Training BFDA auditors in the Phillipines

The situation

The Bureau of Food and Drug Administration (BFDA) in the Phillipines is the GMP regulator for the country. To support the country's rapidly growing pharmaceutical and medical device industries, the BFDA decided to apply for PIC/S membership. By becoming PIC/S members, companies manufacturing in the Phillipines would then have better access to the global market.

To support their PIC/S membership application, the BFDA needed to get their team of over 50 GMP auditors trained on auditing to PIC/S requirements. They wanted practical, hands-on training and had a very limited budget to achieve this.

The solution

PharmOut was able to offer a cost-effective alternative to flying in PIC/S trainers from Europe. With several ex-regulator auditors on the PharmOut team, there was a wealth of PIC/S auditing knowledge to draw from.

PharmOut trainers flew to Manila and trained the 50+ auditors in 2 days. The training included the practical aspects of conducting GMP audits and complying with the PIC/S process, as well as detailed technical information about water systems, HVAC systems and other technical aspects that the auditors would typically find at a manufacturing site.

The results

The feedback from the BFDA was that the trainees were delighted with the training and that it took them significantly closer to achieving PIC/S membership.