The FDA encourages contract manufacturing parties to implement quality management practices. These guidelines build on the quality management principles and recommendations set out in the Employment and Quality Guidelines to illustrate key elements of the design and implementation of quality agreements that describe and support manufacturing agreements. Part of the agreement should take into account a specific reflection on the different products. In addition, it is necessary to define how owners pass on knowledge, such as . B, from product and process development information to contract entities to ensure that manufacturing is geared towards CGMP. 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. On the other hand, the new guide gives a general overview of the areas to be included in a quality agreement. It contains sections relating to manufacturing activities: there are four types of quality agreements: manufacturing, supplier, supplier and quality of service agreements, which are tailored to the relevant aspects of each type of relationship. Whenever a contractor or ORGANISATION is used, including agreements between different departments of the same company, regardless of the physical location of the parties involved, a quality agreement should be reached.
The agreement should cover all aspects of the project affecting the identity, quality, safety, efficiency and purity of a product. Items that may affect the contractor`s or client`s compliance status should also be included. A real example of compliance [FDA] 483 in quality agreements is a contract verification body that indicates that it does not comply with a quality agreement on the destruction of the remaining samples with the approval of the contracting entity. This relates to the importance of defining clearly defined roles, respecting roles within an agreement and matching CGMP`s expectations. According to the FDA, a quality agreement is a comprehensive written agreement between the parties involved in the manufacture of the contract, which defines and defines each party`s production activities with respect to CGMP compliance. The agreement should make it clear whether the owner or contracting body (or both) is engaged in certain CGMP activities. 1. When a separate contract laboratory is involved, all relevant roles and responsibilities must be defined. The quality agreement should explicitly state what data is transmitted and how it is disseminated. Robert Iser, Vice President of PAREXEL Consulting, discussed with Pharmaceutical Technology Europe the role of quality agreements in outsourcing.
The FDA does not have a specific policy for quality agreements between medical device companies and CMOs that provide them with services. However, FDA guidelines state that quality agreements should cover activities under Category 21 CFR Part 820, the Quality Assurance Regulation (QSR) for medical device companies, “if applicable.” Given the inclusion of Part 820 in the guidelines, a quality agreement between a medical device company and an CMO should, to varying degrees, apply to the following aspects, depending on the nature of the relationship between the two parties and the products and services concerned: the FDA`s current position on quality agreements is outlined in the “Contracting Manufacturing Arrangements for