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Sterile Drug GMPs: CCS Tool Could Help Bridge Compliance Gaps As Annex 1 Revisions Take Effect

 
• By Bowman Cox

Experts who led PDA’s interactions with EU, PIC/S and WHO authorities on first-ever comprehensive revision of sterile drug product manufacturing guidance recently shared insights on implementation priorities with the Pink Sheet.

Closing the gap
a new strategy for closing compliance gaps • Source: Shutterstock

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...

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