Yes, there are regulations and standards for the production and supply of pharmaceutical intermediates from pharmaceutical intermediate suppliers. Here are the relevant regulations and standards in China and some international regions:
- Chinese regulations and standards
- Relevant laws and regulations: The production and supply of pharmaceutical intermediates from pharmaceutical intermediate suppliers in China are mainly regulated by the "Drug Administration Law", "Regulations for the Implementation of the Drug Administration Law", "Drug Registration Management Measures", and "Good Manufacturing Practice for Drugs" (GMP). The "Drug Administration Law" stipulates that pharmaceutical intermediates from pharmaceutical intermediate suppliers belong to drugs and must be produced, operated, and used in accordance with the provisions of the Drug Administration Law. The "Regulations for the Implementation of the Drug Administration Law" requires that pharmaceutical intermediates from pharmaceutical intermediate suppliers must be approved by the National Medical Products Administration before they can be produced and sold.
- Quality management requirements: The "Good Manufacturing Practice for Drugs" requires that the production of pharmaceutical intermediates from pharmaceutical intermediate suppliers must meet the requirements of GMP. Pharmaceutical intermediate production enterprises must establish a quality management system, including standard operating procedures and a comprehensive documentation system, to ensure the quality and safety of products. In addition, the National Medical Products Administration has also issued relevant appendices to further clarify the quality management requirements for pharmaceutical intermediates from pharmaceutical intermediate suppliers, such as the "Appendix for Pharmaceutical Excipients" and the "Appendix for Pharmaceutical Packaging Materials".
- International regulations and standards
- United States Pharmacopeia (USP) and European Pharmacopoeia (EP): USP and EP are important international pharmacopoeias. pharmaceutical intermediates from pharmaceutical intermediate suppliers that meet the standards set by USP and EP can ensure the quality and safety of drugs. These standards cover various aspects of the manufacturing process, including raw material sourcing, production methods, and quality control measures.
- Good Manufacturing Practice (GMP) in the United States and Europe: The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require that pharmaceutical intermediate production must comply with GMP standards. These regulations are designed to ensure the safety, efficacy, and quality of medications. Companies need to maintain detailed records and conduct regular quality control testing to ensure compliance with regulatory requirements.