cGMP Testing

CA Analytical Testing Services has extensive expertise in performing analytical testing which supports regulatory requirements for drug and device products, packaging, and manufacturing processes in compliance with U.S. FDA Current Good Manufacturing Practices (21 CFR Parts 210 and 211).

Our team has conducted a wide range of studies, including method development and validation, drug and device testing using validated methods or USP/NF and Ph. Eur. compendial methods, dissolution testing, stability studies, and leachables/extractables analysis. We also perform troubleshooting and failure analyses to provide production support for our clients.

CA Analytical Testing Services maintains a fully compliant quality system, enhanced with additional procedures to meet cGMP requirements and ensure data integrity. These include a document management system which maintains and archives all SOPs, structured compliance training with formal records, secure data storage, and backup of all administrative and laboratory data. All instruments are fully qualified before use, calibrated regularly with USP or other certified standards, and re-qualified at defined intervals to maintain performance reliability. An independent Quality Assurance Unit audits every quality system and cGMP study dataset to confirm adherence to regulatory standards.