GDP Compliance-Good Distribution Practice




Good Distribution Practice (GDP) is that part of quality assurance which ensures products are consistently stored, transported and handled under suitable conditions as required by the marketing authorisation (MA) or product specification.

Good Distribution Practices (GDP) is a quality system for warehouse and distribution centers dedicated for medicines. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards. The scheme ensures that consistent quality management systems are in place throughout your entire supply chain, from the early delivery of raw materials to the manufacturing plants, to the final shipment of finished drugs to the end user. An independent assessment of compliance against international GDP requirements is the most effective way to establish that your quality management system aligns with GDP guidance.

The GDP Guideline will apply not only to the wholesalers and manufacturers of pharmaceuticals, it also incorporates the specific requirements for the Brokers dealing with pharmaceutical products. The responsibility for the product during storage and distribution will remain with the manufacturers up to the point of sale, where wholesale dealers will take ownership of the products.

It is clear that those playing a role in the pharmaceutical supply chain must comply with these requirements, therefore the service providers such as transportation companies, the logistic service providers need to gain good understanding of what is required to be able to provide appropriate service to their clients. The structure of the final document has been aligned with the structure of the GMP Guidelines, now including 10 chapters:

  1. Quality Management.
  2. Personnel
  3. Premises and Equipment
  4. Documentation
  5. Operations
  6. Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
  7. Outsourced Activities
  8. Self-Inspections
  9. Transportation
  10. Specific Provisions for Brokers