Pharmaceutical Inspection Co-operation Scheme: An Overview.

Abstract

To address the challenges posed by the globalization of regulatory agencies, it is essential to harmonize regulatory requirements, assess Good Manufacturing Practice (GMP) compliance, license production facilities, manage product recalls, and improve information exchange. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) provides a robust framework for tackling these global issues. Through the PIC/S GMP Forum, PIC/S facilitates informal interactions among non-member authorities, professionals, and various organizations with the Committee, fostering networking and collaboration. Furthermore, PIC/S has developed a comprehensive guide on GMP requirements for inspectorates and organizations, ensuring consistent standards across borders. The scheme collaborates with other organizations to enhance and complement collective efforts. With 56 countries involved in PIC/S, whether as members or through the Accession and Pre-Accession Process, the exchange of inspection reports among authorities verifies compliance with PIC/S standards, leading to fewer and more targeted inspections and reducing redundancy. This study's purpose is to establish uniform GMP standards by providing extensive training for inspectors and promoting collaboration and networking among regional and international bodies, regulatory authorities, and other relevant organizations. This approach seeks to build trust in inspections, optimize resource use, and foster a more efficient regulatory environment. Through these efforts, PIC/S continues to play a pivotal role in advancing global pharmaceutical regulatory practices.