An NSF International Company How to cope with an unprecedented level of change?
Wednesday the 5th March 2014
The pharmaceutical industry is facing a blizzard of new legislation and guidance. How can quality professionals and their senior management cope with this? Are senior management even aware of much of this change? Some of the changes (ICH Q10, EU GMP Chapters 1 and 2) make it very clear that ultimately senior management are responsible for the quality system. How many senior managers realise this? Do they still think that quality is solely the responsibility of the QA department?
Just some of the current, far reaching changes that are happening include:
- New measures to increase robustness of supply chains to protect against counterfeit starting materials and products (e.g. US FDASIA, SSCPP and DQSA; EU FMD - excipient GMP, API GDP and supply chains, safety features, etc.)
- New expectations for controlling cross-contamination based on health-based exposure limits
- New expectations for analytical method validation and transfer
- New expectations for process validation
- Serialisation and tracing of packed products across the world
Find out about these profound changes and how to cope on our Pharmaceutical Legislation Update course. For details see: pharmaceutical-legislation-update
