PTE: What are the FDA`s expectations for quality agreements? PTE: What mistakes do companies make in establishing quality agreements? The scope of the quality agreement should include several compliance activities, such as qualification, calibration and maintenance of analytical tools and manufacturing equipment; Validation of computer systems, analysis methods and manufacturing processes; The specifications used to pass or fail to pass analytical tests Processing, storing and preparing; Receiving, analyzing and communicating samples Collecting and managing laboratory records Gap management and change control. Another major problem with the board is their lack of specificity. The debate on the applicability of international standards of good practice ICH Q7, Q9 and Q10 tends to remain at a high level, rather than highlighting the key elements of the international guidelines that need to be addressed. The ICH guidelines do an excellent job in developing the problem, but they do not contain practical approaches to the application of the concepts they convey. The FDA`s new guidelines would have been an excellent opportunity to provide examples of how these approaches should be articulated as part of the quality agreement. Iser: Although a pharmaceutical company (or an application sponsor or market authorization) is ultimately responsible for making available products available to patients and nurses meeting quality and safety expectations, ensuring the quality and safety of products and ingredients manufactured in a contract facility is a shared responsibility between the pharmaceutical company and each licensed facility. Both parties must meet the expectations set out in the relevant rules and guidelines to ensure that products are manufactured in accordance with current good manufacturing practices (CGFs), meet the required quality standards, and are safe and effective throughout the product lifecycle. The ICH`s industry guide Q10 Pharmaceutical Quality System recommends that the owner, as a member of a pharmaceutical-grade system, ultimately be responsible for ensuring that “processes are in place to ensure control of outsourced activities and the quality of materials purchased.” It shows that these processes involve quality management and critical activities such as Iser: Iser: The best way for pharmaceutical companies and contract manufacturers to enter into quality agreements that will clearly describe the responsibilities of each company is to follow the recommendations regarding the roles and responsibilities contained in the current guides. The Agency`s current documents clearly set out expectations for documenting roles and responsibilities directly related to the responsibilities of the quality unit contained in the PMCs; and aspects of the pharmaceutical quality system contained in health authority guidelines and ICH guidelines. Cooperation is essential to any successful business partnership, which is why it is important for owners and contractors to develop written and oral communication protocols. A quality agreement should define all manufacturing roles and activities and establish appropriate contact staff for each organization.