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Management Procedure of Annual Product Quality Review

Quality specifications, quality of excipients and packaging materials, deviation survey and treatment program, critical control point and product analysis, on-going stability test and adverse trend etc。 are included in the content of quality reviews。

The most important is to study the quality specifications, process parameters and trend analysis.

The quality management dept. evaluate the review results and then propose the Corrective Action and Preventive Action (CAPA) or the suggestions and reasons for re-evaluation or re-qualification.

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