The latest edition of Pharmacopoeia microbial limit standard

Legal analysis: the microbial limit standard of non-sterile drugs is based on the route of administration, the potential harm to patients' health and the particularity of drugs. Unless otherwise specified, the microbial limit of drugs in the process of production, storage and sale, the inspection of medicinal raw materials, auxiliary materials and traditional Chinese medicine extracts, the formulation of new drug standards, the review of imported drug standards, and the inspection and arbitration of drug quality are all based on this standard.

1. Preparations required to be sterile in the General Principles of Preparations and Varieties of Preparations, preparations marked as sterile and their raw and auxiliary materials shall comply with the provisions of the Sterility Inspection Law.

2 Local administration preparations used for operation, burn or serious trauma shall conform to the provisions of the sterility test method.

3. Microbial limit standards for non-sterile chemical preparations, biological preparations and traditional Chinese medicine preparations that do not contain the raw powder of medicinal materials.

Legal basis: Announcement of the National Health and Wellness Committee of the State Pharmaceutical Products Administration on Printing and Distributing the 2020 Edition (No.78, 2020) According to the provisions of the Drug Administration Law of People's Republic of China (PRC), the 2020 Edition of People's Republic of China (PRC) Pharmacopoeia (hereinafter referred to as China Pharmacopoeia) has been reviewed and approved by the 11th Pharmacopoeia Committee, and is hereby promulgated. Since June 2020, the 2020 Edition of China Pharmacopoeia has been published.