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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

    https://www.picscheme.org/

    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 toFAQ: GMP/GDP andGuideline 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)

     

    Other News & Important Announcements

    Pembayaran Caj Pemeriksaan Amalan Perkilangan Baik (APB) yang Dijalankan oleh BPFK Ke Atas Pengilang Tradisional & Kosmetik Secara Pra-Bayar (PDF)
    Borang Permohonan Pemeriksaan Amalan Perkilangan Baik (APB) Bukan Rutin Bagi Pengilang Tradisional dan Kosmetik (PDF)

     

     

    Updated : 14 May 2013



  • The National Pharmaceutical Regulatory Division (NPRA) has implemented Cold Chain Inspection (CCI) to be carried out on every batch of registered vaccines and plasma products imported to Malaysia alongside with the implementation of Lot Release Activity since January 2015 and July 2016 respectively. Effectively on 2nd October 2017, NPRA will be implementing a new work process of cold chain inspection as part of the improvement on the existing cold chain inspection process flow.




    No Dokumen  Download
    1 Guidance Notes For Completing The Vaccine Arrival Report (VAR) / Plasma Product Arrival Report (PPAR)   Download
    2 Vaccine / Plasma Product Arrival Report   Download


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