Reviewing Drug Product Batch Records

Mark Powell

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Batch record review is an important step in the release of a medicinal product. This webinar sets out the regulatory requirements for batch records and sets out a systematic approach for review. Trending of batch data is also discussed. 

Why Should You Attend:

Batch record review is a GMP requirement. Furthermore, the 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 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.

Areas Covered in the Webinar:

  • Regulatory requirements for batch review (EU and US)
  • Important areas to check in batch records
  • Common errors
  • Examples of deficiencies leading to regulatory enforcement action
  • Overview of the draft ICH Q12 guidance
  • ICH Q12 and Quality by Design
  • Benefits of continuous improvement
  • Approaches to data trending

Frequently Asked Questions:

  1. A batch record should be checked before it is issued to production. Can this check be done by production or must it be done by quality?
  2. Does batch record generation software have to be Part 11 compliant? Can Microsoft products be used to generate these batch records? Do batch record generation programs have to be validated?
  3. Is it expected to have a complete graph or printout of the whole process batch attached to the batch record for a critical or significant step?
  4. Any tips for organizing MBR for readability by the operator?

Who Will Benefit:

  • Production staff
  • Production management
  • Quality assurance professionals
  • Qualified persons (EU)
  • Regulatory affairs professionals

Free Materials:

  • Links to free web-based resources
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Mark Powell, Director, Mark Powell Scientific Limited

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

Get in touch

(315) 632-0735,
(315) 750-4379