Written Quality Agreements

iv. Manufacturing activities – to document quality units and other activities related to manufacturing processes, and to control changes in manufacturing processes 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. Trage 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. In addition, I have Q7, which is the application of GMP to Pharmaceutical Active Ingredients (API), section 16, entitled “Contract Manufacturing (including Laboratories).” This document was published by the FDA under the title “Guidance for Industry” (6) and is Part 2 of the EU GMP (7). Section 16 states that “there should be a written and approved contract or formal agreement between a company and its contractors specifying the responsibilities of the PMPs, including quality measures, of each party.” As mentioned in the chapter title, the scope covers all contract laboratories, implying that a formal contract or service agreement is required for the API manufacturer or a third-party laboratory that conducts testing on their behalf.