Services:
cGMP Manufacturing
cGMP Compliant Manufacturing in a Class 10,000 Clean Room
Chata Biosystems maintains an auditable quality assurance program in accordance with the requirements of cGMP manufacturing. Our products are made to the exact specifications of our clients including traceability for each chemical component and solvent. Batch records are maintained for each lot. They describe in detail each constituent, order of addition, mixing requirements, filtering, pH adjustment, degassing and list the requested quality testing parameters.
Manufacturing is performed in our Class 10,000 clean room using our validated water system that meets USP Purified Water and ASTM-1A specifications.
Product is released to your location with a Certificate of Analysis that presents the results of quality control tests and lists the expiration date for products with supporting stability test data.
Manufacturing is performed in our Class 10,000 clean room using our validated water system that meets USP Purified Water and ASTM-1A specifications.
Product is released to your location with a Certificate of Analysis that presents the results of quality control tests and lists the expiration date for products with supporting stability test data.
