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 document states e. g. that a pharmaceutical company should have a system in place […]

Read More »

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 validation plans for facility / equipments / process including cleaning. Approval of protocols […]

Read More »