ICH Q13 guidelines on continuous manufacturing in pharmaceuticals in China have been incorporated into a draft for comment released by the Center for Drug Evaluation (CDE) entitled: Guidelines for Continuous Manufacturing of Chemical Pharmaceutical Oral Solid Dosages (Draft for Comment)”.
The CDE is seeking industry stakeholder comments before October 10, 2022.
- The draft guidelines are applicable to the continuous manufacturing (CM) of oral solid dosage (OSD) chemical drugs and the continuous manufacturing system described therein refers to a system composed of two or more solid unit operations directly connected.
- The aims of the draft guidelines are to encourage innovation and modernization in the pharmaceutical industry, guide the research and development of enterprises and of course assist the implementation of the ICH Q13 guidelines in China.
- CM is one of the important advanced development directions of intelligent manufacturing in the pharmaceutical industry in the new era. Continuous manufacturing in pharmaceuticals can theoretically be applied to both raw materials/raw liquids and formulations. CM in pharmaceuticals is still in its infancy compared with CM which has been successfully applied for many years in the automotive, food, consumer goods, and petrochemical industries.
- In the pharmaceutical industry, traditional batch manufacturing technology is still the mainstream mode of production. However, with the release of the draft “Q13: Guidelines for Continuous Manufacturing of Drugs and APIs” by the ICH in July 2021, the development of continuous drug manufacturing supervision has entered a new era. The ICH has been soliciting comments from various regulatory member institutions including the CDE and in response, it issued a notice seeking comments on ICH Q13 on October 18, 2021.
- On the premise of remaining consistent with the basic principles and concepts of ICH Q13, whilst taking into account the current situation of China’s pharmaceutical industry, the CDE has issued more detailed guidelines for the implementation of continuous manufacturing of OSD chemical drugs. This draft guideline clarifies the basic ideas and regulatory considerations for continuous manufacturing including batch definition, control strategy formulation, process validation and stability studies, and batch changes of OSD chemical drugs.
How to submit comments
Comments from the industry can be submitted using the feedback form to the following email addresses: huych@cde.org.cn and fengx@cde.org.cn
Further information
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