WHO-GDP
- • GDP certificates and statements of non-compliance may be issued to wholesale distributors of medicinal products and distributors of active substances."
- • What is GPD certificate?
- - Good distribution practices (GDP) certification requires pharmaceutical product handlers to meet stringent World Health Organization (WHO) standards for safety and security. While GDP certification is not a global requirement, EU pharmaceutical companies and their logistics partners must comply with GDP regulations.
- - 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.
- - 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.
- Typical GDP Standards
- • EU GDP Guidelines (2013/C 343/01)
- • United States Pharmacopeia (USP 1079), and
- • WHO GDP (World Health Organization TRS 957 Annex 5)
- - As a trusted partner, we provide a comprehensive set of solutions that touch all parts of the pharmaceutical supply chain. TMC provides expertise in quality and safety management, and Good Distribution Practices (GDP). We deliver consulting, certification and training solutions across a global network, giving you the knowledge to decipher the complexity and breadth of today's regulatory environment in a consistent manner.
- World Health Organization (WHO) GDP certification provides helps you:
- • Identify GDP specifications
- • Recognize deficiencies before regulators or funders carry out inspections
- • Ensure drugs are manufactured in compliance with WHO GDP regulations and requirements
