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. I recommend that a supplier quality contract be put in place at the beginning of the development process. Maintaining quality in your supply chain at the beginning of the game certainly can`t hurt. If you start educating your suppliers and working productively with them at this point, avoid surprises later in the development cycle – if it may be too late to change a key component or supplier.
A standard operating procedure should be put in place to indicate the types of creditors and services for which a quality agreement is required. At a minimum, an agreement must be reached at any time when an OCM is used, as well as with all suppliers of critical materials. They are recommended for suppliers of large quantities of raw materials or components. The agreement must indicate which controlled and documented changes can be made by the contractor only with notification to the owner and those that must be discussed, verified and approved by the owner before they can be implemented. The agreement should not include such elements as terms and conditions, pricing and stair terms, forecasts, delivery conditions, confidentiality obligations and liability limitations. These items are included in the delivery agreement, which is a separate document. The quality agreement can be included in the reference supply agreement. If both documents are drawn up in one document, the authorization list may contain individuals who have no reason or time to check for problems that have nothing to do with their area of expertise.