WHO GDP Audit in Hyderabad

Listing ID #6586728

CDG Provides WHO GDP certification services in Hyderabad.

What is Good Distribution Practice?

Good distribution practice is a set of standards for the sourcing, handling, storage, and transportation of medicines for human use and their active ingredients. Wholesale licence and authorisation holders must comply with good distribution practice to ensure the quality, safety, and security of medicinal products throughout the pharmaceutical supply chain.

Why is Good Distribution Practice Important?

Good distribution practice is important because it greatly affects public health. Any mistake in distribution can cause shortages, delays, and even the introduction of falsified medicines into the market.

Another reason why GDP is important in pharma is that it aids in product traceability, which can be a huge factor during official investigations of quality issues or incidents involving pharmaceutical products.

Overall, following good distribution practices protects wholesale distributors from situations that would not only damage their reputation in the industry but also harm the general public and lead to a huge loss in customers.

Who Needs GDP Certification?

According to the European Medicines Agency, all wholesale distributors of medicines in the European Economic Area (EEA) need GDP certification. Similarly in the UK, anyone that intends to sell or supply medicines to someone other than the end-user needs GDP certification.

In the European Union (EU), a GDP certificate is issued by the competent authority when the inspection has officially ended or 90 days since the last day of the inspection, provided that nearly all areas are GDP compliant. 

Good distribution practice in the UK is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). Unlike in the EU, the GDP certificate is only given when the MHRA inspector accepts the distributor’s response to the post-inspection letter.

GDP Guidelines or Principles of Good Distribution Practice

• Quality System/Quality Management-A quality system should have the organizational structure, procedures, processes, resources, and actions needed to demonstrate that the distributor meets quality requirements. Quality management or the quality system must include a documented quality policy as well as authorized procurement and release procedures.
• Personnel-Management must appoint a responsible person whose duties include all the activities necessary for GDP compliance, such as implementing and maintaining the quality system.
• Supplier & Customer Qualification-Wholesalers need to check if a potential supplier has a wholesale distribution authorisation or a wholesale dealer licence before selecting them.
• Storage-In general, warehouses should be clean, dry, and free from vermin. The temperature and humidity levels in storage areas should be within acceptable ranges
• Transportation-Before dispatch, the wholesaler must first confirm that the delivery order is valid or that there is a documented material replenishment plan for the customer. After confirmation, the medicines are to be placed in a shipping container with a label that describes the handling and storage requirements and precautions, as well as the contents of the container and its source.
• Documentation-Documentation should be sufficient enough to enable complete traceability of medicinal products across distribution channels. All parties involved have to be readily identifiable.
• Self-Inspections-A key requirement of good distribution practice is a self-inspection programme. The scope of self-inspections can vary. The wholesaler may decide that a comprehensive self-inspection performed less often is better than smaller, more specific self-inspections performed regularly.