There are regulatory requirements for quality agreements. Although U.S. GMOs are not currently needed for drugs, it is very likely that they will soon. In 2016, the FDA released the policy paper « Contract Manufacturing Arrangements for Drugs: Quality Agreements. » The addition of a quality agreement requirement to 21 CFR 211 would make GPS in the United States compatible with European Union (EU) GSPs and FDA-accepted ich guidelines (see below). PTE: What mistakes do companies make in establishing quality agreements? Quality agreements are required according to medical device regulations, 21 CFR 820.50 purchasing controls as well as various quality standards such as ISO. It is important to consider these and other recommendations in the current guidelines when developing and implementing agreements with contracting agencies. The scope of the quality agreement should include several compliance activities, such as qualification, calibration and maintenance of analytical tools and manufacturing equipment; Validation of computer systems, analysis methods and manufacturing processes; The specifications used to pass or fail to pass analytical tests Processing, storing and preparing; Receiving, analyzing and communicating samples Collecting and managing laboratory records Gap management and change control. 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.