Effective Batch Record Review

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A Batch record review is a complicated and often lengthy process. However, a strong review system is essential so all critical processing parameters are properly documented. Learn the fundamentals of batch record reviewing and its necessary elements, in this manual

Regulatory agencies often require firms to have written procedures to document production and process controls. These written procedures are known as batch records, and they in turn require a batch record review process, to demonstrate compliance. Reviewing batch records can be tough work, especially if you do not know what to do at each step. In this manul, our expert researcher will walk you through the subject of batch record reviews, providing crucial information and equipping you with tools which will help you perform your duties better.

You will learn the regulatory requirements for batch record review, and what to look for during a batch record review – good documentation practices, compliance to critical quality attributes and critical processing parameters, etc. You will also learn about a training plan which batch record reviewers must undergo, before they are considered qualified for the job.

How to establish a strong working relationship between production and quality reviewers, how to ensure that production and quality reviewers coincide with their reviews, and more.

  • Learn the fundamentals of batch record review in a pharmaceutical environment
  • Learn the regulatory requirements for batch records and for reviewing them
  • Learn what to look for while reviewing batch records
  • Learn the essential skills and responsibilities of an effective reviewer
  • Gain useful tools for reviewing batch records
  • Learn how to ensure that Production and Quality reviewers coincide with their reviews
  • Learn what steps to take when a batch does not meet specifications
  • Learn about training required to become a qualified batch reviewer

Intended audience

Quality Assurance and Batch Record Reviewers, Production Personnel, Production Managers, Compliance Auditors, Manufacturing Management & Scientist, Other professionals who review batch records

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