New Good Distribution Practice (GDP) guidelines ( 2013/C 68/01) require Responsible Persons (RP) to be trained and to keep ” Up to date”. They require RPs to ensure that all their staff have a good understanding of the current GDP guidelines and are competent to carry out their role. Your Quality Management Systems have to be fit for purpose , controlled and updated using change and risk management principals . Do you and your team know what that means? Can you answer confidently when asked to describe your QMS and what is your process for updating it ?
Are you a RP for your company or for another company? Have you ever had any training ? Would you like to have some training? If yes would you like” Face to face” , tutorial group learning , U Tube style videos , webinars, or e learning ?
I was contacted by a pharmacist who had bought a pharmacy with a wholesale dealers licence this week, and who had been inspected by the MHRA and told his ” SOPs” were out of date and not fit for purpose, the inspector took pitty on him as he had just bought the business and gave him a chance to set up a QMS. He borrowed some SOPs from a ” Mate ” and called the inspector back ! The inspector told him once again that his SOPs were not fit for purpose. Pharmacy Consulting offered to write some SOPs for him and to provide a Contract RP service for him to which he replied …..” I will remain the RP as I have been a pharmacist for 20 years ! ” I want to raise the issue because we are finding that just because somebody is a competent pharmacist it does not mean that they are familiar with the nuances of GDP or the development and maintenance of a robust QMS. To maintain the Wholesale Licence or Wholesale Dealers Authorisation as it is called now requires both time and effort either by means of self learning or formal training, in addition it requires dedication and commitment to ensure it remains fit for purpose .
If you have not signed up to the next MHRA conference you have sadly missed the boat as it is over subscribed for the December 2013 dates !
Pharmacy Consulting run training events every month and will be launching new dates for 2014 shortly. We are going to run:
- “RP Responsible Person Update training”
- ” Root Cause Analysis”
- “GDP Good Distribution Practice Guidelines
- Cold Chain storage and transportation Validation
- Audit
If you would like to have some bespoke training designed for you or your team we are happy to work with you to meet your specific needs . If you are too busy to train your staff or just want a refresher course one of our team will be happy to help or to suggest the best course and the next available dates.
Pharmacy consulting have just been through a few client inspections and the inspector did focus on training and also looked at the training records for the staff. We were asked who had audit experience in the team and what did we know about change management and risk assessments.
Pharmacy Consulting are also very keen to set up some local RP networking events. Jackie and Antony would very much like to hear from you regarding topics you would like us to include to our new program and also which location suits you best ? London , Birmingham , Leeds, Stirling or our office in Farnborough. Please get in touch with Jackie or Antony at Pharmacy Consulting new office number +441252 302 342 or e mail [email protected] with comments or questions. Help us to help you…