Drug makers should consider using a key tool in revised guidance on the manufacture of sterile medicinal products in EU nations and most other countries to engage regulatory authorities on risk-based approaches to the nature and timing of implementation, say two industry experts who have closely followed the guideline’s development.
The new tool, called a contamination control strategy, or CCS, provides for a holistic accounting of risk controls that can...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?