All the wholesale distributors acting in the EU must maintain a quality setting out of responsibility, processes and risk management relating with their business following the last reviewed guidelines.
The new Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/1) are based on 10 chapters. They have been implemented to guide wholesale distributors in conducting their activities in a compliant way which prevents falsified medicine and maintains product integrity. Ultimately protecting the patients.
The application or variation of a Wholesale Distribution Authorisation for the administration, storage, handling and distribution of licenced medicines needs to be made from the MHRA Portal.
After conducting a GAP analysis, you need to create solid and robust quality system in regards to your activities.
A key part during this process is to write up your Standard Procedure Operations in line with your activities. Sounds easy, think again…
Disaster plan, Transport Validation Master Plan, Audit, Bona Fide Checking, Mock Inspection, Temperature Mapping, Action Plan…..and more.
Have you considered any of these?
Do they ring a bell?
If you have any concerns about whether or not your service is meeting the Guidelines call us on 01252 302342 and one of our team will be happy to advise you.