Good Manufacturing Practice (GMP) for medicinal products relies on documentation. Good Documentation Practice (GDocP) is that part of GMP that applies to the creation, maintenance, use, and retention of documents to provide assurance of the quality of products.
A company’s Corrective and Preventive Action (CAPA ) system establishes how personnel should deal with manufacturing problems that have occurred or that may occur if not prevented. This module explains the principles of corrective and preventive action and describes typical CAPA procedure. It goes on to introduce root cause analysis and outline the role of progress tracking, escalating, and trending of CAPA procedures.
This module will introduce you to monoclonal antibodies, explaining how they work, how they are made, and the many uses to which they are put.
Operations in the dispensary and on processing lines are at the heart of medicinal product manufacturing. This module describes how to carry out such operations in compliance with the requirements of Good Manufacturing Practice.
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