APIC Quality Agreement Guideline: Update published

Recommendation

23/24 October 2024
Vienna, Austria

27th APIC/CEFIC Global GMP & Regulatory API Conference - in Vienna or online

The first version of the document "Quality Agreement Guideline & Template" was published in 2009, updated in 2017 and has now been revised again. Version 3 of the guideline was published in January 2024 and is now available on the APIC (Active Pharmaceutical Ingredient Committee) website in the "Publications" tab.

The APIC document is divided into two parts, "Guideline & Template", whereby all general points on the topic of Quality Assurance contracts for active substances are listed first, before the draft of the same is presented. The APIC document also contains a topic-specific glossary.

Revisions and additions have been made in both parts and are listed below:

1) Guideline

a. Chapter 3.2 Scope: The addition regarding distributors was made here and it was pointed out how the draft contract can be used in the event that distributors are involved.

b. Chapter 8 Glossary: The glossary has been shortened and all long-established terms have been removed. In addition, the sentence "The glossary or parts of it may be included in the template (under I.4 Definitions), if requested." was added to the "Note".

c. Chapter 10 History / Change Log: This chapter has been newly added and now represents the document history. It lists the versions of the guideline and the template as well as the individual changes and additions.

2) Template

a. Chapter II General Provisions: This provided additional information in paragraph II.2 and presented a dispute resolution procedure in paragraph II.7.

b. Chapter III Quality Responsibilities: Points 9.02, 12.06, 13.02 Form for the PQR Summary, 22.08 and parts of point 6 Data Integrity have been added.
Points 1.03, 2.01, 4.01, 5.01, 11.04 to 11.01, 12.07 and 19.04 have been revised or supplemented.

Please see the APIC website for the Guideline as well as the draft contract and the PQR summary.

As always, new guidance documents of the APIC will be discussed and presented during the "27th APIC/CEFIC Global GMP & Regulatory API Conference", which will take place on 23/24 October 2024 in Vienna, Austria and online.