Individuals who need to know the content of the quality agreement to do their job should be included in the review of the agreement, including business development, project managers and legal projects (to ensure compliance with the delivery agreement). Quality agreements are expressly requested by the EU and the FDA; If you are doing business in another region, it is a good idea to implement a quality agreement, even if it is not a regulatory requirement. Pharmaceutical companies must consider certain considerations when selecting a GMP service provider for validation, qualification and calibration. Companies are generally motivated by high quality standards and the need for partners to meet the requirements of their demanding requirements. Therefore, the ideal outsourcing partner for validation, qualification and calibration services should be: Arvilla Trag, RAC, consultant at BioProcess Technology Consultants, has 27 years of experience in the development of new drugs. As President and Policy Advisor of Midwest Consulting Services (MCS) from 1997 to 2016, she prepared dozens of INDs and several modules 3 and 2.3 for BLAs. In addition to the detailed preparation of the bid, Trag conducted more than 250 CGMP compliance audits conducted by contract manufacturers and testing laboratories, conducted due diligence audits for AMs, established several quality manuals, and conducted deficiency analyses in quality systems. She has a wide range of product type experiments and participates in more than two dozen programs to develop different types of products, including monoclonal antibodies, vaccines, small molecules and combination products. Prior to the creation of MCS, Trag worked from 1994 to 1997 as Head of Regulatory Affairs at Biopure, where she prepared the NADA CMC section for the oxygen carrier based on oxyglobin hemoglobin. Prior to joining Biopure, Trag was responsible for regulatory and quality assurance at Virogenetics, a vaccine research and development organization where she was responsible for drafting all submissions to fda CBER and CVM, as well as TO USDA APHIS, maintaining SOPs and archives, and connecting with local regulators. Prior to virogenetics, she worked for six years as a laboratory technician at the NYSDOH Department of Neurotoxicology and worked on mammalian tissue culture, primary tissue culture and IEF and SDS-PAGE 2D gels. Tragee magna cum laude at the College of St.
Rose in Albany, New York, with bachelor`s degrees in Biology and Chemistry and Regulatory Affairs Certified (RAC) since 1994. “A quality agreement is a comprehensive written agreement between the parties involved in the manufacture of medicines, which defines each party`s manufacturing activities with respect to how each party respects the CGMP. In general, the quality agreement should clearly indicate which party, owner or contracting body, or both, carries out certain CGMP activities. (U.S.)