CAPA (Corrective Action Preventive Action) and failure investigation become more and more important for the pharmaceutical industry. This becomes clear in a series of guidance documents. Above all with the ICH Q10 document, CAPA was introduced as a new quality-assuring tool. This…

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Technology Transfer : Receipt of product design documents from Research Center. Distribution of documents received from Research Center (RC). Checking & approval of documents generated based on RC documents i.e. Batch Manufacturing Record. Scale-up and validation of product Validation : Preparation of…

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