Supplier Quality Agreement Pharmaceutical

Filed under:Uncategorized — posted by admin on December 18, 2020 @ 11:36 am

PTE: What are the main aspects of a quality agreement? Iser: The best way for pharmaceutical companies and contract manufacturers to create quality agreements that will clearly describe each company`s responsibilities 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. Supplier and supplier quality agreements define the quality conditions of materials or services provided at a production site and used in products or product manufacturing. Service quality agreements define the quality conditions of services provided at a production site and used in the manufacture of products. There are four types of quality agreements: manufacturing, supplier, supplier and quality of service agreements, which are tailored to the relevant aspects of the type of relationship. To learn how to optimize the coordination of quality agreements and other order manufacturing functions with digital tools, read the trend letter “3 Ways Contract Manufacturing Organizations Are Looking to Digital Technology to Improve Collaboration.” The FDA guidelines also state (in case examples) “Regardless of who the products are tested, the owners` quality units are ultimately responsible for manufacturing the products in accordance with CGMP. A quality agreement will not change that. The FDA could name the owners… for non-assessment, qualification, review and control of their contractual bodies. Manufacturing quality agreements are comprehensive written agreements between the parties involved in the manufacture of drugs that define and define each party`s production activities, in accordance with those that comply with the PMCs. The control of suppliers such as Contract Manufacturing Organizations (CMO) has always been a requirement of the FDA and the EU. With the issuance of these new regulatory documents, it is expected that there will be written documentation of this review. Proof of this control may be presented to FDA/EU inspectors in the form of a specific quality agreement to a given CMO.

PTE: What is the responsibility of a pharmaceutical company when it comes to ensuring the quality and safety of products or ingredients manufactured in a contract facility? 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. Quality agreements are not only good business practices, but also regulatory requirements. ICH Industry Guide Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients recommends that owners evaluate contract facilities to ensure that contract sites meet CGMP for certain operations.

Written agreements should also set out considerations relating to subcontracting.

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image: detail of installation by Bronwyn Lace