Reviewing Drug Product Batch Records

Batch record review is a GMP requirement. Furthermore, trending of manufacturing data facilitates continuous product improvement, which is the focus of a pending ICH guidance document (ICH Q12). Pharmaceutical manufacturers will be expected to demonstrate that their manufacturing processes continue to produce medicinal products of a consistently high quality.

Batch records can also be used to identify sources of manufacturing variability, enabling improvements to be made to the production method. This webinar details current regulatory expectations and sets out a logical approach for batch record review. Methods for trending batch data will also be discussed. In addition to understanding regulatory expectations, you will learn how to use batch records as tools to facilitate continuous improvement.