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This section specifically applies to those products approved after the issuance of this guideline. A considerable portion of the section is taken up by what amounts to a description of lifecycle management and the need for an appropriate quality system. It is perhaps not wholly clear as to why this is included as it is not specific to the control of mutagenic impurities.

What is clear and useful is the statement that any proposed change to the manufacturing process should be evaluated for the impact on the quality of DS and DP. This evaluation should be based on understanding of the manufacturing process and should determine if appropriate testing to analyze the impact of the proposed changes is required.

It also stresses the need throughout the lifecycle of the product to reassess if testing is recommended when intended or unintended changes occur in the process, highlighting the need to consider this in particular where there is no routine monitoring (Option 3 or Option 4).

Mention is also made as to the potential use of statistical process control and trending of process measurements, but in the absence of any clear examples, it is not entirely clear as to how this might be utilized.