On the 12th August, 2014 the MHRA issued an e-mail stating their concerns that a significant number of major deficiencies are being identified where wholesalers have not read, understood or implemented the revised EU Guidelines on Good Distribution Practice. The message came with a warning that failure to comply with current GDP is likely to result in a number of major deficiencies at the next inspection and that the number of deficiencies received will affect an organisation’s risk rating and will lead to more frequent inspections.
These Guidelines came into force on the 8th September, 2014.
During audits of WDA holder sites, there are a couple of main indicators that we look for when checking if the organisation is aware of and compliant to current GDP. A great indicator is the last review and amendment date on the quality system documents, if there has been no review or amendments for two years or more, it is a guarantee that the additional requirements have not been considered and incorporated into the organisation’s processes and procedures. Another indicator is the organisation’s knowledge of falsified medicines and what they do to prevent them being received and sold on.
Was your quality system reviewed and updated to meet the requirements of the revised GDP Guidelines? Are you and your staff aware of the revised GDP and the Falsified Medicines Directive? If you answer no to these questions, you will need to take action now!
PCL can help you to achieve compliance in several ways by offering:
GDP Training – A detailed look at the guidance and its clauses – how to comply.
Audit and gap analysis of your current systems to identify what your organisation needs to do in order to achieve compliance. Assistance with updating your quality system (SOPs & associated documents & records), implementation and training.
For help with achieving compliance with the revised guidelines, give us a call on 01252 302342