Development and control of manufacturing process of chemical raw materials in "Pharmaceutical Research Series"

The control strategy should ensure that the key quality attributes of each API are within the appropriate range, limit, or distribution area to ensure the quality of the API. The quality standard for an API is part of the overall control strategy and not all key quality attributes need to be included in the quality standard for an API. The key quality attributes can be: 1) included in the quality standard and determined by testing of the final API; Or 2) included in quality standards and identified by upstream controls (e.g., through real-time release testing); Or 3) not included in the quality standard, but provided by upstream control. In some cases, process analysis technology (PAT) can be used to enhance process control and ensure product quality.

The information provided on the control strategy should include a detailed description of the individual elements of the control strategy and, where appropriate, an overall summary of the control strategy for the drug substance. It can be in table form or legend form, which is more intuitive and easy to understand. An ideal summary should explain how the various elements of the control strategy work together to ensure the quality of the drug substance.

3. Production process development - life cycle management

The development and improvement of manufacturing processes for apis usually continues throughout their life cycle. The performance of the production process, including the effectiveness of the control strategy, should be evaluated periodically. The knowledge gained from commercial production can be used to further deepen the understanding of the process and its properties, and to adjust the control strategy to ensure the quality of the API. Knowledge gained from other products or innovative technologies also contributes to these goals. Continuous improvement and successful process validation, or continuous process validation, require appropriate and effective control strategies.

Knowledge management should include, but not be limited to, process development activities, technology transfer activities to internal sites and contract manufacturers, process validation studies for the API life cycle, and change management activities. Knowledge and process understanding should be shared as needed to implement manufacturing processes and develop control strategies in the different locations involved in API production. For example, in the initial submission, the applicant may submit a plan for how specific future changes will be managed during the product's life cycle.