Good Manufacturing Practice/Good Distribution Practice
According to the Control of Drugs and Cosmetics Regulations 1984, complaince to Good Manufacturing Practice is a pre-quisite for the application of a manufacturing license as well as product registration/ cosmetic notification.
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, efficious and of quality.
Centre for Compliance and Licensing (CCL) is responsible for the Good Manufacturing Practice (GMP) inspections of manufacturers of registered products and notified cosmetics to ensure manufacturers compliance towards the current GMP requirements. CCL, with the assistance of the State Pharmacy Enforcement Division, is responsible for ensuring the importers and wholesalers of registered products adhere to the current Good Distribution Practice (GDP) requirements.
GMP guidelines are as below:
| Guidelines | Product Type / Category |
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
| Pharmaceuticals (Poison and Non-Poison) Veterinary Medicinal Products |
GMP Guideline for Traditional Medicines and Health Supplements
| Traditional Products Health Supplements |
| Guidelines on Good Manufacturing Practice (GMP) for Cosmetic (Annex 1, Part 9) | Cosmetics |
| Guidelines on Good Manufacturing Practice (GMP) for Veterinary Premixes | Veterinary Premixes |
| Guidelines on Good Distribution Practice (GDP) | For activities related to the storage and distribution by manufacturers, importers and wholesalers (where applicable) |
Refer to FAQ: GMP/GDP and Guideline Central Inspection section for further enquiries.
GMP Certificate
GMP certificates are issued for the purpose of exportation of locally manufactured registered products. It endorses that the local manufacturer complies with the current GMP requirements. These certificates are required by the overseas regulatory agencies for products registration in their countries. Thus when filling in the GMP certificate application form, the correct address of overseas regulatory agencies given by the companies is crucial.
For those companies interested to apply GMP certificate, company can download Borang Permohonan Sijil APB (BPFK-420)
No comments:
Post a Comment