آخر تحديث - 11 أبريل 2021
A quality agreement should include at least the following sections: A quality agreement (also called a technical agreement and, in this context, the conditions are interchangeable) is a written contract that is necessary when a company relocates an activity under the Guidelines on Good Manufacturing Practices (“GMP”). It defines the responsibilities of the various parties with respect to GMP. “The manufacture and analysis of orders must be properly defined, agreed and controlled to avoid misunderstandings that can lead to an unsatisfactory quality product or work. […] The contract must clearly state how the qualified person who releases any batch of product put up for sale assumes full responsibility” (extract from the rules on medicines in the European Union, Volume 4, good manufacturing practices, Chapter 7, manufacturing and order analysis). One of the many important details of quality agreements are time slots. If a CMO wants a five-day processing period to verify a master batch (MBR) record, this may be helpful because no data is to be verified. However, if the CMO wants a five-day rotation to verify a batch production dataset (RPO), this is not reasonable in most cases. There is simply too much data to check to be able to do a thorough job in five days. 7.11 clearly defines and discusses the relationship between the contractor and the contractor, and the second (user) should not at any time outsource to a third party without prior evaluation and approval of the agreements by the donor. This is well taken into account when outsourcing to third world countries, based on a clear understanding of the dynamics of product production activities. Although the word “manufacturing” has been defined in ICH Q7a`s GMP guide to mean “all material input operations, production, packaging, packaging, labelling, rebelling, quality control, release, storage and distribution of APIs and related controls,” the words “and laboratories” were included in the title of this chapter to make it clear that this chapter also applies to any laboratory that could perform an analysis for the manufacturer of API in accordance with a specific request. In almost all cases of outsourcing of BMP`s activities, there will also be a trade agreement covering outsourced activities, such as a “manufacturing and procurement agreement,” for example.B. This trade agreement is generally developed by legal and commercial development staff and does not go into detail to comply with the principles of the GMP.
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.