CPOB Guidelines

This standard replaces the CPOB standard as regulated in Food and Drug Supervisory Agency Regulation Number 34 of 2018 concerning Guidelines for Good Manufacturing Practices for Medicinal Products, which refers to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S GMP Guide) doc . PE 009-16 of 2022, WHO Technical Report Series (TRS) 981 of 2013
(Annex 2), WHO TRS 986 of 2014 (Annex 5), WHO TRS 992 of 2015 (Annex 3 and Annex 5), WHO TRS 996 (Annex 5) of 2016, WHO TRS 999 of 2016 (Annex 2), and WHO TRS 1025 of 2020 (Annex 2).

CPOB aims to ensure that medicines are made consistently, meet the specified requirements and are in accordance with their intended use. CPOB covers all aspects of production and quality control.