Module 5: Implement Good Manufacturing Practice Procedure

Module 5: Implement Good Manufacturing
Practice Procedure
Introduction
Good Manufacturing Practices (GMP) is a system of processes, procedures,
and documentation that help ensure that products are consistently produced
and controlled according to quality standards. These practices are required in
order to conform to guidelines and regulations recommended by agencies that
control authorization and licensing for the manufacture and sale of food, drug
products, and active pharmaceutical products.
TOTAL QUALITY MANAGEMENT AND FOOD QUALITY SYSTEM

PRINCIPLES
Product Quality System Study
In 1999, the Department of Agriculture commissioned a study on

Global Competitiveness of Philippine Food products. One of 7 parts of study
was the product quality system study which looked into the conformance of
the Philippine food to global standards of safety and quality.
The study showed that detention at the product destination was a

major reason for low competitiveness of Philippine Food Products.
Products get detained for any of the following reasons:
* Presence of filth and decomposition

* Improper process for low acid foods
* Labeling violation
* Non-declaration of some additives
* Use of prohibited additives
* Microbiological standards not met
* Presence of chemical hazards
It was also noted, that inspections and audits by regulatory

agencies were done sporadically.
Since the study, there had been marked improvements in GMP

implementations in the companies who participated.
Companies who have established food safety management system are

exporters of fishery product, the USA and EU. This is due to the fact that
these countries had mandatory requirements for HACCP. Other companies
who have implemented food safety system are suppliers or sub-contractors
of multi-national such as nestle, Coca-Cola kraft, Mcdonalds and hotel
and restaurant chains.
A GMP and HACCP voluntary certification program was instituted by
the Bureau of Export Trade Promotions in collaboration with Bureau of
Fisheries and Aquatic Resources, Bureau of Food and Drugs and Food
Development Center, an agency of the National Food Authority. This
voluntary certification program had been successful as expected. Major
reason for not getting certification or not renewing certification in the cost.
Since most of the reasons for detention cited are related to the
manufacturing practices of the processor, a complimentary field observation
was done to evaluate the level of conformance to Good Manufacturing
Practices.
Some of the malpractices observed were as follows:
 Poor layout and lack of facilities such as scales, floors, drains, ceiling,
 toilets, hand washing facilities, employee lockers and lounge
 Poor design of fabricated equipment such as retorts, blanchers and

pasteurizers, grinders, etc.
 Personal hygiene malpractices:

- Improper / dirty attire
- Use of jewelries
- Hand washing techniques not followed (no soap, no

sanitizer)
- Use of bare hands when handling ready to eat foods
- Smoking and eating in work area
- Improper use of hair cover (hair nets or caps)
 Post harvest malpractices:
- Use of rattan baskets and use sacks as fish containers

- Inadequate icing of fish and meat
- Use of up to 50 kgs. baskets for fruits and vegetables
- Rough handling of fruits and vegetables
- Fruits and vegetable place on the ground
- Use of banned chemical products
 Processing Malpractices:
- Use of banned additives
- Inadequate thermal process for low acid food/many Filipino

ethnic food
- Improper sugar concentration for food processing

- Absence of thermometer used in food processing
- Inappropriate packaging materials
- Lack of food safety and precautionary measures
HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP)
HAZARD ANALYSIS is the identification of selective ingredients critical

process points and relevant human factors as they effect product safety.
CRITICAL CONTROL POINT is a point in time or a physical location at
which failure of control or preventive measure will expose the consumer to
unacceptable health risks.
To be able to manufacture products with high level of assurance that

they were safe, it is necessary to understand fully the criticality of the
process, the ingredients and all other components that make up the
contract. This is the goal of HACCP.
HACCP concept is more likely to detect the hazard during the food
production by having control over the process, the raw materials, the
environment and the people beginning as early in the production as
possible. Furthermore, this allows to determine the type of controls to be
done in the area determined to be critical one.
HACCP concept was developed jointly by the American Food

Industry and governmental agencies in the 1970’s for the use in the food
processing industry, was devised as an attempt to apply zero – defect
program to food processing. It is also a concept important in sanitation
and hygiene, a preventive system of control – because we want to pre-
empt contamination into getting in the system.
HACCP (Hazard Analysis Critical Control Points) Concepts
1. A preventive system of control particularly on biological hazard.
2. A system approach for estimating the risks in producing a food

product.
3. Universally organized system as the most effective way to prevent
food – borne illness. Groups control groups.
4. Science - based systematic, identifies specific hazards and

measures for their control to ensure food safety.
5. Capable of accommodating change, such as advances in equipment

design, processing procedure and technology department departments
and can be applied throughout the food chain from the primary
producers to the final consumer.
6. Applicable to establishments that produce, process, pack, trade,

transport and involved in food productions.
7. Has become synonymous with FOOD SAFETY.
7 HACCP (Hazard Analysis Critical Control Points) Principles
The 7 HACCP principles are as follows:
1. Hazard analysis
2. Identify critical control points

3. Establish control limits
4. Monitor critical limits
5. Establish corrective action in case of deviation from established

critical limits
6. Establish verification procedures to ensure that the system is

consistent
7. Establish record keeping procedures
Why is HACCP (Hazard Analysis Critical Control Points) Necessary?
HACCP is necessary because:
1. it has been proven as the most effective method of instituting food

safety;
2. critical areas are closely monitored so that risks of manufacturing,

selling unsafe products are reduced to the minimum; and
3. quality benefits due to increased awareness of hazards and

participation of people involved in the operation.
Other Benefits of HACCP (Hazard Analysis Critical Control Point)
1. Mechanisms that control safety also control food quality in general.
2. HACCP requires individual accountability, proper documentation and

efficiency of operation and thus improves productivity.
3. HACCP is targeted to benefit the consumer and is therefore

essential to good business practice.
CODE AND REGULATIONS
Good Manufacturing Control Points
GOOD MANUFACTURING PRACTICES (GMP) provides the sanitary

infrastructure for food safety that:
1. plants, grounds and buildings facilities emphasize pest control.
2. equipment designs should particularly ease in cleaning and
maintenance,
3. personal hygiene practices and facilities,
4. process control, storage and warehousing.
Contamination of food can be substantially minimized if good

manufacturing practices are adhered to. GMP embodied in administrative
order 208 (series of 1974) is a set of sanitary guidelines recommended for
compliance in the MANUFACTURE, PROCESSING, PACKING, HOLDING
AND STORAGE OF FOODS. This is applicable to all food processing plants,
institutional and domestic kitchens or food service establishments at all
levels of operations.
GMP helps ensure the production of pure and unadulterated food,

which is a major provision of the FOOD, DRUG AND COSMETIC ACT OF
THE PHILIPPINES UNDER REPUBLIC ACT 3720. Sanitary inspectors from
the BFAD, some municipalities, cities or provinces are responsible for
enforcing the general provision of the act.
Current GMP Regulations
1. These tell what kind of buildings, facilities, equipment and

maintenance needed, and the errors to avoid and ensure sanitation.
2. They also deal with such matters as building designs and

construction, lighting, ventilation, toilet, and washing facilities,
cleaning of equipment, materials handling and vermin control.
Many food materials are intended for further processing and
manufacture into finished foods. Such processing does not relieve the
raw materials from the requirements of cleanliness and freedom from
deleterious impurities.
Foods that are free from contamination when they are shipped
sometimes become contaminated in route. This emphasizes the
importance of existing proper storage conditions in vessels, railroad
cars, or other conveyances. All shippers should pack their products so
as to protect them against spoilage or contamination in route and
should urge carriers to protect the merchandise by maintaining
sanitary conditions and segregating them from other cargoes which
might contaminate it.
GMP (Good Manufacturing Practices) covers:
1. plant and grounds
- well kept
2. equipment and utensils

- materials used; wood, stainless steel
- resistance to corrosion (acid in food corrosion
leach out)
3. sanitary facilities and control

- hand washing facilities
- rodent / insect control facilities
4. sanitary operations
- detergents effective and safe
- SOP in terms of cleaning equipment
- after production activities

5. process and control
- temperature gauges / vacuum gauges / heater

controls in good working conditions
6. personnel hygiene
- do they work when they’re sick?

Activity
Make your own Good Manufacturing Practice Procedures using the diagram
below. State some points to follow in manufacturing foods inside the laboratory
area.
GOOD MANUFACTURING
PRACTICES
PROCEDURES

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Module 5: Implement Good Manufacturing

TOTAL QUALITY MANAGEMENT AND FOOD QUALITY SYSTEM

Product Quality System Study

In 1999, the Department of Agriculture commissioned a study on

The study showed that detention at the product destination was a

* Presence of filth and decomposition

It was also noted, that inspections and audits by regulatory

Since the study, there had been marked improvements in GMP

Companies who have established food safety management system are

Some of the malpractices observed were as follows:

 Poor design of fabricated equipment such as retorts, blanchers and

 Personal hygiene malpractices:

- Hand washing techniques not followed (no soap, no

- Use of bare hands when handling ready to eat foods

- Smoking and eating in work area

- Improper use of hair cover (hair nets or caps)

 Post harvest malpractices:

- Use of rattan baskets and use sacks as fish containers

- Use of banned additives

- Inadequate thermal process for low acid food/many Filipino

- Improper sugar concentration for food processing

- Lack of food safety and precautionary measures

HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP)

HAZARD ANALYSIS is the identification of selective ingredients critical

To be able to manufacture products with high level of assurance that

HACCP concept was developed jointly by the American Food

HACCP (Hazard Analysis Critical Control Points) Concepts

1. A preventive system of control particularly on biological hazard.

2. A system approach for estimating the risks in producing a food

4. Science - based systematic, identifies specific hazards and

5. Capable of accommodating change, such as advances in equipment

6. Applicable to establishments that produce, process, pack, trade,

7. Has become synonymous with FOOD SAFETY.

7 HACCP (Hazard Analysis Critical Control Points) Principles

The 7 HACCP principles are as follows:

2. Identify critical control points

5. Establish corrective action in case of deviation from established

6. Establish verification procedures to ensure that the system is

Why is HACCP (Hazard Analysis Critical Control Points) Necessary?

HACCP is necessary because:

1. it has been proven as the most effective method of instituting food

2. critical areas are closely monitored so that risks of manufacturing,

3. quality benefits due to increased awareness of hazards and

1. Mechanisms that control safety also control food quality in general.

2. HACCP requires individual accountability, proper documentation and

3. HACCP is targeted to benefit the consumer and is therefore

CODE AND REGULATIONS

Good Manufacturing Control Points

GOOD MANUFACTURING PRACTICES (GMP) provides the sanitary

Contamination of food can be substantially minimized if good

GMP helps ensure the production of pure and unadulterated food,

Current GMP Regulations

1. These tell what kind of buildings, facilities, equipment and

2. They also deal with such matters as building designs and

GMP (Good Manufacturing Practices) covers:

1. plant and grounds

2. equipment and utensils

3. sanitary facilities and control

- after production activities