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;

•  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.