„As an external consultant,“ Minsk explained, „I focus on the FDA. I have other partners who take care of the business. I look at a lot of quality agreements. I am often brought in when we talk about a nine-inning ball game, usually in the eighth inning of the ball game. Sometimes it`s the floor of the 9. When companies sign the quality agreement, „everyone is happy. It`s like newlyweds. But then reality sets in, and inevitably, although no one is to blame, things happen,“ Minsk commented. Minsk shared part of the FDA`s quality agreement guideline, which included important points that needed to be strengthened (Figure 1). The scope of the quality agreement should cover several compliance activities, such as.B.
Qualification, calibration and maintenance of analytical instruments and manufacturing equipment; Validation of computer systems, analytical methods and manufacturing processes; the specifications used to pass or fail analytical tests; handling, storage and preparation of supplies; receipt, analysis and communication of samples; collection and management of laboratory records; and variance management and change control. In their experience, quality and regulatory staff are often called in the final rounds – perhaps in the 7th or 8th round – and the sales team or business development team may have already begun negotiations and almost completed the deal. Quality and regulation are often introduced very late, although they are ultimately responsible for most of the provisions of the quality agreement. The content of group agreements depends largely on the nature of the controlled transaction and the jurisdictions in which the controlled transaction(s) take place. Complex controlled transactions, such as intellectual property licensing, require detailed contracts. Contracts for simple controlled transactions, such as . B the provision of administrative services, can remain simple. 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. 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.“ It shows that these processes must include quality risk management and include critical activities, such as: The following example illustrates what can be done without transfer pricing agreements: In addition, the European guidelines for BGMs state that „the contract must clearly describe who performs each stage of the outsourced activity.
B, for example, knowledge management, technology transfer, supply chain, outsourcing, quality and procurement of materials, testing and release of materials, production and quality control (including process control, sampling and analysis). A quality agreement (also known as a technical agreement and in this context, the terms are interchangeable) is a written contract that is required when a company relocates an activity in accordance with Good Manufacturing Practices („GMP“) guidelines. It defines the responsibilities of the various parties with regard to GMP. Intercompany agreements are fundamentally different from third-party contracts (also known as commercial contracts). A business-to-business agreement is signed by two companies that are part of the same group. Presumably, they have the same goal: to increase the group`s revenues. They have the freedom to organize the transaction as they see fit, and it is unlikely that there will be a dispute. At first glance, the business-to-business agreement is a formality. Apple`s CEO, based at the US headquarters, is strategically advising an Apple Ireland operating company. It is common for the trade agreement and the quality agreement to contain provisions on the same subject, such as .B rights. An intra-group agreement (also known as an „intra-group agreement“ or „transfer pricing agreement“) is a contract (signed) between two or more affiliates. Such a contract governs the terms (T&C) of controlled transactions, such as.
B the supply of goods or services from an affiliate to another affiliate. The following example illustrates what can happen without transfer pricing agreements: Intercompany agreements are contracts between two or more companies or divisions owned by the same parent company.3 min Read Fda recommends that the quality agreement include the following provisions: The guidelines require owners to review and approve most changes before they are implemented. However, in some circumstances, contractors may make changes without notifying the owner. A quality agreement should define how all these changes are made and managed. A quality agreement should specify which party defines component specifications and which part defines the processes for auditing, qualifying and monitoring component suppliers. It should also be specified who will carry out the tests or sampling necessary to comply with GMP. The staff of the contracting entity should be properly trained and monitored in order to ensure performance in accordance with the quality system. .