This Education Course will give a comprehensive overview of the main GMP requirements for quality control laboratories, from a European as well as from the U.S. (FDA) perspective. It is the aim of the course to address the challenges that QC Compliance Managers face today regarding the relevant regulatory requirements and how to successfully implement these requirements in the analytical lab.
Due to changing regulatory requirements pharmaceutical Quality Control Compliance Managers are continuously facing new challenges. There are many regulatory requirements relevant for the pharmaceutical quality control, both in EU and in the US, for instance:
- EU GMP Guide (Part 1 / Part 2 / Annexes)
- 21 CFR Part 210/211 (USA)
- Guidances (EMA and FDA)
- ICH Guidelines
- WHO and PIC/S Recommendations
- Pharmacopoeias (Ph.Eur., USP)
QC Compliance Managers must be familiar with all these GMP-related topics and must be aware of the latest updates and the current interpretation of all these guidance documents.
In addition, analytical QC laboratories are increasingly in the focus of GMP inspections, both in Europe and in the US. For instance after FDA inspections, many laboratory-specific citations can be found in 483s and Warning Letters. And many findings related to the laboratory can also be found after inspections of European GMP supervisory authorities. Key compliance requirements include:
- Change control systems
- Calibration and qualification of analytical instrument
- Reference standards
- GMP compliant documentation
- Validation of analytical methods
- Stability program
- Validation of computerised systems
- Procedures for handling OOS results
All these key compliance issues will be addressed in this course and the main topics also deepened in workshops.
This year’s programme has been further updated to include the current challenges of Laboratory Data Integrity issues in analytical labs about reporting and invalidating laboratory results.
Please note that the emphasis of this course is on small-molecule pharmaceuticals. The course will not focus on biotech products.
This Education Course will be of significant value to
- Laboratory managers,
- Quality control managers,
- Analytical scientists,
- Senior laboratory staff
from quality control units in the pharmaceutical industry who are responsible for GMP Compliance in the analytical laboratory.