BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN
Good Manufacturing Practice Guidelines NATIONAL PHARMACEUTICAL CONTROL BUREAU
Every manufacturer of registered products and notified KEMENTERIAN KESIHATAN MALAYSIA
MINISTRY OF HEALTH MALAYSIA
cosmetics will be inspected based on requirements set
by:
Type of Product GMP guideline
Pharmaceuticals PIC/S Guide to Good Manufacturing
(Poison & Practice for Medicinal Products
Non-Poison) www.picscheme.org
Veterinary PIC/S Guide to Good Manufacturing
GOOD
Practice for Medicinal Products
www.picscheme.org
Supplementary Guidelines on GMP for For further information, please contact::
Veterinary Premixes, Supplements and Centre for Compliance and Licensing
MANUFACTURING
Herbal/ Natural Preparations, 1st Edition, 1 National Pharmaceutical Control Bureau
January 2012
www.bpfk.gov.my Lot 36, Jalan Universiti,
46350 Petaling Jaya, Selangor.
PRACTICE
Traditional Guidelines On Good Manufacturing
Practice For Traditional Medicines And Tel: 03 7883 5565
Health Supplements, 1st Edition 2008 Fax: 03 7957 1200
www.bpfk.gov.my
Webpage: http://www.bpfk.gov.my
Guidelines On Good Manufacturing
Health
Practice For Traditional Medicines And
Supplements
Health Supplements, 1st Edition 2008
www.bpfk.gov.my
SIRIM
Cosmetics Annex 1, Part 9: ASEAN Guidelines for Certified to ISO 9001:2008 WHO Collaborating Centre for Regulatory
Control of Pharmaceuticals
Member of Pharmaceutical
Inspection Cooperation Scheme
Cert. No. : AR 2293
Cosmetic Good Manufacturing Practice,
Guideline for Control of Cosmetic Products
in Malaysia, May 2009, Rev.02
www.bpfk.gov.my
Note:
Guidelines on Good Distribution Practice (GDP); 1st
Edition 2011 (Source: www.bpfk.gov.my) is used for the
inspection of distribution and storage during a GMP
inspection.
GOOD MANUFACTURING PRACTICE APPLICATION PROCESS FOR PREMIS LAYOUT
EVALUATION, NEW MANUFACTURING PLANT
Under the Control of Drugs and Cosmetics Regulations INSPECTION AND LICENSING
1984, compliance to Good Manufacturing Practice is
required as one of the requirements to obtain the
Manufacturing License and to register products / notify Start
cosmetics. Plant layout submission by the
applicant
Good Manufacturing Practice (GMP) is a standard that Evaluation by evaluator
should be complied by manufacturers of registered
pharmaceuticals / traditionals and notified cosmetics
in order to ensure the safety, quality and efficacy of the Plant layout Contact applicant for
products manufactured. SATISFACTORY?
NO
further Information
Registration of Product
YES
Manufacturing can be defined as: NO
Table the plant layout in CCL
Internal Meeting
The making or assembling of the product.
Products registered?
Issuance of evaluation letter to
applicant YES
The enclosing or packing of the product in any
container in a form suitable for administration or Facility renovation / preparation
Submission of application for
Manufacturer’s License
application, and the labeling of the container.
Once ready, applicant to send an Evaluation
Invitation for GMP Inspection
The carrying out of any process in the course of any NO
of the foregoing activities Conduct the Inspection
NO Complete?
YES
Preparation of Approval List
GMP Compliance
SATISFACTORY?
Approval by Director of
Pharmaceutical Services
YES
Table In JKPPP Meeting Issuance of Letter of
Confirmation (LOC) Printing of Manufacturer’s License
and Products List
Issuance of License
Manufacturer has the
Manufacturer’s License to
manufacture registered products
Schedule for routine Inspection
based on frequency set
Annual renewal of Manufacturer’s
License
