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.

Case Studies

Please click on the links below to view full details of each case study.

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.    
Testimonial From Integro Pharmacy - David Hammond