Good Distribution Practice (GDP) Services in Malaysia

GDP Services

What is Good Distribution Practice (GDP)?

Good Distribution Practice (GDP) is a set of guidelines and practices that ensure the quality and integrity of pharmaceutical products throughout the entire distribution process. The main objective of GDP is to establish and maintain a system to control and document the various activities involved in the distribution of pharmaceutical products, with the ultimate goal of safeguarding public health.

Good Distribution Practice (GDP)

GDP is for activities relating to the wholesale handling, storage and distribution of pharmaceuticals, traditional medicines, health supplements and cosmetics. The GDP guidelines cover areas such as licensing, organisation and management, personnel, premises and facilities, documentation, operations, complaints and recalls, transportation and distribution records. A GDP system helps to preserve the quality, safety and efficacy of products along the supply chain and ensures medicines are delivered to the correct recipients. It also provides traceability in the event of problems such as a recall.

How to Implement GDP?

In Malaysia, manufacturers, importers and wholesalers of pharmaceutical products are subject to GDP regulations. These regulations are governed by the National Pharmaceutical Regulatory Agency (NPRA).

  • Understand the requirements for GDP
  • Develop and implement a QMS for GDP
  • Conduct a self inspection
  • Have NPRA conduct a GDP Inspection

How We can Help

We provide you with training and a tailored, practical GDP quality management system; after its implementation, we conduct an internal audit and support you through the NPRA GDP Inspection. Our  team of experienced professionals have the necessary expert knowledge to guide and assist you. Appointing the right consultant is key to your success with a GDP QMS. Get in touch!

Malaysia Consulting Services for GDP

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