QA:Quality Assurance

QA Operations have been in place for several years to insure that products at Capotchem are prepared responsibly and in accordance with ISO 9000 standards.

With QA available in every shift, compliance to the demands of cGMP is now in-use. Our pharmaceutical/biotech customers are welcomed and considered an integral part of our commitment to continuous quality.

Activities and Responsibilities.

•  Release of qualification and validation protocols;

•  Release of documents: e.g. specifications; Master Batch Records, SOPs;

•  Batch review and release, archiving;

•  Release of batch records;

•  Change control, deviation control, investigations;

•  Approval of validation protocols;

•  Training;

•  Internal audits, compliance;

•  Supplier qualification and supplier audits;

•  Claims, recalls, etc.