Quality Agreement Qag

Table 2 presents the categories (in alphabetical order, not in order of importance) that should be considered for inclusion in quality agreements in terms of applicability. The categories depend on the type of quality agreement, but are not definitively limited to those presented. Although the agreement is usually the responsibility of the quality assurance function, when designing or reviewing QAG content, the author must seek the advice of other groups such as engineering, procurement and law. Throughout the drafting, editing and negotiation process, it is important that all parties involved in the QAG consider the purpose and scope of the agreement. When creating a QAG, the author should focus on the purpose and keep in mind that the QAG is neither a supply contract nor a service contract. Rather, it is a delineation of GMP responsibilities and the scope of the specific supply or service for the parties involved. 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). Creating your QIGs is now much easier. After selecting the parties involved in the agreement, all your QAG Required and Default sections will be loaded into the QAG draft for you. All you have to do from there is remove unnecessary sections, modify the content of the other sections to meet the requirements of this unique agreement, add contacts and attachments and the QAG is ready for the next phase. There are regulatory requirements for quality agreements.

Although they are not currently needed by US GMPs for drugs, it is very likely that they will be soon. In 2016, the FDA released the guidance document “Contract Manufacturing Agreements for Drugs: Quality Agreements.” Adding a quality agreement requirement to 21 CFR 211 would push the U.S. to adopt GMPs in accordance with European Union (EU) GMPs and ICH guidelines that the FDA has accepted (see below). What can be excluded from a quality agreement is also worth mentioning. Some points that should never appear in a quality agreement are: quality agreements are specifically 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. Another example: if the quality agreement is “batch log check, five days”, ask for clarification. Is it an MBR or an OPI? Is it five business days or five calendar days? These are details that can make a big difference. When considering the option of a legal-style QAG format, the needs of the receiving group, department or organization should be taken into account and a format that is easy to read, use and understand should be used. If the QAG is a standalone document, a good compromise for all users is a combination of the legal and tabular format, especially a mainly tabular structure, with some sections presented in the Legal Style format. Legal style sections may include, but are not limited to, signature pages, tables of contents, introductory pages, and disclaimer pages.

If the QAG is part of a supply/service contract, much of the information on these legal style pages would obviously already be included in the agreement. 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. »; The use of contractual agreements is an established business practice, but their use in the pharmaceutical sector is a relatively new phenomenon. Their implementation is further complicated by the industry`s regulatory framework. Prior consent under the terms of the relationship is not only a concern of regulators, but also beneficial for the companies themselves. GAQs are useful documents from both a business and A GMP perspective. In order to establish successful business relationships and avoid misunderstandings, GMP responsibilities can be defined between all parties involved in a GAG. The company implementing a quality agreement must first examine its scope. The QAG must specify the products or services for which it is intended. For example, a QAG with a biological agent manufacturer (API) could cover all aspects (cell banks, fermentation and purification) of the production of an ACTIVE INGREDIENT as well as its release tests (but not its stability tests).

A QAG with a supplier can only apply to one item or multiple items. A QAG with a stability storage facility can only include receiving, storing, and shipping samples, but not testing. #Quality agreements can save a #lifescience company a lot of time and money by avoiding misunderstandings, but only if the agreements are timely and thorough and have input from all stakeholders, says @MCMasterControl bit.ly/2DwrlEC Once the draft quality agreement is ready, it can be shared and discussed by all parties involved in different ways, such as telephone, email, fax, Webex conferences, video conferencing and face-to-face meetings. Conflicts and delays in the negotiation process can cost tens of thousands (or even hundreds) of dollars, so good planning is a proactive best practice. At the same time, the process should not be rushed. During negotiations, attention should be paid to the specifics of a QAG. One of the most overlooked sections in the FDA`s guidelines on #quality agreements is the definition section. It is important to know what is meant by each term, especially when entering into contracts with non-US suppliers, he says @MCMasterControl bit.ly/2DwrlEC In the EU, QAG or technical agreements are not just an expectation, but a requirement – a requirement regulated by legislation such as Directives 2003/94/EC Quality agreements should be prepared by the quality assurance (QA) functions of both parties. involve relevant operating personnel, such as manufacturing and laboratory personnel .B. They must be approved by the quality assurance function of both parties and the operations department of both parties.

The legal department may or may not be involved in the quality agreement. The involvement of the Legal Service in the preparatory phase would ensure that the quality agreement complies with the supply agreement. However, this can delay the execution of the quality agreement if the legal department wishes to add unnecessary legal wording that has no place in the quality agreement. .