WHAT IS GOOD MANUFACTURING PRACTICE (GMP)?

Good Manufacturing Practice (GMP) is a standard that should be followed by manufacturers of registered pharmaceutical/traditional products and notified cosmetics to ensure that the product manufactured is safe, efficacious and of quality. Compliance to Good Manufacturing Practice is a pre-requisite for the application of a manufacturing license, as well as product registration/cosmetic notification.

AUDITORS

Centre for Compliance and Licensing (CCL),National Pharmaceutical Control Bureau (NPCB), Ministry of Health Malaysia.

PRE-REQUISITE

a) Each manufacturer interested to manufacture registered products is required to comply with GMP requirements. There is no specific application form to request for an inspection to be conducted. However, prior to licensing, an official invitation letter may be addressed to the CCL to request for a pre-licensing inspection.

b) Manufacturers of registered products or notified cosmetics found to comply with current GMP requirements during the pre-licensing inspection will be subjected to routine inspections thereafter.

MANUFACTURING REQUIREMENT

Under the Control of Drugs and Cosmetics Regulations 1984, all registered products and notified cosmetics are to be manufactured within GMP compliant premises. Factory may either be built by the company or to appoint a GMP compliant contract manufacturer.

THE LEVELS OF GMP COMPLIANCE

GMP compliance is rated as Good, Satisfactory or Poor. The level of compliance is determined by the weaknesses/non-conformances found during an inspection.

INSPECTION SCHEDULE

The frequency for inspection is determined according to the level of risk of the product manufactured, as well as the latest GMP compliance rating.

PROCEDURE OF INSPECTION

a) Prior to an inspection, an officer is appointed as the lead inspector and will determine the date of inspection, as well as a proposed inspection plan.

b) An inspection is preceded by an Opening Meeting, during which the objective, related guidelines, scope and inspection areas will be explained.

c) After the Opening Meeting, the inspection of the manufacturing premises, store premises, laboratory and documentation system shall commence.

d) At the end of the inspection, the lead inspector (and other accompanying inspectors) will present important inspection findings during a Closing Meeting. The GMP compliance status will either be announced during the Closing Meeting or further discussed in the Premises Inspection Evaluation Committee Meeting for the final decision.

POST INSPECTION

A Good Manufacturing Practice (GMP) Inspection Report will be prepared after each inspection is conducted. The manufacturer is expected to provide feedback regarding corrective and preventive actions taken towards each reported finding.

NON-COMPIANCE FINDINGS

New product registration applications will be rejected until GMP compliance is found to be satisfactory. Product registration renewals will not be allowed until GMP compliance is found to be satisfactory. The manufacturing license may be revoked by the Director of Pharmaceutical Services, according to Regulation 17(1) of the Control of Drugs and Cosmetics Regulations 1984.