As a pharmaceutical drug substance producer for over 40 years, Grace Fine Chemical Manufacturing Services (FCMS) is extremely well versed with cGMP quality expectations and has demonstrated a strong record of compliance over a long period as a CDMO. Safe performance, protection of our employees and customers, and high-quality service are of paramount importance.
Our quality systems are robust and among the leaders in the CDMO pharma industry. Grace FCMS has experienced quality assurance and quality control groups at both of our sites that operate independently from plant operations to ensure our customers’ needs and expectations are satisfied.
Comprehensive testing and scrutiny
Grace FCMS’s South Haven site has a quality control group that functions 24 hours a day, 365 days a year. It is responsible for testing and verifying that incoming raw materials are within purchasing specifications, that all in-process testing is done in accordance with the specified product, and that the final product conforms with the agreed customer specifications.
Grace FCMS facilities are equipped with sufficient analytical equipment to perform the required testing.
Other equipment can be used or outsourced to audited and monitored third parties. Our analytical equipment is calibrated at set frequencies to ensure that our analyses are complete and accurate.
Typical analytical equipment includes:
- HPLC autotitrators
- Mass Spectometry
- Particle size testing and polarimeters for chiral testing
Manufacturing to cGMP
Grace FCMS’s South Haven site operates under cGMP, bringing in the most stringent quality requirements relating to process and equipment validations, stability testing and documentation control.
Grace FCMS’s quality assurance group is the guardian of the cGMP efforts and conducts activities such as batch record review and final product testing, coordination of annual product reviews, and conducting audits of raw material vendors and outside contractors, as well as coordinating customer audits.
Grace FCMS South Haven provides support for quality assurance across both sites, and the quality management system at Grace FCMS Tyrone is aligned to meet FDA and ICH requirements for RSMs and Intermediates.
Other quality/environmental management systems
- ISO 9000 registered (quality system)
- ISO 14001 (environmental management system)
- OSHA VPP safety systems