This guiding principle sets out requirements and gives guiding opinions on the manufacturing process from the aspects of basic concepts, process development, industrial equipment, and quality control around the continuous manufacturing of raw materials and intermediates. It aims at continuous manufacturing with high intrinsic safety level, high degree of automation, and low greenness. Based on the technical characteristics of carbon environmental protection and high production efficiency, based on GMP and the clean production evaluation index system of the chemical API manufacturing industry, a process guide for the development and production of continuous manufacturing technology for APIs and intermediates is established, aiming to provide enterprises with continuous manufacturing for APIs and The synthesis of intermediates serves as a guide.
T/PIAC 00001-2023 history
2023T/PIAC 00001-2023 Guidelines for Continuous Manufacturing of Drug Substances and Intermediates
2022T/PIAC 00001-2022 Requirements for Professional and Technical Competence of Corporate Compliance Officers in the Pharmaceutical Industry
2021T/PIAC 00001-2021 Method for determination of penicillin in antibiotic fermentation residue, raw fertilizer material, crop, and related environments
2021T/PIAC 00001-2020 Pharmaceutical Industry Compliance Management Standards