APIC: Template for RSM Quality Agreements

Since December 2025, the first version of the 'Quality Agreement Template for Regulatory Starting Materials ('RSMs') and Critical Materials between company 'x' and company "y"' has been available on the APIC website under the 'Publications' tab. This first version, which according to the document history is dated September 2025, was initially created by the APIC Task Force 'Supplier Management' and is based on the APIC Guidance Document 'APIC Quality Agreement Guideline & Template', which was last updated in 2024. The 'Quality Agreement Template for Regulatory Starting Materials ('RSMs') and Critical Materials between company 'x' and company "y"' is listed as 'Annex 1 - Best practices guide for managing suppliers of API manufacturers'.

As a suggested table of contents for a Quality Agreement for Regulatory Starting Materials (RSMs), this template lists the following points:

Cover Page
I. Introduction / Purpose / Scope
  I.1 Parties to the agreement
  I.2 Products and production process covered by the agreement
  I.3 Site(s) involved
  I.4 Definitions and abbreviations and references (optional)
II. General Provisions
  II.1 Effective date
  II.2 Term of agreement
  II.3 Related agreements
  II.4 Amendments
  II.5 Confidentiality (optional)
  II.6 Resolution of quality disputes (optional)
  II.7 Choice of law (optional)
  II.8 Survival clause (optional)
III. Quality Responsibilities
  1. Applicable GMP Standard / Regulatory Compliance
  2. Change Control
  3. Audits
  4. Specifications
  5. Buildings and Facilities
  6. Laboratory Controls
  7. Product Release
  8. Product Shelf life
  9. Certificate of Analysis / Conformance
  10. Certificates, Statements and Declarations
  11. Process Robustness Monitoring
  12. Documentation
  13. Materials for manufacture of PRODUCT
  14. Suitability of process / systems
  15. Reprocessing / Reworking
  16. Contamination prevention
  17. Sub-contracting
  18. Packaging
  19. Labelling
  20. Storage and Distribution (incl. Supply Chain Traceability)
  21. Deviations / OOS
  22. Complaints
  23. Blending of production batches into commercial batch
IV. Signatories
V. Contacts
VI. List of Appendices

Compared to the general Quality Agreement Template, paragraph 3, Quality Responsibilities, is somewhat shorter and includes points specific to RSMs. These include, for example, sub-points 5, 8, 11, 14, 16 and 23.

The new template for RSM quality agreements can be found as 'Annex 1 - Best practices guide for managing suppliers of API manufacturers' in the 'Publications' tab on the APIC website.