Batch Record Reviews

Pharmaceutical batch records are essential to ensure that regulatory and product quality attributes are achieved. This course describes how to properly perform a batch record review. Topics in this course include: Regulations, Manufacturing Records, Packaging Records, Laboratory Records, and Issues and Deviations. After completing this course, learners will be able to identify the GMP and cGMP requirements for batch records and recognize how to maintain GMP and cGMP compliance throughout the review process. The regulatory requirements of FDA are addressed with reference also made to the requirements of the EU.

After this course learners will be able to recognize the definition of batch records and the purpose of reviews. recognize the key elements and reasons for organized batch records. identify the key components of batch records and the elements of compliance and completeness for batch records.