Pics Gmp Agreement

The European Medicines Agency (EMA) and numerous drug regulatory authorities in the Member States of the European Union (EU) are participating in the Convention on Drug Inspection and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), close international cooperation between pharmaceutical supervisors in the field of good manufacturing practices (GMP). Replaces questions and answers regarding the Code of Good Drug Manufacturing Practices The Agency also supports the assessment of the GMP equivalency of potential participating authorities, inspection activities and the exchange of inspection information. Updated following the adoption of the PIC/S Guide to Good Drug Manufacturing Practices PE009-14 ISPE is currently in discussions with PIC/S on improving the GMP Inspection Reliance Initiative, finding a way to collect metrics and information on cases where double inspections of the same magnitude are carried out, with this information being referred to peak/S for appropriate action. The information requested by the applicant authority could be a GMP certificate and/or a recently published GMP inspection report. Additional information may be requested from the production site (for example. B the company`s CAPAs during the last inspection, the result of inspections carried out by other regulatory authorities, the basic location file, etc.) to carry out the remote inspection (office inspection). The applicant authority informs the production site and, as a general rule, the hosting authority of the results of the remote inspection. Stay up-to-date on the latest published articles, white papers, technical articles, call articles and more by logging in to receive notifications from Pharmaceutical Engineering Magazine. The benefits of this GMP initiative for the reliability of inspections are the reduction of double inspections of an equivalent magnitude for industry and the resulting savings, as well as the use by regulators of inspection resources to draw their attention to high-risk problems at home and abroad. PIC/S, a non-legal cooperation agreement between 52 regulators 5 from around the world, recently adopted a GMP Inspection Reliance Guidance 6 (PIC/S document PI 048-1) that encourages ICP/S member authorities to rely on the results of GMP inspections conducted by other members instead of conducting their own inspections abroad. This manual contains a procedure to confirm GMP compliance through a remote inspection process (office).