Thursday, December 2, 2010

GOOD MANUFACTURING PRACTICES



That combination of manufacturing and quality control procedures aimed at ensuring that products are constantly manufactured to there specifications. The U.S. Food and Drug Administration has designed the rules for cGMP (FDA, 1995). These include requirements related to the methods used in, and the facilities and controls used for, design, purchasing, manufacture, packaging, labeling, storage, installation, and servicing of all finished products intended for human use. As can be seen, these rules cover a broad range

GMP are prescribed to ensure that:-

* Factory is at proper location.
* Factory has right layout and building design.
* Raw materials used in the products are of right specifications.
* Manufacturing processes are properly prescribed & implemented to ensure right quality finished products.
* Adequate quality standards are in place
* All CCPs are specified by hazard analysis
* Finished products are released for market only after prescribed quality analysis
* These are stored and transport in hygienic manner
* All market returns are properly stored ,analyzed ,reworked or disposed of with proper procedure
* Traceability procedures is in place

All practices regarding the condition and measure necessary to ensure the safety and suitability of food at all stages of food chain.

Codex General Principles of Food Hygiene 

Identify the essential principles of food hygiene applicable throughout the food chain, to achieve the goal of ensuring that food is safe and suitable for human consumption

Codex General Principles of Food Hygiene

1. Provides a baseline structure for other, more specific, codes applicable to particular sectors

2. Such specific codes should be read in conjunction with this document audits appendix on HACCP and guidelines for its application.

Areas examined under GHP

1. Primary production

2. Establishment: design and facilities

3. Control of operation

4. Establishment: maintenance and sanitation

5. Establishment: personal hygiene

6. Transportation

7. Product information and consumer awareness

8. Training

1. Primary production

Hygienic practices should reduce the likelihood of introducing hazards that may be difficult or impossible to control at later stages of the food chain

Examples: pesticides, antibiotics, mycotoxins, microorganisms in foods eaten raw or fresh



2. Establishment: design

Evaluation of the premises takes into account:

· Location

· Equipment

· Facilities : water air lighting storage



3. Establishment: practice

“Good housekeeping” applies to the surroundings and the roof of the establishment

· Pest control starts at the boundaries of the premises

· Water management deals with incoming and used water

· Windows are closed or screened

· Internal surfaces are smooth and easy to clean

· Floors have rounded corners

· Ceilings and ducts are accessible for cleaning

· Dry zones are designed to remain dry

· Drains can be cleaned

· Cable trays carry cables, not dirt or dust

· Insectocuters are effective

· Only potable water is in contact with food

· Air handling systems deliver the required air quality (and not contaminants)

· Doors are closed when not used

3. Control of operation

· Control of food hazards through HACCP

· Hygiene control: Time & temperature

· Humidity

· Cross contamination

· Microbiological specifications

· Incoming materials (incl. packaging materials)

· Water, air, steam

· Management, documentation, recalls procedures.

Control: practice

· Keep potentially contaminated materials separated from uncontaminated ones

· Assure effectiveness of treatments

· Assure effectiveness of cleaning

· Assure reliability of measurements, tests and recording

· Perform hazard analysis when changes occur

· Assure updating of HACCP plan

5. Establishment: maintenance & sanitation

Objective to control possible sources of food contamination through

· Maintenance and cleaning

· Pest control systems

· Waste management

· Monitoring

Maintenance

Establishments and equipment should be kept in condition to:

· Facilitate sanitation procedures

· Function as intended, particularly at Critical Control Points (CCPs)

· Prevent contamination of food e.g. metal shards, flaking plaster, debris, chemicals, pests, dust etc.

Cleaning

Cleaning procedures involve

· Removing gross debris from surfaces

· Applying a detergent solution

· Rinsing with water

· Disinfection where necessary

Pest control

Good hygienic practices should

· Prevent pests from entering the premises

· Protect food from pests

· Eradicate infestations immediately

· Include regular inspections

5. Establishment: personal hygiene

To prevent food from being contaminated by the people who come in contact with it, personnel must receive clear instruction on the following:

· Health status

· Illness and injuries

· Personal cleanliness

· Personal behavior

6. Transportation

Measures should be taken to:

· Protect food from:

o Contamination sources

o Damage likely to render the food unsuitable for consumption

· Provide an environment which controls the growth of pathogenic or spoilage microorganisms and the production of toxins in food

7. Product information and consumer awareness

· Lot identification

· Product information

· Labelling

· Consumer education

Consumer information

Consumers should know enough about food

hygiene to be able to :

· understand the importance of product information

· make informed choices appropriate to the individual

· prevent contamination and growth or survival of food borne pathogens by storing, preparing and using it correctly


8. Training

· Awareness and responsibilities

· Training programmes

· Instruction and supervision

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