As a pharmaceutical drug substance producer for over 40 years, Albemarle Fine Chemistry Services 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. We have 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.
Our 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.
The 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.
South Haven operates under cGMP, bringing in the most stringent quality requirements relating to process and equipment validations, stability testing and documentation control.
Our 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 ouside contractors, as well as coordinating customer audits.
South Haven provides support for quality assurance across both sites, and the quality management system at Tyrone is aligned to meet FDA and ICH requirements for RSMs and Intermediates.