Ema Quality Agreement Guidance
PTE: What mistakes do companies make when designing quality agreements? Iser: The best way for pharmaceutical companies and subcontractors to create quality agreements that clearly outline each company`s responsibilities is to follow the recommendations regarding roles and responsibilities found in the current guides. The Agency`s current documents clearly set out expectations for the documentation of roles and responsibilities directly related to the responsibilities of the Quality Unit contained in the CMP. and aspects of the pharmaceutical quality system contained in health authority guidelines and ICH guidelines. Manufacturing quality agreements are comprehensive written agreements between the parties involved in the contracted manufacture of medicines that define and determine each party`s manufacturing activities with respect to compliance with mbGP. Robert Iser of PAREXEL Consulting answers questions about the regulatory expectations of quality agreements and how companies can guarantee the quality and safety of their products. The quality contract must be drafted and mutually accepted by the CMO and the customer before the acceptance of the supply contract in order to ensure the identification of all items that will be invoiced and any functional limitations. It should also be noted that the ICH [International Council for Harmonization] Q7 (3) contains useful information on quality agreements with API production sites, supplemented by the FDA`s guidelines on quality agreements. Companies developing combination products should review the expectations set out in the guidelines on current good manufacturing practice requirements for combination products with regard to contractual facilities and quality agreements (4). In early 2013, Chapter 7 of the EU GMP was revised and renamed « Outsourced Activities » to better align with ICH`s Q10 Pharmaceutical Quality System. The principle of Chapter 7 states: « Any activity covered by the GMP Guidelines that is outsourced must be adequately defined, agreed upon and controlled in order to avoid misunderstandings that could lead to a product or operation of unsatisfactory quality.
There must be a written contract between the customer and the order acceptor in which the obligations of each party are clearly defined. The contracting entity`s quality management system shall clearly indicate how the qualified person certifying each batch of the product with a view to its release shall exercise full responsibility. »; A quality agreement should contain at least the following sections: Quality assurance should prepare the agreement with the participation of manufacturing and laboratory personnel from both parties. The quality assurance functions of both parties should review and approve the quality agreement. Nothing should be taken for granted. Each party must review the quality agreement to ensure that its requirements are taken into account. As stated in the FDA`s current Guidelines on Quality Agreements (1), « if all parties clearly understand their GMP-related roles and manufacturing obligations, owners who use contract facilities, contractual facilities that provide services to owners, and ultimately patients who take the drugs manufactured under these agreements can benefit in several ways. each party involved in the manufacture of a medicinal product is responsible for GMP compliance for its manufacturing activities. This shows how important it is to conclude a strong quality agreement and to clearly define the roles and responsibilities of the company and the contractual institution. And in ICH Q10, 2.7, « Does the pharmaceutical quality system, including the management tasks described in this section, extend to the monitoring and review of outsourced activities? The quality responsibilities of the procuring entity and the contractor should be defined in a written agreement. It is important to consider these aspects, as well as other recommendations contained in the current guidelines, when developing and implementing agreements with contracting bodies. A quality agreement is a comprehensive document that describes both the specific quality parameters of a project and the party responsible for executing those parameters. The level of detail of a quality agreement varies depending on the stage of development of the project. #Quality agreements can save a lot of time and money for a #lifescience company by avoiding misunderstandings, but only if the agreements are timely and thorough and have input from all stakeholders, says @MCMasterControl bit.ly/2DwrlEC To avoid misunderstandings, a glossary that defines keywords, acronyms and abbreviations is essential. It is important for everyone to know what is meant by each term used in the quality agreement.
This is especially true for contracts with non-U.S. citizens. Parts, as terminology can vary greatly. Be sure to define all referenced documents. A quality agreement clarifies exactly what is expected of both parties and who will be responsible for virtually every aspect of the project. It also identifies specific aspects of project costs and can thus save time and money. Arvilla Trag, RAC, a consultant at BioProcess Technology Consultants, has 27 years of experience in the development of new drugs. As President and Senior Advisor of Midwest Consulting Services (MCS) from 1997 to 2016, she prepared dozens of INDs and several sections of Modules 3 and 2.3 for OCAs.
In addition to detailed bid preparation, Trag has conducted more than 250 CGMP compliance audits of contract manufacturers and testing laboratories, conducted due diligence audits for mergers and acquisitions, created several quality manuals, and conducted a quality systems gap analysis. She has extensive experience in product types and has participated in more than two dozen product development programs, including monoclonal antibodies, vaccines, small molecules and combination products. Prior to founding MCS, Trag worked as Director of Regulatory Affairs at Biopure from 1994 to 1997, where she prepared the NADA CMC section for hemoglobin-based oxygen-carrying oxyglobin. Prior to joining Biopure, Trag was Responsible for Regulatory Affairs and Quality Assurance at Virogenetics, a vaccine research and development center, where she was responsible for drafting all submissions to the U.S. FDA CBER and CVM and USDA APHIS, SOP maintenance and archives, and collaboration with local regulators. Prior to her work in virogenetics, she spent six years as a laboratory technician in the Department of Neurotoxicology at NYSDOH with mammalian tissue cultures, primary tissue cultures, and IEF and 2D SDS PAGE gels. Trag graduated magna laude from the College of St. Rose in Albany, New York, with bachelor`s degrees in biology and chemistry and certified regulatory affairs (RAC) since 1994. Those who need to know the content of the quality agreement in order to do their job should be involved in reviewing the agreement, including business development, project managers, and law (to ensure compliance with the supply agreement). A standard operating procedure should be in place to indicate which types of suppliers and services require a quality agreement. At the very least, an agreement must be reached every time a CMO 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 ICH Guidelines for the Industry Pharmaceutical Quality System Q10 recommend that, as part of a pharmaceutical grade system, the owner is ultimately responsible for ensuring that « processes are in place to ensure the control of outsourced activities and the quality of materials purchased. » He points out that these processes should include quality risk management and should include critical activities, such as: FDA guidelines (as part of case studies): « No matter who tests the products, the owners` quality units are ultimately responsible for ensuring that the products are manufactured in accordance with GMP.