Good Manufacturing Practices and Good Hygiene Practices

1. GMP and GHP

2. Brief background
O 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.

3. 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.

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
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.

6. GMP
GOOD MANUFACTURING
PRACTICES

7. Definition
O 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.

8. GMP contains ten principles
1. Writing procedures
2. Following written procedures
3. Documenting for traceability
4. Validating works
5. Designing facilities and equipment
6. Maintaining facilities and equipment
7. Job competence
8. Cleanliness
9. Component control
10. Auditing for compliance

9. 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

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

11. 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.

12. 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.

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.
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.

14. 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

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
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

17. Scope and use
O 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

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
O Environmental hygiene
O Hygienic production of food sources
O Handling, storage and transport
O 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
O Location
O Equipment
O Premises and rooms
Design and layout
O Internal structures and fittings
O Temporary/ mobile premises and vending machines
O Equipment
O Food control and monitoring equipment
O Containers for waste and inedible substances
Facilities
O Water supply
O Drainage and waste disposal
O Cleaning
O Personnel hygiene facilities and toilets
O Temperature control
O Air quality and ventilation
O Lighting
O Storage

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

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

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

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

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

26. THANK YOU