Pharma Contract Manufacturing: Managing Quality and Technical Agreements

The identification and arrangement with a contract service provider (CSP) for the manufacture or testing of an early or late stage pharma product provides many opportunities as well as pitfalls. The reasons for turning to a CSP frequently are due to resources, either capital or monetary, headcount or level of expertise, technical capabilities or most commonly TIME. Meeting timelines and doing it right in the development and realization of a pharma product can be at loggerheads with one and another and turning to a CSP can be the answer.

Identification of the right CSP involves a business and cGMP compliance assessment that takes into account the costs, timing, capabilities, communications, and client and regulatory inspection history. Identifying all the areas that need to be addressed from the project, cGMP quality and technical perspective seems a daunting task and the establishment of a Quality or Technical Agreement (Q/TA) along with the business agreement can address these issues. Use of a QTA has its origin from the EU cGMPs, volume 4 and chapter 7 and has been promulgated in recent times by FDA and ICH guidance. A Q/TA is separate but complementary to and. in matters relating to cGMP compliance and control, takes precedence over the business contract. The contract provider (client) and contract acceptor (CSP) jointly develop and agree upon the terms of the Q/TA. The key premise for the establishment of this living document is twofold: the client has ultimate responsibility for the safety and quality of any product or results provided by the CSP from the patient and regulatory compliance perspective, while the CSP must assure not only the client but also the regulatory authorities that they are entirely capable and compliant to provide the service to the relevant standards.

The scope of the Q/TA spans all aspects for the service provided, usually either production or testing or both. Areas that are typically addressed cover regulatory compliance, frequency and nature of communications, stages of manufacturing, development (e.g. validation) and/or testing, nature and qualification of equipment, systems and facilities, testing and standards, document control and provision of data, control of manufacturing, testing procedures and records, change control and exception management (e.g. deviations and out of specification/trend results), investigations, training, client auditing and regulatory inspections, dispute resolution and product control.

These as well as other specific items are identified as to the responsible party (client or CSP) and clearly presented in the document. The Q/TA should be formally reviewed and approved by both quality and operations or laboratory organizations and frequently is also the subject of a legal review. It is a living document and should be under the respective document control systems and trained on to the appropriate members of the both organizations across, QA, QC, and operations. A periodic review of the Q/TA should be established and coordinated by both parties to assure all areas of development and realization of product or testing are the same or if changed are accurately reflected and approved. The use of a Q/TA when using a CSP through the development, approval and commercialization is an invaluable tool to achieve a cost-effective, quality product that meets or exceeds standards.

Why should you Attend: Biopharmaceutical companies are increasingly under greater cost and time pressure for the development and realization of new pharmaceutical products yet also need to assure that their products meet more comprehensive product safety and quality standards. One path followed by many pharma companies, either startups or established companies, is the use of contract manufacturing and/or testing facilities. Though offering a cost-effective solution, issues relating to cGMP compliance, timing, capabilities and expertise and most importantly communication can and frequently do arise and must be addressed.

A tool to mitigate these and myriad of other issues arising in partnering with a contract service provider (CSP) is the development and use of a Quality Agreement (also known as a Technical Agreement). A Quality Agreement can address who, what, where, when and how for realization of a product or test performance. It allows for the identification and mitigation of potential risks in areas of manufacturing, validation, testing, documentation, auditing and inspections, to name a few. Though not formally required by US or European regulators until commercial manufacture the early implementation, concurrent with drug development, makes sense from both a business and cGMP compliance perspective and is increasingly required as part of the contract establishment process.

Areas Covered in the Session:

• Why Use a Contract Service Provider
• Selection of a Contract Service Provider
• The Business Agreement vs. the Quality/Technical Agreement
• Regulatory Basis
• What’s In the Quality/Technical Agreement and Why
• Control and Management of the Quality/Technical Agreement

• Director Quality Assurance
• Manager Quality assurance
• Quality Assurance Specialist
• Project Manager
• Production/Operations Director
• Contract Manager