The 2025 Edition of Chinese Pharmacopoeia Introduces ICH Concept-Formulating Appropriate Microbiological Standards
Release time:
2024-07-05
The publicity draft issued again by the National Pharmacopoeia Committee introduces ICH risk management concept. The "Publicity Draft of Guidelines for Microbial Limit Examination of Non-sterile Products in Annex 9202" provides practical reference value for enterprises to formulate appropriate microbial limit examination standards for non-sterile products. Dust Amy shares specific contents with you.
The publicity draft issued again by the National Pharmacopoeia Committee introduces ICH risk management concept. The "Publicity Draft of Guidelines for Microbial Limit Examination of Non-sterile Products in Annex 9202" provides practical reference value for enterprises to formulate appropriate microbial limit examination standards for non-sterile products. Dust Amy shares specific contents with you.
（1）Selection of Control Medium-Whether it is in the pharmacopoeia of China, the United States, Europe and Japan, the training performance (applicability) is specifically described. The control medium selected in China is generally developed and distributed by the China Institute for Food and Drug Control. However, it is often found that some varieties of control medium cannot be purchased. Therefore, enterprises need to select the control medium by themselves. If they need to select the control medium by themselves, adequate risk assessment should be carried out to ensure that it meets the requirements of inspection methods and the consistency of inspection results.
（2）Microbial limit criteria for non-sterile pharmaceutical products need to be considered for control of bacteria.-In the microbial limit standard for non-sterile drugs, only the total number of aerobic bacteria, molds and yeasts are required to be checked for pharmaceutical raw materials, auxiliary materials and traditional Chinese medicine extracts. Therefore, when formulating the microbial limit standard, unacceptable microorganisms with potentially harmful pathogenic bacteria should be controlled according to the microbial contamination characteristics, uses, production process and characteristics of corresponding preparations and other factors.
（3）Testing frequency and standard requirements-- The control of the microbial limit of non-sterile chemical raw materials shall be based on risk assessment, and the risk assessment method can refer to the risk assessment and management tools recommend in ICH Q9 Quality Risk Management. Risk assessment shall comprehensively consider the nature of non-sterile chemical raw materials (including starting materials, solvents, reagents, catalysts, etc.), production process, production environment, equipment cleaning status, personnel quality, worst production conditions, historical data and trends. On the basis of the risk assessment, a preliminary determination is made as to whether microorganisms can grow or survive in raw and auxiliary materials, whether the production and treatment steps of raw and auxiliary materials will reduce microorganisms, so as to determine the microbial limit inspection strategy (regular sampling or batch-by-batch inspection or inspection may not be considered) and the corresponding microbial limit standards.
Non-sterile chemical preparations and raw materials microbial limit risk assessment and control strategies are evaluated according to the following decision tree:
L non sterile chemical raw materials microbial limit test decision tree
l Decision tree for microbial limit test of non-sterile chemical preparations
Key words:
Related Blog
Durst DST Regulation Group, noting that on July 1, 2024, the Drug Evaluation Center of the State Drug Administration (hereinafter referred to as CDE) issued a trial notice on the submission of electronic application materials for drug registration by network transmission. Starting from July 1, 2024, the trial work on the network transmission of electronic application materials for drug registration will be started, and applicants can submit electronic application materials for drug registration through network transmission. There is also an attachment: the reservation for network transmission of electronic declaration materials and the description of operation steps, which is convenient to guide everyone to submit electronic declaration materials.
2024-07-05
Recently, after the products of DST DST customers Sichuan well-known pharmaceutical companies passed PAI inspection in November 2023, they were officially approved in December. In June 2024, they officially sent several batches of products to enter the US market. This exciting news came at the time of the third FDA project audit of the client again. The customer is located in Neijiang City, Sichuan Province, an ancient city between Chengdu and Chongqing. The success of Huiyu Pharmaceutical has made this city more attractive to pharmaceutical people! Once again, congratulations to the customer products officially go to sea! The entry of products into the US market shows that DST customers have been strictly implementing quality management according to high standards, continuously optimizing production processes, and producing more high-quality products higher than national standards.
2024-07-05
Recently, after the products of DST DST customers Sichuan well-known pharmaceutical companies passed PAI inspection in November 2023, they were officially approved in December. In June 2024, they officially sent several batches of products to enter the US market. This exciting news came at the time of the third FDA project audit of the client again. The customer is located in Neijiang City, Sichuan Province, an ancient city between Chengdu and Chongqing. The success of Huiyu Pharmaceutical has made this city more attractive to pharmaceutical people! Once again, congratulations to the customer products officially go to sea! The entry of products into the US market shows that DST customers have been strictly implementing quality management according to high standards, continuously optimizing production processes, and producing more high-quality products higher than national standards.
2024-07-05
Argument! Hengrui Warning Letter, Is It FDA's Political Sanction?
Tieguai Liu saw many posts about whether there were political factors in Hengrui's warning letter. Today, Tieguai Liu will discuss this matter with everyone's concerns. First of all, we are very sensitive to see that the "first brother" of China's pharmaceutical industry has received a warning letter from the FDA of the United States. For today's Sino-US environment, we naturally think of the FDA's sanctions against the first brother due to the influence of US politics. It is completely understandable from everyone's interpretation. The following Tieguai Liu will discuss with you from both positive and negative dimensions:
2024-10-25
Durst DST continues to pay attention to the drug regulatory policies of countries around the world to help companies go to sea, and the following is the drug regulatory situation in Southeast Asian countries and regions.
2024-10-25
Contact Information
Durst (Shenzhen) Consulting Service Co., Ltd.
Contact Phone:86-18826007039
E-mail:consulting@delsalt.com
Address: C19, Building 1, Yongheyuan, Zhuangbian Community, xixiang street, Bao 'an District, Shenzhen City, Guangdong Province
Sweep to identify concerns:
Scan attention consultation