LOGO:

GMP Manual
(Based on cGMP requirements according to AO 153)

Our Company
Street Address
City, State
Country
Postal Code

Page 1 of 18

Scope
Write a paragraph here to clearly identify the scope of your system.
Include the products, product categories, processes and production sites
that are included in your system.

Normative References
Administrative Order 153 issued by FDA.
List other references used in the development of your manual

Terms and definitions

List terms that you use that should be defined.
Maybe Codex Alimentarius on Good Hygiene Practices!

Instructions for this Manual:

Use the AO 153 as a reference as you modify this manual to apply to your
System. Replace the words The Company and The Companys with
your company name. Any red text is instructional and should be deleted
from the manual.
The headers are in the following Microsoft Word Styles associated with
this DOCument:

Section Heading (followed by the tab to bring line to the page edge)
Heading 2
Body Text
Heading 3
Body Text
Page 2 of 18

Page 3 of 18

A GMP Organization
1 Organization, Qualification, and Responsibilities
The companys Quality System has been designed to ensure the provision
of safe, quality products to our customers.
The System has been built and implemented based upon the principles
and requirements of the current Good Manufacturing Practices (GMP)
issued by the Philippine FDA in the AO 153.
The company has established different departments to ensure the strict
implementation of these GMP guidelines as indicated in the organizational
chart (see SOP A 101 Organizational Chart).
The responsibilities of the different managerial and supervisory staff are
clearly defined (see SOP A-102 Job Descriptions).

2. Training
All our staff undergoes continuous training, which is regularly instituted,
updated and validated, in GMP and Food Safety and is qualified for their
job duties. The training and awareness process is documented in our
Training and Awareness Procedure (SOP A 201 Training and
Awareness).

Page 4 of 18

B Premises
1. Grounds
Our company is located in an area away from major pollutants. It is
constructed and maintained to protect it from contaminants.
Good housekeeping is applied according to our Maintenance of Premises
Procedure (SOP B 101 General Maintenance of Plant and Premises).
This is the same procedure as for preventive maintenance! (see 5.1 in AO
153 for General Maintenance)
List other measure you are taking to keep good your premises well
maintained!

2. Plant Construction and Design

Plant, building and structures are designed in a way to comply with the
requirement of the cGMP and to minimize the risk of cross contamination
that will affect the safety of the product.
The Companys Master Plan Diagram (see SOP B 201 Master plan )
provides an overview of relevant Food Safety issues:

Building outline with production areas, service areas and surroundings.

Process flow, workers flow, raw material flow.

Waste collection area, waste water drain off

Definition of areas in terms of hygiene zones and functions

Drinking water supply

List other relevant details!

Minimum design and constructions requirements of plant facilities are

fulfilled and our Company has used materials which are suitable for food
processing
Page 5 of 18

(see SOP B 202 Explanatory leaflet of materials used and techniques

of constructions employed).

Page 6 of 18

C. Equipment

All equipment used for food production is designed and constructed in a

way as to minimize cross-contamination during production and to facilitate
easy cleaning.
All material used for the construction of equipment is resistant to corrosion
and non-toxic. Details about the equipment used for production can be
seen in the companys Explanatory leaflet of the equipment and machines
(SOP C 101).

Possibly, this can also be called List of equipment

It is the companys policy to minimize all glass parts at equipment. If

equipment contains glass part it is indicated in the Glass Register (SOP
C 102).

All equipment is installed with adequate space from each other in order to
minimize cross-contamination as indicated in the companys Master Plan
Diagram (see SOP B 201 Master plan )

All equipment will be cleaned and maintained according to the companys

Maintenance, Cleaning and Sanitation Program (SOP D 501
Maintenance, Cleaning and Sanitation Program).

Page 7 of 18

D. Sanitation and Hygiene

1. Personnel
1.1. Disease Control

It is one of the companys policies that any personnel who is shown to

have, or appears to have, an illness, open lesion, including boils, sores, or
infected wounds, or any other possible source of microbial contamination
is excluded until the condition is corrected.
Prior to work every newly hired employee will undergo a medical check-up
to examine his/her health condition. Regular check-ups will be held
according to our Disease Control Procedures (SOP D 111)
Health certificates of each employee are required by the Management.
Comment: This can be stated in the SOP. Define where you will keep
these kinds of records.
Training is a good a way to show to the inspector that employee have
been made aware of Disease Control and Personal Hygiene.

1.2 Hygienic Practices

It is the companys policy that all personnel who handle food or are
involved in the food processing are obliged to act according to hygienic
practices while on duty to the extent necessary to protect against
contamination of food.

Adequate protective clothing will be provided by the company.

All employees must adhere to the companys policy in regard to hygienic
practices. (SOP D 121).
Please define what kind of procedures, records, etc you want to have to
show to the inspector that you comply with this clause:

Page 8 of 18

Pointers:
SOP D 121 Hygienic Practices Policy:
(Describe what protective clothing you want your employees to wear,
Describe handwashing procedures, Describe how you would supervise
that everybody follows the policy, Describe training, etc,)
2. Education and Training
All our staff undergoes continuous training, which is regularly instituted,
updated and validated, in GMP and Food Safety and is qualified for their
job duties. The training and awareness process is documented in our
Training and Awareness Procedure (SOP A 201 Training and
Awareness).

3. Supervision
Authority and responsibilities are clearly assigned according to the
companys organizational chart to ensure compliance (see DOC A 101
Organizational Chart).
The responsibilities of the different managerial and supervisory staff are
clearly defined (see SOP A-102 Job Descriptions).

4. Sanitary Facilities
The company provides all necessary sanitary facilities as follows:

List up what sanitary facilities you provide, e.g.:

Water supply you might use potable water for production and nonpotable water for other purposes. Describe it here!
Effluent and Waste diposal
Changing facilities
Toilets

Page 9 of 18

Handwashing Facilities
Disinfection facilities (only if you consider them necessary)
Facilities for storage of waste and inedible material
Eating facilities
Others

All these sanitary facilities are indicated in the companys Master Plan
Diagram (see SOP B 201 Master plan).
5. Maintenance and Sanitation
5.1 General Maintenance, Cleaning and Sanitation Program

The establishments and equipment of the company are regularly

maintained, cleaned and sanitized according to the companys
Maintenance, Cleaning and Sanitation Program (SOP D 511
Maintenance, Cleaning and Sanitation Program).
For the company good maintenance is a must/a prerequisite to ensure
and facilitate proper sanitation procedures and to prevent possible
contamination from metal shards, flaking plasters, debris and chemicals.

Employees responsible for maintenance, cleaning and sanitation are

appropriately trained on relevant fields regarding food safety according to
the companys Training and Awareness Procedure (SOP A 201
Training and Awareness).

5.2 Pest Control

All kind of animals are strictly excluded and prevented from all food
processing activities according to companys policies.

Measures such as e.g. wire mesh screens or electrocution traps taken by

the company in order to control pest and vermin within the premises.
Page 10 of 18

Additionally, the company contracts an external pest control company to

operate an effective pest control program in all relevant areas of the
company. (SOP D 521 Pest Control Program).

Page 11 of 18

E. Production and Process Controls

1. Production Processes and Controls
The process flow is designed in a way that all operations are conducted in
accordance to sanitation principles and guarantee Food safety of the
products.
A flow diagram is prepared and used as a basis for evaluating food safety
hazards. The accuracy of the diagrams is verified through on-site checking
by qualified personnel. (maybe also by the Food Safety Team if already
founded better!).
The flow diagram identifies the existing control measures, process
parameters or procedures that influence food safety as well as relevant
external requirements (SOP E 101 Flow Diagram and Process
Description).
(Consider: You might need more than one flow diagram to describe your
processes!)

1.1 Raw Materials and other Ingredients

Raw materials and other ingredients are inspected and controlled at the
receiving and must apply to the companys specifications (SOP E 1.1.1
Raw Material Specification List).

(You might also request the supplier for a letter of guarantee or certificate
of analysis this is an important Document! Consider this and specify!:
e.g. Suppliers are requested to submit a certificate of analysis for their
product, see DOC 1.1.2 List of COAs)

They are properly stored to protect against contamination and to minimize

deterioration (see SOP E 101 Flow Diagram and Process Description).

Page 12 of 18

1.2 Manufacturing Operations

All manufacturing operations necessary for the sanitary handling and

maintenance of equipment and utensils are established.
Equipment, utensils and finished food containers are maintained in a
sanitary condition according to the companys Maintenance, Cleaning and
Sanitation Program (SOP D 511 Maintenance, Cleaning and Sanitation
Program).

Physical factors important for the consistency, quality and safety of the
product are monitored (see SOP E 101 Flow Diagram and Process
Description).
Glass within the production is generally avoided. Where glassware or
glass parts are used, they are registered in the companys Glass register
(SOP C 102 Glass register).

Browse through clause 1.2 Manufacturing operations and decide which

clauses are relevant for your company and describe how you would deal
with them, maybe in the process flow diagram! Indicate relevant
Documents!

Page 13 of 18

F. Quality Control
1. Quality Management
The companys quality control system is established. It involves sampling,
inspecting of starting materials, in process, intermediate, bulk and finished
product.
Decide what kind of testing you want to establish in your company. Check
with the BFAD requirements (List of laboratory analysis for food
microbiology and food chemistry).
Consider quality as well as food safety issues!
Consider:
Review of batch Documentation
Sample retention program
Stability studies (if necessary)
Product complaints
Product recalls
Specifications of materials and products

2. Testing of Reprocessed Products and Testing of Returned Goods

If deviations at critical control points or control point occur, the company
will decide what actions will be taken to guarantee Food Safety of the
product (SOP F 201 Deviations Procedure).
In case of reprocessing the finished product will be tested again.
Additional testing of finished product will be performed if considered
necessary.
Returned goods are stored separately and tested if necessary. Any
returned products that do not comply with the original specification will be
rejected and disposed as described in the Deviations Procedure (SOP F
201 Deviations Procedure).

Page 14 of 18

Page 15 of 18

G. Documentation
The companys GMP-system is Documented in this GMP Manual,
Procedures, Work Instructions and Records.
The companys Document control process ensures that all GMP
Documents are controlled. All proposed changes are reviewed for their
effect on food safety, quality and consistency and approved before
implementation. This process is Documented in our Document Control
Procedure (SOP G 101 Control of Documents).
The procedure defines Document control including Document approval,
review, update and re-approval of Documents, identification of changes
and current revision, availability of current Documents at point of use,
legibility and identification of Documents, control of Documents of external
origin and prevention of unintended use of obsolete Documents.
The company controls records according to our Quality Records
Procedure. (SOP G 102 Control of Records)
This process addresses the steps required to establish and maintain our
records to demonstrate the companys conformance to GMP requirements
as well as regulatory requirements. The procedure defines identification,
storage, protection, retrieval, retention time, and disposition methods.

Page 16 of 18

H. Quality Audits
Internal audits are conducted to verify the effectiveness of the GMP
system. Audits determine whether the system conforms to the
requirements
An Internal Audit procedure describes the audit process, responsibilities
and authorities (SOP H 101 Internal Audit Procedure)
The procedure defines the criteria, scope, frequency and methods used
for the audit process. A report will be made at the completion of each
quality audit.

I. Warehousing and Distribution

The company has established procedures for sanitary handling of food on
storage and distribution in order to protect the product against physical,
chemical and microbial contamination as well as against deterioration of
the food and the container.
The companys Warehousing and Distributions Procedure describes the
sanitary handling of the product considering (SOP I 101 Warehousing
and Distribution Procedure):
-

Stock rotation (FIFO, FEFO)

Separate storage of goods from chemicals, potentially contaminated

incoming materials, defective stock, market returns or complaint goods

Security and tidiness of storage facilities

J. Product Recall
All quality or safety-related complaints, whether received orally of in
writing, are recorded and investigated by the company.

Page 17 of 18

After evaluation corrective actions are taken according to the companys

Customer Complaints Handling Procedure (SOP J 101 Customer
Complaints Handling Procedure).
Actions are taken to prevent any nonconforming product from entering the
food chain unless it has been determined that the food safety hazard has
been reduced to stated acceptable levels or will be before entering the
food chain or that the product meets acceptable levels despite of the
nonconformity.
All lots of product that may have been affected by non-conformity are held
under control until they have been evaluated. If any product has left
control of The Company a recall is initiated according to Product Recall
Procedure (SOP J 102 Product Recall Procedure).

K. Retention of Samples
Retention Samples are withdrawn from the production as described in
SOP E 101 Flow Diagram and Process Description

L. Sub-Contracting of Manufacture
The conditions of contract manufacturing (if any) will be defined, agreed
and controlled.
Relevant Documents are kept.

Pointer: This clause might be not relevant for your company but maybe
you have a contracted pest control company.

Page 18 of 18