The document confirms that the delegation of tasks or activities in complex supply chains is possible and sometimes even necessary. However, it states that each delegation must be made in writing, as stated in Chapter 7 of the GMP Guidelines, according to which “any outsourced activity must be adequately defined, agreed upon and controlled in order to avoid misunderstandings that could lead to a product or operation of unsatisfactory quality”. This requirement will likely require many MAHs to review their departmental documentation to ensure that delegated tasks are adequately documented. There is no requirement beyond “written”, but it would be desirable to have such obligations in a written agreement, especially given the extensive responsibilities of the admissions committee, which remain intact at the time of transfer. There are four types of quality agreements: manufacturing, supplier, supplier and service quality agreements, each tailored to the relevant aspects of each type of relationship. “A quality agreement is a comprehensive written agreement between the parties involved in the contract manufacturing of medicines that defines and specifies the manufacturing activities of each party with regard to compliance with the CGMP. In general, the quality agreement should clearly state which party – the owner or the contracting entity, or both – carries out certain CGMP activities. (U.S. Food and Drug Administration [FDA] Guidance “Contract Manufacturing Arrangements for Drugs: Quality Agreements,” 2016.) 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 main conclusions regarding the quality and manufacturing data are listed below: the quality agreement must be drafted and mutually accepted by the CMO and the customer before accepting the supply contract in order to ensure the identification of all items that will be invoiced and any functional limitations.
PTE: Do regulators want to see copies of quality agreements when conducting inspections? 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. »; 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). To obtain marketing authorization for breakthrough therapies, sponsors face the challenge of obtaining clinical, non-clinical, and manufacturing information that meets regulatory approval standards in compressed schedules. The FDA/EMA recognizes this and hosted a workshop on the FDA`s Breakthrough Therapy Designation (BTD) and Priority Medicines (PRIME) programs on the EMA`s Breakthrough Therapy Designation (BTD) programs on November 26, 2018. The objective of the workshop was to facilitate discussion with industry stakeholders on the challenges related to quality, manufacturing and data requirements at the beginning of development, as well as possible scientific and regulatory approaches to address them.
A quality agreement should include at least the following sections: quality agreements are explicitly required by the EU and the FDA; If you`re operating in another region, it`s a good idea to implement a quality agreement, even if it`s not a regulatory requirement. Quality agreements are not only good business practices, there are also regulatory requirements for them. ICH Industry Guide Q7 Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients recommends that owners evaluate contract facilities to ensure contractors` sites are GMP compliant for specific operations. Written agreements should also set out subcontracting considerations. They should describe how changes to processes, equipment, methodologies and specifications are managed, and allow the owner to verify compliance with the PMCCs of their contractor`s facilities. 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. Iser: There are common mistakes that happen when companies design quality agreements. First, the roles and responsibilities of the pharmaceutical company and the contract manufacturer are not always clear, especially when it comes to defining and agreeing on the responsibilities of the quality unit. Second, some agreements are interpreted in a way that deviates from the expectations of the CGMP (e.B. interprets a contract manufacturer that he does not have to carry out an investigation into a result produced by him outside the specifications, since the pharmaceutical company is responsible for the release of commercial batches), which can lead to observations during an inspection. Thirdly, a mechanism for regular evaluation and, where appropriate, revision of the agreement is not always included in the agreements. Finally, some quality agreements contain contractual or commercial commercial aspects and should focus only on quality management aspects as defined in applicable regulations such as the US Code of Federal Regulations (CFR) 211(5) or guidance documents such as ICH Q7 (3) or Q10 (6). For more useful information on how to avoid these mistakes, check out the FDA`s latest industry guidance (1). A concrete example of compliance [FDA] 483 related to quality agreements is a contractual testing facility cited for not following a quality agreement on the destruction of the remaining samples with the contractor`s approval. This is related to the importance of establishing clearly defined roles, meeting roles under an agreement, and ensuring that they meet GMP expectations. .