A common situation
Based on our experience, if a regulatory agency wishes to join PIC/S, it’s essential that the inspectorate and industry embark on a “joint journey” for the national good.
To gain PIC/S membership, GMP regulatory auditors / inspectors often need to enhance their GMP inspection skills and industry need to enhance their Pharmaceutical Quality Systems. The common goal is to make safe and effective medicines for the general population. A secondary objective many government officials often point out, is that they need to support their country’s rapidly growing pharmaceutical and medical device industries and provide a level playing field to compete on the international stage.
By applying for PIC/S membership, and by the inspectorate becoming PIC/S members, manufacturers in the country have faster access to the global markets as they often have an “approved facility”. Currently, January 2016, there are 48 PIC/S members and the manufacturing plants in those countries, are normally recognised by other regulatory PIC/S inspectorates.
PIC/S GMP Training
In this case study we will take two examples:
Case study 1. An agency needed to get their team of over 50 GMP auditors received PIC/S GMP Training focused on auditing to demanding PIC/S GMP requirements, with practical examples.
Case study 2. A second agency embarked on a two year capacity-building program to enhance their inspectors’ skills and allow industry time to upgrade their facilities and skills and embarked on an extensive PIC/S GMP training program.
In both these case studies PharmOut was able to offer a cost-effective alternative to flying trainers from Europe or the US, by providing a wealth of PIC/S accession knowledge in the Asia Pacific region.
In the case study 1, PharmOut trainers flew to the country and trained the 50+ auditors onsite for 2 days. The training included the practical aspects of conducting GMP inspections and complying with the PIC/S inspection and reporting processes. Detailed technical information about water systems, HVAC systems and other technical aspects that the auditors would typically find at a manufacturing site was also covered.
In the second case study, by coordinating with both the agency and manufacturers in the country, PharmOut was able to provide a cost effective PIC/S GMP training solution by sharing travel costs between them. This permitted cost effective knowledge transfer of PIC/S requirements to both the agency and the local pharma industry, so that both were working together.
In case study 1 the feedback from the regulatory agency was that the trainees were delighted with the training and that it took them significantly closer to achieving PIC/S membership.
In case study 2 the agency achieved PIC/S membership in record time, as industry and the agency were well prepared for compliance to the demanding PIC/S standards.