GMP and GHP

Good Manufacturing Practices and Good Hygiene Practices

1. GMP and GHP

2. Brief background 1963 - The Codex Alimentarius Commission was created by FAO and WHO to develop food standards , guidelines and related texts . 1969 - The Codex Alimentarius Commission brought out the Recommended International Code of Practice-General Principles of Food Hygiene GHP which has undergone four revisions . 2005- The ISO (International Organization for Standardization ) stepped in and brought out ISO 22000:2005 . Harmonize on a global level, Food safety management systems - Requirements for any organization in the food chain.

3. What is ISO ? International Standards Organization (ISO) . ISO is a principal voluntary global leader in the establishment of guidelines for the establishment of private sector standards. Since ISO 22000 is a generic food safety management standard , it can be used by any organization directly or indirectly involved in the food chain .

4. SECTOR STANDARD OR SERIES OF STANDARDS Automotive ISO/TS 16949:2002 Education IWA 2:2007 Energy PC 242, ISO 50001 Food safety ISO 22000:2005 Information security ISO/IEC 27001:2005 Health care IWA 1:2005 Local government IWA 4:2009 Medical devices ISO 13485:2003 Petroleum and gas ISO/TS 29001:2007 Ship recycling ISO 30000:2009 Supply chain security ISO 28000:2007 The tremendous impact of ISO 9001 and ISO 14001 on organizational practices and on trade has stimulated the development of other ISO standards and deliverables that adapt the generic management system to specific sectors or aspects.

5. Food safety standards : ISO 22000 ISO 22000 integrates the Codex Alimentarius Commission’s 7 principles of HACCP and dynamically combine it with PRPs necessary to control and reduce any food safety hazards . PRPs (PRE-REQUISITE PROGRAM) are also referred to as good hygienic practices(GHP ), good agricultural practices, good production practices , good manufacturing practices(GMP ), good distribution practices, and good trading practices .

6. GMP GOOD MANUFACTURING PRACTICES

7. Definition A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards . GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff.

8. GMP contains ten principles Writing procedures Following written procedures Documenting for traceability Validating works Designing facilities and equipment Maintaining facilities and equipment Job competence Cleanliness Component control Auditing for compliance

9. Who needs GMP ? Company, chairmen, presidents, chief executives, General managers, Plant managers, Technical managers, Quality assurance managers, Food hygiene managers, Production managers, Plant engineers, Warehouse managers, Distribution managers, Everyone involved in training. All involved in food legislation and food law enforcement

10. Good Manufacturing Practice in food industry Personnel Plant and grounds Sanitary operations Sanitary facilities and control Equipment's and utensils Processes and controls Warehousing and distribution Maximum defect action level

11. Significance of premises, equipment, product and process design in an effective GMP system Premises : GMP states that buildings should be located, designed, constructed, adapted and maintained to suit the operations carried out in them and to facilitate the protection of materials and products from deterioration/ contamination. Equipment's : GMP states that equipment should be designed, constructed, adapted, located and maintained to suit the processes and products for which it is used; to facilitate protection of the materials handled from contamination. Product and process design - Products and processes should be so designed to ensure that the end-product meets consumer expectation within the intended duration & circumstances of use.

12. Significance of manufacturing and operating procedures in an effective GMP system All operations and processes used in manufacture be capable of consistently yielding finished products that conform to their specifications and are suitably protected against contamination or deterioration. Documentation of manufacturing procedures . The documentation forms a part of the comprehensive master manufacturing instructions (MMI) which is specific for each product. An MMI can be confirmed only if, trials are carried out to establish whether the methods and procedures specified therein are suitable for factory production, and capable of consistently yielding products. Operating instructions should be written in clear, unambiguous instructional form, and should form a key part of operator training.

13. Significance of storage and movement of product in GMP The following points are highlighted in GMPs with respect to the storage and movement of raw materials, intermediate products and finished products. Access to material and product storage areas should be restricted to persons working in the designated area and to authorised persons. Materials and products should be stored under conditions specified and protected from contamination especially microbiological cross-contamination . Effective cleaning of storage premises and equipment must be carried out with the frequency and in well-designed cleaning schedules and instructions . Products that have been recalled or returned, and batches that have been rejected should be marked, physically segregated and placed in an entirely separate storage facility .

14. Significance of Rejection of product and complaints handling in GMP Proper means of disposal should be considered for rejected products Material on the basis of complaints can be recovered by an appropriate method , provided - material is safe and suitable for such treatment C omplaints procedure must be provided for channeling of all quality complaint reports Product quality complaints should be thoroughly investigated by the quality control manager

15. GHP GOOD HANDLING PRACTICES

16. GHP compliance covers the minimum sanitary and hygiene practices for food processors, such as hotels and restaurants, to ensure that food is safe and suitable for human consumption. OBJECTIVES OF GHP To identify essential principles of food hygiene - throughout the food chain; Recommend a HACCP-based approach as a means to enhance food safety; Indicate how to implement those principles; and Provide guidance for specific codes which may be needed for - sectors of the food chain; processes; or commodities; to amplify the hygiene requirements

17. Scope and use Protect consumers from illness/injury caused by food Polices need to consider the vulnerability of different groups within the population Provide assurance that food is suitable for human consumption Provide health education programs which effectively communicate the principles of food hygiene to industry and consumers

18. ELEMENTS OF GHP Primary production Establishment design facilities Control of operation Establishment personal and hygiene Transportation Product information consumer awareness Training

19. Primary production Environmental hygiene Hygienic production of food sources Handling, storage and transport Cleaning, maintenance and personnel hygiene Establishment, design and facilities Design and layout permit appropriate maintenance, cleaning and disinfections Surfaces and materials in particular those in contact with food are non- toxic in intended use, Suitable facilities are available for temperature, humidity and other controls Effective protection against pest access

20. Establishment Location Equipment Premises and rooms Design and layout Internal structures and fittings Temporary/ mobile premises and vending machines Equipment Food control and monitoring equipment Containers for waste and inedible substances Facilities Water supply Drainage and waste disposal Cleaning Personnel hygiene facilities and toilets Temperature control Air quality and ventilation Lighting Storage

21. Control of operation Control of hazards Time and temperature control Specific process control Water In contact with food As a ingredient Management and supervision Documentation and records Recall procedures

22. Establishment, maintenance and sanitation Maintenance and cleaning Cleaning procedures and methods Cleaning programmes Pest control systems Prevent access Harborage and infestation Monitoring and detection Eradication Waste management Monitoring effectiveness

23. Establishment, personal hygiene Heath status Illness and injuries Personal cleanliness Personal behavior Visitors

24. Transportation Do not contaminate foods and packaging Effective cleaning and disinfected Effective separation of different foods from non food items Protect from contamination – dust and fumes Maintain temperature, humidity, atmosphere and other conditions to protect the food from microbial growth Check temperature, humidity and other conditions

25. Product information and consumer awareness Lot identification Product information Labeling Consumer education Training Awareness and responsibilities Training programmes

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