
PTSM: Pharmaceutical Technology Sourcing and Management
- PTSM: Pharmaceutical Technology Sourcing and Management-11-04-2015
- Volume 11
- Issue 11
Croda's French Facility Receives EXCiPACT Certification
Croda Chocques SAS' excipient facility in France has received EXCiPACT certification from SGS ICS, making it the 24th manufacturing site to be certified to the scheme, which verifies that manufacturing of pharmaceutical-grade excipients meets current good manufacturing practices (cGMPs). It is the third Croda site in Europe to receive this certification in the past year. Certification reflects a rigorous assessment program, both for the auditor and the audited, and the auditor's report had to be verified by an independent certification board.
Croda Chocques SAS' excipient facility in France has received EXCiPACT certification from SGS ICS, making it the 24th manufacturing site to be certified to the scheme, which verifies that manufacturing of pharmaceutical-grade excipients meets current good manufacturing practices (cGMPs). It is the third Croda site in Europe to receive this certification in the past year.
Certification reflects a rigorous assessment program, both for the auditor and the audited, and the auditor's report had to be verified by an independent certification board.
US and European regulators currently require that drug manufacturers provide assessments of their excipient suppliers' conformance to cGMPs, either by conducting their own audits or by using recognized third-party certification programs. Third-party programs such as EXCiPACT's have been designed to reduce the audit burden for drug manufacturers, saving costs and ensuring quality.
Articles in this issue
almost 11 years ago
New Reagents and Reactions Advance Fluorination Chemistryalmost 11 years ago
CMOs Ride Continuing Strength of Small-Molecule Drug Sectoralmost 11 years ago
Lubrizol Introduces Topical Filmalmost 11 years ago
FDA Extends Compliance Dates for Drug Dispensersalmost 11 years ago
Ashland Presents Scientific Studies for Drug Formulationalmost 11 years ago
Xcelience Opens New Headquartersalmost 11 years ago
IPEC-America Suggests Improvements to FDA’s Inactive Ingredients Databasealmost 11 years ago
Catalent Expands Cold-Chain Capacity at Shanghai Facilityalmost 11 years ago
Capsugel Launches enTRinsic Drug Delivery Technology Platformalmost 11 years ago
Rx-360 Names Mark Paxton as New CEO



