turnover between ₹12 Lakh to ₹20 Crore Central License: For Turnover above ₹20 Crore

26. Codex Alimentarius Commission (CAC) Codex Alimentarius is the Latin word for "food code". It is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. Codex Alimentarius Commission (CAC) is a body that was established in 1963 by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) with the aim of protecting the health of consumers and ensure fair practices in the international food trade.

27. Codex The secretariat of Codex is at Rome and is funded jointly by the FAO and the WHO. There are 170 countries , including India as Codex members. The first meeting was held in 1963 and in every two years meeting is held in Rome or Geneva. World Trade Organization recognized Codex Alimentarius as an international reference point for the resolution of disputes on food safety and consumer protection. The Codex Alimentarius includes general provisions for contaminants, food additives, food hygiene, pesticide residues, veterinary drug residues, inspection and certification, labelling and presentation, methods of analysis and sampling.

28. Contd., It has advisory potential for Codes of Practice, Guideline and other recommended measures. The general standards of CAC cover food labelling, food hygiene, food additives and pesticide residues, procedures for assessing the safety of foods, import and export inspection and certification systems for food, those which relate directly to the consumers. Directorate General of Health Services (DGHS) under the Ministry of Health and the Ministry of Food Processing Industries are closely associated with the activities of Codex Alimentarius in India.

29. Mandates  Protect the health of consumers and ensure fair trade practices in food  Coordinate all food standards undertaken by international governmental and non-governmental organizations  Determine priorities and guide in the preparation of draft standards  Publish finalized standards in Codex Alimentarius  Amend published standards

30. Main organizational elements  Commission  Executive committee  Codex secretariat  Codex subsidiary bodies  General subject committees (horizontal committee)  Commodity committees (vertical committee)  FAO/WHO coordinating committee  Ad hoc intergovernmental task forces

31. Membership Membership is open to all nations notified by Director-General of FAO/WHO to their desire to be considered as members of the commission. Those nations recommended by FAO/WHO or UN member nations permitted only to attend Codex sessions referred as observers, can address the Commission but cannot vote. The Commission may adopt and amend its own Rules of Procedure that shall come into force upon approval by Director-General of FAO/WHO. Indian government is organized to develop and submit national position at Codex as ‘Codex India’, the National Codex Contact Point (NCCP), is located at Directorate General of Health Services, Ministry of Health and Family Welfare, GoI .

32. It coordinates and promotes Codex activities in India with the National Codex Committee. Major responsibilities of NCC are: Advise government on food standardisation , food quality and safety issues Provide important inputs to the government to ensure quality and safety of food to the consumers and maximise the development of industry and expansion of international trade.

33. International Organization for Standardization (ISO) ISO is an independent international non-governmental standard setting organisations with 167 countries as members, to standardize quality standards for any product. It was founded on 23 February 1947 , headquarter in Geneva , Switzerland. ISO is the most internationally accepted organisation with wide use in international trade as its standards are voluntary in nature. ISO provides specifications for products, services and systems, to ensure quality, safety, reliability and efficiency facilitating international trade. There are more than 24000 ISO standards covering almost all sectors such as technology, food safety, quality management systems, environment management, agriculture and healthcare.

34. Contd., An International Standard is a document containing practical information and best practice . It often describes an agreed way of doing something or a solution to a global problem. ISO members representing each country, meet annually at General Assembly. It includes a council with 20 members for guidance, governance and annual budgeting and a technical committee with 250 members to develop ISO standards. ISO guides covering ‘matters relate to international standardization’ are named in the format of “ISO[/IEC] Guide N:yyyy: Title”. For example: ISO/IEC Guide 65:1996 General requirements for bodies operating product certification.

35. Importance of ISO certification Ensures quality satisfaction to the consumers International recognition Increased revenue by increased productivity and better financial performance Mutual beneficial supplier relationships Meet government tender eligibility Improve credibility Improved process integration Better marketing and international trade opportunities Identify safety issues of products and services

36. A series of standards developed by the technical committee of ISO and approved in 1987 for the establishment and management of quality in an organization is called ISO 9000 . It provides a framework for continuous improvement in quality of most of the product and services in the market.

37. ISO standards ISO 9001 Meets the customer expectation on company product and services ISO 14001 Ensure that the organization follow effective environmental management system. OHSAS 18001 Effective health and safety management system ISO 20000 Proving best practice in IT & improvement in the delivery of IT services ISO 22000 Company has effective food safety management ISO 27000 Information security management system (ISMS). ISO 13485 Medical devices quality management ISO 17025 Management system for quality, administrative and technical operations of laboratories ISO 26000 Social responsibilities of customers, employees, communities, and other stakeholders ISO 50001 Best energy management practices GMP (Good Manufacturing Practice) Ensure consistency in quality manufacturing of products HACCP (Hazard Analysis and Critical Control Points) Process control based system for food safety.

38. ISO only develops a standard if there is a market need for it.  International Standards are created by EXPERTS from industry, government, consumer organizations, academia, non-governmental organizations, and more.  MEMBERS’ have to identify the experts and ensure an active voice for their country.  The ISO Central Secretariat – ISO/CS – coordinates the development process and publishes the standards. Experts, Members and ISO/CS plays major role in the development ISO standards.