One of the biggest issues facing the pharmaceutical industry and patients today is quality, integrity and security of the pharmaceutical supply chain, preventing contamination (adulteration) and eliminating counterfeits.
A suitable Supplier Qualification Program has hence to be implemented by each user of purchased APIs (or intermediates). A major element of such a supplier qualification program is the Quality Agreement between the manufacturer of the API/intermediate and the buyer or user of the API/intermediate. It increases transparency and traceability by improving the supply relationship between all parties involved in the manufacturing and distribution of APIs and intermediates.
A Quality Agreement under the scope of this guideline is a legally binding agreement that is mutually negotiated and concluded between (the Quality Departments of) API/intermediate manufacturers and their customers. It is intended to define, in a formalised manner, responsibilities relative to quality tasks to assure the manufacture and supply of safe materials (APIs or intermediates) acceptable for pharmaceutical use.
Legal Requirements
Quality Agreements have become a common tool in our business and are intensively demanded by the authorities to be implemented. They have increasingly been referred to or described in international guidelines.
Written contracts/agreements defining the responsibilities and communication processes for quality-related activities of the involved parties are mandatory for “contract manufacture” (see EU GMP Guide Part I, chapter 7, and ICH Q7 Guideline, chapter 16) or “outsourced activities” (see ICH Q10 Guideline, chapter 2.7), respectively. In principle, it is the responsibility of the contract giver to request the closure of such a contract/agreement with its contract acceptor(s).
In the United States, Quality Agreements are simply assumed but not necessarily a (legal) requirement. The Food and Drug Administration (FDA) issued its final guidance for industry on Quality Agreements in the pharmaceutical industry (Contract Manufacturing Arrangements for Drugs – Quality Agreements). This guideline covers “manufacturing activities of the parties involved in contract drug manufacturing subject to CGMP”, and it makes reference to ICH Q7, chapter 16.11.
While the FDA guidance document is focused on contract manufacturing, there is no such guideline for requirements of agreements for purchased APIs. In its guide the FDA only encourages “entities that engage in manufacturing related solely to drug distribution to follow the recommendations in this guidance document, as appropriate”.
Furthermore, the FDA states that “Quality Agreements should not cover general business terms and conditions such as confidentiality, pricing or cost issues, delivery terms, or limits on liability or damages”. The agency recommends that “Quality Agreements be separate documents, or at least severable, from commercial contracts such as master services agreements or supply agreements”.
1. Introduction/Purpose/Scope
2. General Provisions
3. Quality Responsibilities
4. Signatories
5. Contacts
6. List of Appendices
7. History / Change Log
