QA&QC
QA:Quality Assurance
QA Operations have been in place for several years to insure that products at our company are prepared responsibly and in accordance with ISO 9001 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.
QC:Quality Control
Analytical support for lab and production ranges from the release of raw materials to in-process control. This includes the development of chromatographic methods as well as structural determination of impurities and by-products for release testing. Validation of analytical methods, and the preparation and characterization of reference standards are also available for more advanced projects. Major analytical equipment pls see Analytical Facilities
Activities and Responsibilities:Development and approval of specifications;
- Development and approval of specifications;
- Sampling, analytical check and release of raw materials, intermediates and cleaning samples;
- Sampling, analytical check and approval of APIs and finished products;
- Release of APIs and final products;
- Qualification and maintenance of equipment;
- Method transfer and validation;
- Approval of documents: e.g. analytical procedures, SOPs;
- Stability tests;
- Stress test.