Overall, the best way to avoid inspection observations that may lead to a warning letter is to initiate quality agreements that use the recommendations of the current quality agreement or outsourcing policies of health authorities, which reflect CGMps and are part of an effective pharmaceutical quality system. 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. In the draft guidelines, the FDA defined an owner as each party that “introduces (or causes) the introduction of a drug into intergovernmental commerce. As we said in our previous article, this definition was so broad that it seemed highly unlikely that the FDA would actually intend to apply the guidelines to all entities that would meet that definition (for example. B distributors). Not only did it seem illogical to require distributors or other “owners” in effluents to be responsible for certain non-delegable cGMP requirements, such as product release, but it should also have resulted in the repeal of Section 303 (c) of the Act authorizing down stream companies to rely on written product warranties from Up Stream manufacturers. 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. In the eyes of the FDA, any activity that is not documented may as well not have occurred. A quality agreement gives the contracting establishment and the owner the opportunity to define the expectations of those who verify and approve quality documents. Protocols should be described for changes to standard operating procedures (SOPS), manufacturing documents, specifications, validation documentation, and all other essential documents relating to products or services provided by the contracting body. The role of both parties in the development and maintenance of original documents or authentic copies compliant with the CGMP must be indicated.
The agreement should also clarify how these recordings are easily made available for consultation. It is advantageous to include a statement indicating that electronic records are stored in accordance with CGMP and kept in a searchable condition during the required registration periods, in accordance with FDA requirements. Manufacturing quality agreements are comprehensive written agreements between the drug manufacturing parties that define each party`s manufacturing activities and determine how each party respects cmIM. 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.