GMP and GHP

Brief backgroundO 1963 - The Codex Alimentarius Commission was created

by FAO and WHO to develop food standards, guidelines and related texts.

O 1969 - The Codex Alimentarius Commission brought out the Recommended International Code of Practice-General Principles of Food Hygiene GHP which has undergone four revisions .

O 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.

What is ISO ? O International Standards Organization

(ISO). ISO is a principal voluntary global leader in the establishment of guidelines for the establishment of private sector standards.

O 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.

SECTORSTANDARD OR SERIES OF

STANDARDSAutomotive 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.

Food safety standards : ISO 22000

O 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.

O 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.

GMPGOOD MANUFACTURING

PRACTICES

DefinitionO A GMP is a system for ensuring that

products are consistently produced and controlled according to quality standards.

O GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff.

GMP contains ten principles

1. Writing procedures2. Following written procedures3. Documenting for traceability4. Validating works5. Designing facilities and equipment6. Maintaining facilities and equipment7. Job competence8. Cleanliness9. Component control10. Auditing for compliance

Who needs GMP?O 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.

O All involved in food legislation and food law enforcement

Good Manufacturing Practice in food industry

O Personnel O Plant and grounds O Sanitary operationsO Sanitary facilities and controlO Equipment's and utensilsO Processes and controlsO Warehousing and distributionO Maximum defect action level

Significance of premises, equipment, product and process design in an effective GMP system

O 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.

O 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.

O 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.

Significance of manufacturing and

operating procedures in an effective GMP system O 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.

O Documentation of manufacturing procedures . The documentation forms a part of the comprehensive master manufacturing instructions (MMI) which is specific for each product.

O 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.

O Operating instructions should be written in clear, unambiguous instructional form, and should form a key part of operator training.

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.

O Access to material and product storage areas should be restricted to persons working in the designated area and to authorised persons.

O Materials and products should be stored under conditions specified and protected from contamination especially microbiological cross-contamination.

O Effective cleaning of storage premises and equipment must be carried out with the frequency and in well-designed cleaning schedules and instructions.

O 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.

Significance of Rejection of product and complaints handling in GMP

O Proper means of disposal should be considered for rejected products

O Material on the basis of complaints can be recovered by an appropriate method, provided - material is safe and suitable for such treatment

O Complaints procedure must be provided for channeling of all quality complaint reports

O Product quality complaints should be thoroughly investigated by the quality control manager

GHPGOOD HANDLING

PRACTICES

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

O To identify essential principles of food hygiene - throughout the food chain;

O Recommend a HACCP-based approach as a means to enhance food safety;

O Indicate how to implement those principles; and

O Provide guidance for specific codes which may be needed for - sectors of the food chain; processes; or commodities; to amplify the hygiene requirements

Scope and useO Protect consumers from illness/injury caused by

food

O Polices need to consider the vulnerability of different groups within the population

O Provide assurance that food is suitable for human consumption

O Provide health education programs which effectively communicate the principles of food hygiene to industry and consumers

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

awareness Training

Primary productionO Environmental hygieneO Hygienic production of food sourcesO Handling, storage and transportO Cleaning, maintenance and personnel hygieneEstablishment, 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

Establishment O LocationO EquipmentO Premises and rooms

Design and layoutO Internal structures and fittings O Temporary/ mobile premises and vending machinesO EquipmentO Food control and monitoring equipmentO Containers for waste and inedible substances

FacilitiesO Water supplyO Drainage and waste disposalO CleaningO Personnel hygiene facilities and toiletsO Temperature control O Air quality and ventilation O LightingO Storage

Control of operation Control of hazards

Time and temperature controlOSpecific process control

Water O In contact with foodO As a ingredientO Management and supervisionO Documentation and recordsO Recall procedures

Establishment, maintenance and sanitation

O Maintenance and cleaning O Cleaning procedures and methodsO Cleaning programmes O Pest control systemsO Prevent accessO Harborage and infestationO Monitoring and detection O EradicationO Waste managementO Monitoring effectiveness

Establishment, personal hygiene

O Heath statusO Illness and injuriesO Personal cleanlinessO Personal behaviorO Visitors

TransportationO Do not contaminate foods and packagingO Effective cleaning and disinfectedO Effective separation of different foods from

non food itemsO Protect from contamination – dust and fumesO Maintain temperature, humidity, atmosphere

and other conditions to protect the food from microbial growth

O Check temperature, humidity and other conditions

Product information and consumer awareness

O Lot identificationO Product informationO Labeling O Consumer education

Training Awareness and responsibilities Training programmes

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