Reviewing Drug Product Batch Records

Why Should You Attend:

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.

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

Mark Powell
Director, Mark Powell Scientific Limited

Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for method development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programs as well as establishing collaborations with academia and instrument manufacturers. His work resulted in a number of published papers and presentations at international scientific conferences. In 2013, he set up his own company to provide training and consultancy services to pharmaceutical professionals. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programs and conducting data integrity audits. He is in demand as a trainer in topics such as chromatography, spectroscopy, pharmaceutical dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies and sample preparation.

Follow us :