APIC Quality Agreement Guideline and Template v03: A Useful Tool for API Suppliers and Customers

Click here to download the template on the APIC website. Note: click on the document title, otherwise you will only download the document's annex.

In early 2024, the Active Pharmaceutical Ingredients Committee (APIC) released a new version of the APIC Quality Agreement Guideline & Template (version 03, January 2024). This guideline—developed by APIC—helps both API producers and their (pharmaceutical) clients in drawing up clear Quality Agreements.

The Core: Harmonization and Transparency

A Quality Agreement sets out the arrangements and responsibilities in terms of quality, GMP, and compliance between the supplier and the customer. The APIC guideline focuses specifically on the relationship between API manufacturers (or their distributors) and pharmaceutical companies. By using a standardized template, you can save time and ensure consistency during negotiations. Legal departments only need to review the document instead of rewriting it entirely, which can significantly shorten the overall turnaround time.

Key Points

1. Scope and Boundaries The template focuses solely on the API supply chain toward the customer (including any distributors). Raw materials purchased by an API manufacturer fall outside of its scope.

2. Section 4: Legal Requirements This section outlines the “why” of Quality Agreements. While it offers little new to those familiar with GMP, it provides a handy, concise summary of, among others, EU GMP, ICH Q7, and FDA cGMP. It’s useful reference material for both experienced and less experienced quality professionals.

3. Template for Negotiations The new version (v03) contains a detailed, clearly structured sample text for drafting your own Quality Agreement. This allows both operations and legal teams to reach consensus quickly. Since the MAH (Marketing Authorization Holder) and the QP (Qualified Person) ultimately remain responsible, it is advisable to critically compare the template against GMP Part I (EU). The guideline itself does not explicitly mention GMP Part I, so you’ll need to do your own checks—particularly if you plan to use it in the EU GMP context. The U.S. FDA cGMP is extensively cited.

4. Points of Attention

   • OOS Procedure (Out of Specification)

     The template mentions a basic framework but is not as extensive as some EU GMP expectations. It is wise to align your own OOS procedure with this.

   • Biological APIs

     There are no specific references to Biological APIs. Those working with such substances will need to consult additional guidelines.

   • Distributors

     Even if there are distributors between the supplier and the end customer, this document provides useful guidance. The guideline suggests options for 3-way agreements or separate contracts between the distributor and the end customer.

Practical Benefits

• Time Savings

  Working with a standard template minimizes the number of versions and review rounds.

• Less Legal Hassle

  The substantive quality arrangements are separate from commercial terms, meaning only the “Quality” section needs to be scrutinized.

• Simplified Compliance

  A structured and consistent approach clarifies roles and responsibilities, especially for organizations dealing with multiple customers/suppliers and thus numerous Quality Agreement templates.

Conclusion

The APIC guideline and its accompanying template serve as a valuable roadmap for any pharmaceutical organization that procures or produces APIs—or is planning to. They facilitate swift negotiations and aim to simplify compliance. Nevertheless, it remains important to check the template against your specific quality management system and local (EU) GMP requirements—especially for matters like OOS and QP responsibilities.

With this new version, APIC continues to promote harmonization and efficiency across the global API chain. A well-implemented Quality Agreement not only saves time but also provides a solid foundation for sustainable collaboration between API suppliers and their customers.