Quality Technical Agreements (QTAs) are not just a nice-to-have; there is a regulatory requirement to have them established!
QTAs are established with manufacturers, suppliers and service providers to obtain written agreements of the details of activities to be provided and the associated requirements and controls. Each agreement type should be tailored to address the relevant aspects of the particular type of relationship.
Manufacturing quality agreements are established between parties involved in the contract manufacture of medicinal products; such an agreement will define and establish each party’s manufacturing activities in terms of how each party will manufacture product in compliance with cGMPs and the Marketing Authorisation. Supplier quality agreements on the other hand are established to define the terms and conditions relating to the quality of materials or services supplied to a manufacturing facility that are used in the products or in the production of products. Service quality agreements, as their name indicates, define the terms and conditions relating to the quality of services supplied to a manufacturing facility that are used in the production of products. Any outsourced contract arrangement should have an associated quality agreement; this includes arrangements between different divisions of the same company, or between sister companies.
QTAs must be written in such a manner to ensure no ambiguity and that roles and responsibilities, including communication channels and timelines, are clear and understood by both parties. A procedure should exist on the requirements for QTAs within your organisation. This should define the review period of all QTAs which should be assessed during PQS management reviews, after which updates are processed as applicable.
The ICH Guide clearly states that “there should be a written and approved contract or formal agreement between the contract giver and the contract acceptor that defines in detail the GMP responsibilities, including the quality measure of each party”. In addition, Eudralex provides “A Contract should be drawn up between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities and communication processes relating to the outsourced activities. Technical aspects of the Contract should be drawn up by competent persons suitably knowledgeable in related outsourced activities and Good Manufacturing Practice.” In addition, the GMP guidelines also state that “The Contract should describe clearly who undertakes each step of the outsourced activity, e.g. knowledge management, technology transfer, supply chain, subcontracting, quality and purchasing of materials, testing and releasing materials, undertaking production and quality controls (including in-process controls, sampling and analysis).”
Ensure all aspects that affect the identity, quality, safety, potency and purity of a product are included within the agreement. As a minimum, your QTA should include:
- Purpose & Scope
- Roles and Responsibilities (including contact details)
- Dispute Resolution
- Communication Methods
- Use of third-parties, if relevant
- List of products associated with the agreement
- Change & Revisions
What are the key considerations when establishing a QTA?
1. Involve cross-functional personnel to review the document.
While the QTA should be prepared by the QA team, involving manufacturing, laboratory, supply chain and legal personnel for example is key to ensuring the document meets the appropriate requirements for all stakeholders.
2. Develop a framework checklist.
This framework document should include all key aspects of the QTA document and a review of the template against this checklist will identify gaps immediately. Forgetting to include a key point at the negotiation stage could lead to significant problems further down the track!
3. Examine the definitions and key terms for clarity.
When is a change a major change? Do all deviations need to be endorsed by both quality teams? How are out of specification results handled? Ensure the document is unambiguous in nature so roles and responsibilities are clearly defined.
4. Ensure the QTA is aligned with the Master Services Agreement (MSA) or Supply Agreement.
Whilst the MSA describes the financial and legal interactions, it does overlap with the QTA in operational areas and deliverables. Review both documents alongside each other to ensure no conflict exists.
5. Do a dry-run!
During the negotiation stage, test the QTA against a previous experience to see if you have sufficiently documented responsibilities, timelines, requirements etc. and assess if the QTA is adequate. For example, if notification of a deviation requires acknowledgment, agreement, approval- ensure this is stated clearly within.
Aside from being a regulatory requirement, quality technical agreements reduce errors, timelines and ultimately cost. Remember, just because you are outsourcing an activity, this does not relieve you of the responsibility associated. Leave nothing to chance and ensure your QTAs are in place today!
If you would like to get in touch with MIAS Pharma, please email us or call us on +353 (1) 846 3605.
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