Typical GMP Audit Topics and Schedule

PCS has 31 years of experience in auditing pharmaceutical organizations. We assess the Quality Management System (QMS/PQS), the process(es) and the organization as a whole.

The presentation below shows the topics PCS would normally cover on a one-day GMP audit. We have based the audit on a production organization. Process-specific topics have been excluded for the purpose of this presentation e.g. cell banks, autoclaving, etc.