Good Distribution Practice
Good Distribution Practice (GDP) refers to the regulatory guidelines governing the wholesale distribution of medicinal products to ensure their quality and integrity is maintained throughout the supply chain from the manufacturer to the end user.
Good Distribution Practice extends beyond the distribution of the finished product and includes the sourcing, storage and transportation of APIs and other ingredients prior to manufacturing.
Failure to adhere to the guidelines at any point within the supply chain, including all intermediate points of storage and transport, can have a serious impact on the quality of the product.
Is Good Distribution Practice (GDP) essential?
The implementation of Good Distribution Practice is of paramount importance to patient safety as the global supply chain is becoming complex and fragmented.
The WHO (2010) defines Good Distribution Practice as
an essential tool to secure the distribution system from counterfeits, unapproved, illegally imported, stolen, counterfeit, substandard, adulterated, and/or misbranded pharmaceutical products
This is echoed in the latest EU guidelines which were published in 2013:
These Guidelines lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain. Compliance with these Guidelines will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products.
Anyone involved in the wholesale supply of human medicines is required to hold a valid Wholesale Distribution Authorisation (WDA) and comply with the latest Guidelines published in 2013 on the Good Distribution Practice (GDP) for medicines.
How Pharma Experts can help
Our team of experts is ready to assist you in achieving compliance with the Good Distribution Guidelines including:
- Quality Systems
- Contracted RP
- Warehouse design and layout
- Temperature Mapping
- Complaints, Recalls and Falsified Medicines
- Technical Agreements for Outsourced Activities
- Pre-inspection Audits
- Transportation and Packaging Validation
The above list is not exhaustive and if you have any specific requirements please contact us for a prompt response.
Are you Ready for your Inspection?
At Pharma Expert we believe all business should be ready for inspection at all times.
In our experience, receipt of a letter from the MHRA announcing a date for inspection causes untold levels of stress and disruption as businesses get caught due to self-inflicted unpreparedness.
Are you complying with the latest Good Distribution Guidelines?
Are you ready for an unannounced MHRA inspection?
Our Pre-inspection Audit is designed from an inspectors perspective and identifies areas which need improvement.
Don leave it too late!
If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation please contact our office and send us your request, or schedule a free initial telephone consultation.