Good Manufacturing

Practices (GMP)
Accreditation
Group Members:
Tan Kee Phang 141141214
Lai Gek Yan 141141165
Chong Sook Woon 141141154
Phua Fong Yee 141141206
 • A part of Quality Assurance (QA)
• Ensures the production consistency
GMP
• Controls product quality according to quality
standard appropriate to the intended use

Why should a production plant implement

GMP?
The implementation of GMP aimed primarily to
diminish the risks such as cross contamination/mix-
ups and false labelling in any production.
Is obtaining GMP a must?
• According to the Control of Drugs and Cosmetics
Regulations 1984, compliance to Good
Manufacturing Practice is a prerequisite for the
application of a manufacturing license as well as
product registration/ cosmetic notification.
 GMP guidelines according to respective product
categories:
Product Type / Category Guidelines
Pharmaceuticals (Poison and Non-Poison) PIC/S Guide to Good Manufacturing
Veterinary Medicinal Products Practice for Medicinal Products
https://www.picscheme.org/
Traditional Products Health Supplements GMP Guideline for Traditional Medicines
and Health Supplements
Cosmetics Guidelines on Good Manufacturing
Practice (GMP) for Cosmetic (Annex 1,
Part 9)
Veterinary Premixes Guidelines on Good Manufacturing
Practice (GMP) for Veterinary Premixes
For activities related to the storage and Guidelines on Good Distribution Practice
distribution by manufacturers, importers (GDP)
and wholesalers (where applicable)
Accreditation in GMP certification can
be applied through:

• SIRIM QAS • SGS (A world leader in third

INTERNATIONAL party certification and
verification)
Several guidelines outlining the GMP requirements:
1) Design and layout of premises

2) Supplies of water, air and energy

3) Management of waste

4) Equipment suitability and preventive maintenance

5) Cleaning and sanitation

6) Management of purchased materials

7) Pest control

8) Prevention of cross contamination

9) Personal Hygiene
 Overall Process of GMP Certification
Verification on
Submission of Recommendation
initial
corrective
to Certification
questionnaire actions on non
Panel
conformities

Contract Review Approval by the

and Preparation Stage 2 Audit Certification
of Quotation Panel

Award of
certificate with
Application Stage 1 Audit validity of 3
years
 GMP Certification Process Description
Submission of Initial Questionnaire
• The applicant completes and submits the initial questionnaire to the
accreditation bodies

Contract Review and Preparation of Quotation

• The accreditation bodies will review information in the Initial
Questionnaire and prepare a quotation on the total cost of certification.
The quotation provides estimation costs for certification that includes
application fee, professional fee for stage 1 and stage 2 audits and
related incidental costs. Overall certification costs are calculated based
on the number of auditor days required to conduct the audit.

Application
• Upon agreeing to the quotation, the applicant is required to submit the
application form together with application fees.
GMP Certification Process Description

GMP Application
Form Sample
GMP Application Form Sample
 GMP Certification Process Description
Stage 1 Audit
• Upon receipt of the application form, the accreditation bodies will appoint
an Auditor. Stage 1 Auditor is carried out on site to determine
(1) the adequacy of the applicant’s documentation
(2) whether an internal audit and management review have been
conducted
(3) the readiness of the applicant to proceed to stage 2 audit
(4) identify any areas of concern that could be classified as
nonconformity shall be resolved before stage 2 audit
Stage 2 Audit
• After the findings of the Stage 1 Audit has been resolved, the applicant
inform the Audit Team Leader on the readiness to proceed to Stage 2
Audit. During this stage, the audit team will evaluate the implementation
including the effectiveness of the applicant’s GMP systems and
practices against the requirements of the relevant standards.
 GMP Certification Process Description
Findings from Stage 2 Audit
• Audit findings of Stage 2 shall be classified as either major and minor
nonconformities and opportunities for improvements.

Recommendations to the Certification Panel

• Upon satisfaction verification and resolution of the non conformities
raised, recommendation will be made to the Certification Panel to be
awarded with GMP certification.

Issuance of Certificate
• The certification shall be issued upon payment of all fees due and
signing of Certification Agreement. The certification is valid for 3 years.
Types of Audit
Surveillance Audit
• All certified clients shall be subjected to one annual
surveillance audit. The first surveillance audit shall
be conducted not more than 12 months from Stage 2
Audit

Recertification Audit
• Recertification is carried out every 3 years prior to
expiry
Scope of Accreditation
Category Categories
Codes
C processing 1 (perishable
animal products) including
all activities after farming
Eg. slaughtering, milking
D processing 2 (perishable
vegetal products) including
minimally processed
products
Sector (Examples)
- Manufacture of meat, poultry, fish, crustaceans
and molluscs based products
Eg. bakery products, sandwiches
- Manufacture of dairy products
- Manufacture of fruits and vegetables based
products
Eg. bakery products, sandwiches, salads, cut fruits
and vegetables
- Wholesale and retail sale of food and traders of
food including repacking of food
Scope of Accreditation
Category Categories Sector (Examples)
Codes

E processing 3 (products - Manufacture of vegetable and animal oils and fats

with long shelf life at - Manufacture of beverages including soft drinks,
specified temperatures) mineral waters and other bottled waters
- Manufacture of edible birds nest and products

F catering including Preparation and serving of meals and dishes including

mobile food service beverages, including all related activities. Eg. event
activities, hotel and catering, holiday and short stay accommodation,
related activities camping grounds, recreational vehicles parks and trailer
parks, satellite or central kitchens, in flight kitchens
restaurants, hostels, canteen
repacking of food
Scope of Accreditation
Category Categories Sector (Examples)
Codes

G food additives and - Manufacture of food additives, vitamins, biocultures

supplements - Wholesale and retail sale of food and traders of food
including repacking of food