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.
Very impressed, covered the majority of topics.James Weston – Orderline
“Great Presentation, very informative.”Roshni Rutton-Patel – Course Rating 10/10
We contracted PCL provide us with help and guidance and training, relating to pharmaceutical transportation, we found Jackie and her team to be helpful, knowledgeable and pragmatic in their advice. The training sessions went well and were very useful in helping us understand the subject. We looked long and hard for an industry expert in this field and we certainly found one in PCL. Andrew FoxDX (Group) plc
Very good overview of GDP requirements which has given me a much better understanding of client requirements for the services and products we supply.Isatec on site training – Bill Castle
“Very Informative course. I have learnt a lot of new information and the training was given in a relaxed environment. Thank you for making the learning as interesting as possible.”Megan – Course Rating 10/10
Lots of information and keeps you engaged.Isatec on site training – Abbey Tullett
“Very Informative. Great handouts to take away. Thanks”Megan – Course Rating 10/10
“Course was very informative and taught/explained very well.”Craig – Course Rating 9/10
“Really well presented and explained. Have a much better understanding of a very involved subject.”Vicky Stones 10/10
” Very interesting presentation which allowed me to gain a proper overview of the GDP process”Jack – Course Rating 9/10