FST 156
GMP Audit
Name: Company name:
Group: Business Address:
Audit Date: Owner:
PROVISIONS YES NO REMARKS
GMP ORGANIZATION
Organization, Qualification, and Responsibilities
1. The production and the quality assurance/quality
control functions are headed by different
managers/heads.
2. Production manager have full authority and
responsibility to manage production of food products.
3. The production manager has knowledge, skill and
capabilities to assigned functions.
3.1. Adequate training in the field of food manufacture
in accordance with GMP.
3.1.1. Training conducted by qualified individuals.
3.1.2. Training conducted on a continuing basis
and with adequate frequency
3.1.3. Training in GMP is in accordance with written
programs approved by the company.
3.1.4. Records of training are maintained.
3.1.5. Appraisal of performance after the training.
3.2. Possess good practical experience in food
manufacture or any other related field.
4. The QA/QC manager/head have full authority and
responsibility in all quality assurance and quality
control duties.
5. The QA/QC manager have knowledge, skill and
capabilities to assigned functions.
5.1. Adequate training in the field of food
manufacture and in accordance with GMP.
5.1.1. Training conducted by qualified individuals
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5.1.2. Training conducted on a continuing basis
and with adequate frequency.
5.1.3. Training in GMP is in accordance with written
programs approved by the company.
5.1.4. Records of training are maintained.
5.1.5. Appraisal of performance after training.
5.2. Possess good practical experience in food
manufacture or any other related field.
6. Duties of every employee are clearly defined,
communicated and well understood.
7. Assigned duties are within an employee’s capacity to
perform.
8. The QA/QC unit responsible for the:
8.1. Approval/rejection of all components from raw,
packaging and labeling materials including bulk
and finished products
8.2. Approval/rejection of products manufactured or
packed or held under control by a third party
manufacturer
8.3. Approval/rejection of procedures related to
product quality or product specifications
8.4. Review of both production and QC records
8.5. Monitoring and controlling of the:
8.5.1. Manufacturing environment
8.5.2. Plant cleanliness
8.5.3. Production validation
8.5.4. Calibration
8.5.5. Training of personnel
8.5.6. Approval of supply materials and contract
parties
8.5.7. Products and materials against spoilage and
deterioration
8.5.8. Maintenance of records
PREMISES
Grounds
1. Grounds are constructed and maintained to protect
against weather, flood, ground seepage, and the access
and harboring of vermin, rodents, birds, insects or other
animals
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2. Measures are exercised to exclude pests, dirt and filth
of the plant grounds are bordered by grounds not under
the operator’s control
3. Methods for adequate maintenance of grounds
include, but are not limited to:
3.1. Good Housekeeping, i.e. proper storage of
equipment, removing of litters & cutting of weeds or
structures that may constitute harborage for pest?
3.2. Proper operating systems for waste treatment
and disposal in conformance with DENR regulation?
PLANT CONSTRUCTION AND DESIGN
1. Plant, buildings, and structures are suitable in size,
design and construction.
2. A ‘Master Plan’ diagram is provided to prevent cross
contamination and reduce carriage of dirt and potential
contamination around the factory.
3. Sufficient space for placement & operations of
equipment & storage of materials.
4. Adequate food safety controls through effective design
and construction including separation of operations.
5. Where appropriate, floors are:
5.1. Water proof, non-absorbent, washable and made
of non-slip material
5.2. Without crevices, and easy to clean and disinfect
5.3. Sloped for liquid to drain to trapped outlets
6. Where appropriate, walls are:
6.1. Water proof, non-absorbent, made of washable
materials
6.2. Sealed and free of insects
6.3. Light colored
6.4. Appropriate height for the operations
6.5. Smooth, without crevices, easy to clean and
disinfect
6.6. Properly coved between junctures
7. Ceilings are properly designed, constructed and
finished and easy to clean.
8. Windows and other openings properly constructed and
fitted with insect-proof screens.
9. Doors are provided with smooth, non-absorbent
surfaces and where appropriate self-closing and
close-fitting.
10. Drains are adequate in size with traps.
11. Where appropriate, are stairs, lift cages, auxiliary
structures properly situated and constructed.
12. There is separation of processing between food
products and non-food products.
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13. There is a separate space for cleaning mobile
equipment and storage of cleaning materials.
14. Locker/gowning room directly connected to but
separated from processing areas.
15. Toilets are not opened directly to production areas
and have adequate supply of water and ventilation.
16. There are defined areas and wherever applicable for:
16.1. Gowning/changing rooms for all personnel
16.2. Receiving of starting materials
16.3. Incoming goods quarantine
16.4. Sampling room
16.5. Storage of approved materials
16.6. Storage of reject materials
16.7. QC facilities
16.8. Preparation of materials
16.9. Processing operations
16.10. Equipment washing
16.11. Storage of cleaned, idle equipment
16.12. Major repair and maintenance activities
16.13. Storage of cleaning tools and supplies
16.14. Staging/storage of bulk products
16.15. Packaging/labeling operations
16.16. Quarantine storage for finished products
16.17. Storage/warehouse for approved finished
products
16.18. Canteen
17. Adequate natural or artificial lighting provided
throughout the establishment.
17.1. There is a protection against food
contamination in case of glass breakage
18. Adequate ventilation provided.
19. The direction of the air flow within the plant is never
from dirty area to a clean area
20. Ventilation openings are provided with a protecting
enclosure of non-corrodible material
21. Adequate screening or other protection against
pests.
EQUIPMENT
1. Food contact surfaces of equipment and utensils are:
1.1. Non-corrosive, easily and adequately cleanable
and maintained
1.2. Non-toxic, and designed to withstand the
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environment of intended use
1.3. With seams smoothly bonded
2. Equipment are suitably installed and located to
eliminate cross contamination and facilitate cleaning.
3. Holding, conveying and manufacturing systems
properly designed and constructed.
4. Controlled environment equipment fitted with proper
measuring devices.
4.1. Regulating instruments calibrated & maintained
4.2. Records of calibration provided & maintained
5. Clean and sanitized portable equipment and utensils
with product-contact surfaces properly stored.
6. Equipment are free from glass parts.
7. Equipment parts not lacquered nor painted.
8. Equipment allow sampling and measuring of product
quality.
D. SANITATION & HYGIENE
1. Personnel
1.1. Disease control
1.1.1. Medical records filed
1.1.2. No open lesions, including boils, sores or
infected wounds
1.1.3. No other possible source of microbial
contamination
1.1.4. Established/documented procedures for
disease control including specific instruction for all
personnel to report such health conditions to their
supervisors
1.2. Hygienic Practices
1.2.1. Established/documented procedures and
work instructions made known to all appropriate
personnel for maintaining cleanliness to include but are
not limited to:
1.2.1.1. wearing suitable outer garments during
operation
1.2.1.2. maintaining adequate personal
cleanliness
1.2.1.3. washing hands thoroughly (& sanitizing if
necessary) at all times when hands may have become
soiled/contaminated
1.2.1.4. removing all unsecured jewelry and
other objects that might fall into food, equipment or
containers and removing hand jewelry that cannot be
adequately sanitized during periods in which food is
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manipulated by hand
1.2.1.5. maintaining impermeable gloves in food
handling
1.2.1.6. wearing of hair restraints
1.2.1.7. storing clothing or other personal
belongings in appropriate areas
1.2.1.8. confining areas for eating food, chewing
gum, drinking beverages or using tobacco
1.2.1.9. taking other necessary precautions to
protect against contamination of food, food-contact
surfaces, or food-packaging materials with
microorganisms or foreign substances including, but not
limited to, perspiration, hair, cosmetics, tobacco,
chemicals, and medicines applied to skin
2. Education and Training
2.1. Training program on proper food handling
techniques and food protection principles established
and maintained
2.1.1. Training program filed
2.1.2. Continuous training program
2.2. Regular training
2.2.1. Instituted as scheduled
2.2.2. Validated training by:
- written exam
- actual or hands-on
3. Supervision
3.1. By competent personnel
3.1.1 Appropriate training
3.1.2. Length of experience
3.1.3. Number of years in current work
3.1.4. Actual plantilla
3.1.5. Number of re-training
3.2. Personnel responsible for identifying sanitation
features or food contamination problems
3.2.1. Educational background
3.2.2. Length of experience
3.2.3. Appropriate training
3.2.4. Number of years in current work
3.2.5. Actual plantilla
3.2.6. Number of re-training
4. Sanitary Facilities
4.1. Water supply
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4.1.1. Potable water
- easily accessible
- no cross contamination exists between
potable and non-potable water supply or sewage
- adequate volume and pressure
- records of potability test maintained
- chlorine level monitored
- free of foreign matter
- elevated tanks or facilities for its storage
kept clean and properly covered
4.1.2 Non-potable water
- identified circuits separated from potable
water
4.2. Effluent and Waste Disposal
4.2.1. System provided within the plant
4.2.2. Maintained in good order and repair and
conformed with DENR regulations
4.2.3. Effluent lines (including sewer systems) well
constructed and large enough to carry peak loads so as
to avoid contamination of potable water supplies
4.3. Changing facilities
4.3.1. Adequate and suitable
4.3.2. Conveniently located
4.4. Toilets
4.4.1. Adequate number of toilets provided
4.4.2. Designed and constructed to ensure
hygienic removal of waste matter
4.4.3. Presence of hand washing facilities with
sufficient supply of potable water, hand cleaning
preparation and suitable means of drying hands
4.4.4. Kept in good repair
4.4.5. Kept clean
4.4. Toilets
4.4.1. Adequate number of toilets provided
4.4.2 Designed and constructed to ensure hygienic
removal of waste matter
4.4.3. Presence of hand washing facilities with
sufficient supply of potable water, hand cleaning
preparation and suitable means of drying hands
4.4.4. Kept in good repair
4.4.5. Kept clean
4.5. Hand washing facilities in Processing Areas
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4.5.1. Adequate and conveniently located
4.5.2. Provided with sufficient supply of potable
water, hand cleaning preparation and suitable means of
drying hands
4.5.3. Furnished with properly trapped wastewater
pipe leading to drains
4.5.4. Kept in good repair
4.5.5. Kept clean
4.6. Disinfection facilities
4.6.1. Facilities provided
4.6.2. Made of non-corrosive materials, easily
cleaned, with suitable means of supplying potable water
in sufficient quantities
4.7. Facilities for Storage of Waste and Inedible
Materials
4.7.1. Facilities provided
4.7.2. Designed properly so as to prevent access
by pests and possible contamination of food, potable
water, equipment, building or roadways on the premises.
4.8. Eating Facilities
4.8.1. Facilities provided
4.8.2. Kept clean and in good repair
5. Maintenance and Sanitation
5.1. General Maintenance
5.1.1. Procedures for general maintenance of the
plant and its premises provided:
5.1.1.1. Establishments and equipment kept in
an appropriate state of repair and condition so as to
facilitate sanitation procedures to function as intended, to
prevent contamination
5.1.1.2. Cleaning/Disinfection method and
materials
5.1.1.3. Cleaning operations in buildings, fixtures
and other physical facilities of the plant done properly
5.1.1.4. Detergents, sanitizers and other supplies
used in cleaning and sanitizing procedures are safe and
effective for their intended uses, properly used, stored
and identified.
5.2. Cleaning Procedures and Methods
5.2.1. Cleaning procedures and methods provided
such as:
5.2.1.1. A separate or combined use of physical
methods (heat scrubbing, turbulent flow, vacuum
cleaning or other methods using the use of water, and
chemical methods using detergents, alkali or acids)
5.3. Cleaning Programs
5.3.1. Program provided ensure that all parts of the
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establishment are appropriately clean
5.3.2. Continually and effectively monitored for their
suitability and effectiveness documented (areas, items of
equipment and utensils to be cleared; responsibility for
particular tasks; method and frequency of cleaning; and
monitoring arrangements)
5.4. Animal and Vermin Control
5.4.1. Procedures for animal and vermin control
provided the following:
5.4.1.1. Animals or birds, other than those
essential as raw materials not allowed in any area of a
food plant
5.4.1.2. Measures taken to exclude pests from
the processing areas and to protect against the
contamination of foods on the premises by animals,
birds, and vermin
5.4.1.3. Insecticides or rodenticides used with
caution and restriction so as to prevent the
contamination of food, food contact surfaces or
packaging materials with toxic and hazardous residue
5.5. Pest Control
5.5.1. Preventing access by keeping the buildings
in good repair and condition (sealed holes, drains and
other places that are possible access to entrance of
pests)
5.5.2. Harborage and infestation controlled by
storing potential food sources in pest proof containers
and/or stacked above the ground away from the walls
5.5.3. Monitoring and detection regularly done
5.5.4. Eradication by means of chemical, physical
or biological agents dealt immediately and not adversely
affecting the food safety and suitability.
E. PRODUCTION AND PROCESS CONTROLS
1. Raw Materials
1.1. Checks quality upon receipt of raw materials
1.2. Checks quality during storage of raw materials
1.3. Checks quality during preparation for production
1.4. Check quantity during preparation for production
1.5. Checks potability of ice and/or water ingredients
2. Handling of Raw Materials
2.1. Containers protect the raw materials from
contamination and deterioration
2.2. Containers are properly labeled
2.3. Storage area protects the raw materials from
contamination and deterioration
2.4. Rejected materials are properly labeled and
segregated
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2.5. FIFO is practiced
3. Manufacturing Operations
3.1. Procedures and work instructions are provided
3.2. Change-over procedure is followed
3.3. Equipment and utensils are maintained in
sanitary condition though appropriate cleaning and
sanitizing
3.4. Physical factors (time, temperature, RH, Aw,
pressure, flow rate) and operations (freezing,
dehydration, heat processing, acidification, and
refrigeration) are monitored and controlled
3.5. In-process materials are protected from
contamination
3.6. Processed materials are protected from
contamination
3.7. Suitable equipment are used to protect food from
inclusion of metal or other extraneous materials
3.8. Steam used in contact with food is food grade
3.9. Process rejects are properly labeled and
segregated
3.10. Food manufacturing equipment and area are
used only for manufacturing human food
F. QUALITY CONTROL
1. Quality Management
1.1. Has established quality control system/SOPs
1.2. Quality Control monitoring:
1.2.1. Inspection and testing of raw materials
1.2.2. Inspection and testing of in-process
1.2.3. Sampling, inspection and testing of finished
products, where applicable:
1.2.3.1. batch documentation
1.2.3.2. sample retention program
1.2.3.4. stability studies
1.2.3.5. product complaints/CAPA
1.2.3.6. product recalls
1.2.3.7. maintained specifications of raw
materials and finished products
2. Testing of Reprocessed Products
3. Testing of Returned Goods
3.1. Returned products are properly identified and
segregated
3.2. Returned products are evaluated before
releasing for distribution
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3.3. Rejected returned products are:
3.3.1. recorded
3.3.2. Labeled and segregated
3.3.3. Properly disposed
4. Laboratory Facilities and Control
4.1. Separated from production area
4.2. Laboratory equipment and instruments are
suitable to the tests undertaken
G. DOCUMENTATION
1. Documents related to manufacture and operations are
prepared, reviewed, approved and distributed according
to written procedures.
2. Issuance, revision, superseding and withdrawal of all
documents are recorded.
3. With established procedure for retaining all
appropriate documents
4. Records of major equipment use, cleaning, sanitation,
sterilization, and maintenance show the date, time,
product and batch number of each batch processed
using the same equipment and the name of the person
who performed the cleaning and maintenance.
5. Specifications for raw materials, labeling and
packaging materials are established and documented,
H. QUALITY AUDIT
1. A Quality audit by either independent body or internal
audit team is conducted.
I. WAREHOUSING AND DISTRIBUTION
1. Warehouses are free from pests
2. No pesticide, disinfectant, toxic chemicals and others.
3. Stocks are organized.
4. A separate area is provided for rejects and product
returns.
5. Secured enough to prevent theft, tampering, etc.
6. FIFO system is practiced and a stock control system is
in place.
7. Premises are clean and orderly.
Inspected by: Conforme:
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