QA insures the products from our company are prepared responsibly and in accordance with ISO 9001 standards.

     Activities and Responsibilities:

    Release of qualification and validation protocols;

    Release of documents: specifications; Master Batch Records, SOPs;

    Batch reviewing and releasing, 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.