External Audit (Mock Inspection)
Whether a new or existing WDA (H) holder, a fresh set of eyes is always helpful. Our External Audit Team can provide a full audit of your current processes, procedures and records against the current Guidelines of 5 November 2013 on Good Distribution Practice (GDP) of Medicinal Products for Human Use (2013/C 343/01).
By doing this any potential non-conformities, that could affect the quality of products or the outcome of your next MHRA inspection and GDP Compliance, are identified. The number and seriousness of non-conformities found during an inspection determine the information shown on your GDP Compliance Certificate and the frequency of your inspections.
Should any non-conformities be identified during our audits, we can also assist you with root cause analysis and corrective action identification, planning and implementation.
Why Consider Us for your GDP External Audit (Mock Inspection)?
All of our Consultants are registered RPs with MHRA and also consists of certified ISO Lead Auditors who have been involved in many compliance inspections/audits.
Our pre-inspection audits have enabled clients to reduce the number and seriousness of non-conformities and achieve good inspection outcomes.
We have also been able to advise clients on the improvement of processes and procedures across the organisation, streamlining and improving processes and the resources required to carry them out. Our audits also prepare personnel for external, compliancy, audits.
For further information contact us.
Please click on the links below to view full details of each case study.
Pharmacy Consulting have provided our business with excellent support, advice and training with regard to obtaining Wholesale Dealers Authorisation following the implementation of European Commission Guidelines of 5 November 2013 on Good Distribution Practice, 2013/C 343/01. I would like to personally thank Dawn and her team for her personal assistance in securing the authorisation.
Since 2012 we have been using PCL for regulatory support, staff resourcing, training and general advice. We have consistently found that the whole team has a high level of technical competence, are always willing to get stuck in to help us and are able to come up with robust ideas to improve our systems. I would have no hesitation in recommending their services in any of these areas.
The training was delivered in a relaxed and friendly atmosphere. The elements of the training were explained in a clear and concise manner and the course was tailored around your individual requirements. The day was enjoyable and I would not hesitate to use your company again. Tracy Tollervey from CPG – Logistic.
Dawn ran a very informative session about GDP guidance and the role of the Responsible Person. This helped me understand further about my role as the Responsible Person and how to stay 100% compliant according to the guidelines. I also picked up key points on what to look for when looking at potential suppliers and warehouse facilities. All together an excellent session, worth every penny! Pharmaceutical Wholesaler Client
Pharmacy Consulting have provided us with a prompt and professional service, including advice, GDP training and helping us with a robust customised Quality System. During this time they have been committed to fully understanding our company needs and have consistently delivered excellent service. I would highly recommend PCL to any business for peace of mind and sound professional advice. Ben Funnell Director Universal PS
Jackie has proved to be a very knowledgeable and professional recruitment consultant, All communications have been very professional and I would not hesitate to recommend Jackie.
I have really enjoyed the training. Zul is a very good communicator and very approachable. 🙂
Just wanted to say thank you for the training last week, was education and fun, and it was great to be able to spend time with a professional auditor.
Pharmacy Consulting provided us with a very professional and efficient service over a number of extremely busy months. Not only were they flexible to our requirements but also to our workloads, time schedules and finances. Jackie Peck in particular was extremely aware of our needs and outcome requirements. For a small company such as ourselves this was invaluable. At all times Pharmacy Consulting kept us informed of any amendments, changes, monetary matters and as the client we felt it was a very professional service. The intended outcome was successfully achieved and the team at Pharmacy Consulting went above and beyond their duties as consultants for us. I cannot recommend them enough.
Pharmacy Consulting has been performing consultancy work for Vygon for several years, during that time they have provided us with a very professional and efficient service. PCL helped Vygon obtain their original Wholesale Dealers Licence and have provided Responsible Person (RP) support to our Quality Team ever since. PCL guided us successfully through our MHRA inspection. More recently, Jackie delivered GDP update training sessions for me and my deputy when I started in my new role as Head of QA/RA. I would recommend PCL to any organisation that needs support in their pharmaceutical operations. Vicky Muir QA/RA Manager Vygon