As I have mentioned before the EU are currently consulting on updating the Good Distribution Practice guidelines across Europe. Having attended an MHRA training day in London recently, it is evident to me that there are a several areas where Wholesale Dealers and their Responsible Persons will have to soon commence work in order to remain fully compliant with the expected new regulations.
One improvement area is that all Wholesale dealers will be expected to put in place a formal quality system. This does not necessarily mean that a quality accreditation (like for example ISO certification) will be required, but it does mean that at the least a quality manual will need to be developed and SOPs reviewed to ensure that they embody quality principles such as for example CAPA
Another area of expected improvement is that Responsible Persons will have to have a job description, and regularly receive and record their own GDP training (even if they are already experienced). The MHRA are understood to already be tendering for 3rd party companies to undertake such training.
Of note is an expectation that Wholesalers will identify what qualification or validation work is necessary to control the key aspects of their business, via a documented risk assessment approach. Validation activities will need to be planned and documented and the improvement plan should specify acceptance criteria.
Whilst the consultation is not expected to require immediate changes in early 2012, it would not be sensible to leave the required work to the last minute before the new regulations come into force.