This course is an adaptation of our standard 1-day GMP course, designed specifically for laboratory staff who have unique, additional requirements laid out in GMP both in the European and USA regulations and guidance documents.
The pharmaceutical quality control laboratory serves one of the most important functions in the manufacturing environment. Many of the GMP regulations and guidances apply to control laboratories but in particular Chapter 6 (QC and Good Control Laboratory Practice) of the EU Guide to GMP. The course also covers the role of documentation, pharmacopoeias, laboratory reference standards, calibration, calculations and results.
The final session of the course brings all this together by a session on preparing for regulatory inspection.
This course is suitable for all laboratory staff working in an environment covered by the requirements of GMP and GCLP (Good Control Laboratory Practice).
By the end of the course you will:
- Have knowledge of the expectations of the regulators in operating control laboratories
- Understand the unique role of testing laboratories in the pharmaceutical environment
- Be able to prepare for regulatory or customer audits
- Good Manufacturing Practice
- Exercise: Sampling
- GMP, QC & GCLP
- Sampling and Testing
- Documentation - What are the GMP Requirements?
- Documentation Situations
- Calculations, Results and OOS
- Control of Standards and Reagents
- Equipment Qualification & Calibration
- Test Method Validation
- Stability Testing
- Preparing for Regulatory Inspection