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, 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:
- 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?
- 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?
Who Will Benefit:
- Production staff
- Production management
- Quality assurance professionals
- Qualified persons (EU)
- Regulatory affairs professionals
