Is there any clear description of domestic regulation regarding that the scale of process validation should be commercial scale, and it cannot be replaced by pilot scale?

刊登日期:2019-11-22  |  點閱次數 : 1376 次 

Yes. Please refer to PIC/S: Guide to Good Manufacturing Practice for Medicinal Products (Part I Annexes):

  1. 1. "Normally batches manufactured for process validation should be the same size as the intended commercial scale batches and the use of any other batch sizes should be justified or specified in other sections of the GMP guide."
  2. 2. "Significant amendments to the manufacturing process, including any change in equipment or materials, which may affect product quality and/or the reproducibility of the process should be validated."

Since the manufacturing process and quality of drug product are affected by different batch sizes, it is recommended that batch size for process validation should be the commercial scale.



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