And in JE Q10, 2.7, “The pharmaceutical quality system, including the management responsibilities described in this section, covers monitoring and verification of outsourced activities… Responsibilities for the quality of the donor`s and contractor`s activities should be defined in a written agreement. It is wrong to believe that quality agreements are only necessary for the use of CMOs operating in a different regulatory environment. This is not the case – any outsourcing contract should have a related quality agreement, including agreements between different departments of the same company, regardless of the physical location of one of the parties involved. Another example: if the quality agreement is “Batch Record Review, five days” requires clarification. Is it a MBR or an RPO? Is it five working days or five calendar days? These are details that can make a big difference. Quality agreements are required according to medical device regulations, 21 CFR 820.50 purchasing controls as well as various quality standards such as ISO. In early 2013, Chapter 7 of the EU GIP was redesigned and renamed “Outsourced Activities” to bring it more in line with the ICH Q10 drug quality system. The principle of Chapter 7 is: “Any activity that falls under the GMP guide and is outsourced should be defined, agreed and controlled accordingly in order to avoid any misunderstanding that could lead to an unsatisfactory quality product or operation. There must be a written contract between the contract giver and the processor that clearly defines each party`s obligations. The contract supplier`s quality management system must clearly state how the qualified person who certifies each batch of products for release exercises full responsibility. One of the most overlooked sections of the FDA guide is the definition section. It is essential that everyone knows what is meant by any term used in the quality agreement; especially for contracts with non-U.S.
companies, the terminology can be very different. Insert abbreviations and acronyms and set documents – one person`s data sheet is another person`s data sheet. Define “outsourcing” and if and when it is acceptable. On the other hand, quality agreements do not include terms and conditions, confidentiality obligations, prices and costs, delivery conditions, limitations or damages of liability or forecasts.5 Arvilla Trag, RAC, consultant at Bio TechnologyProcess 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.