simpl.
Sign in
Life-Sciences eQMS 20 items

API / Excipient Supplier Audit Checklist

Guides an on-site or remote GMP audit of an active pharmaceutical ingredient or excipient supplier to support material qualification. Use for initial qualification and periodic requalification audits.

ICH Q7EXCiPACT / IPEC GMP21 CFR 211.84ICH Q9

Free PDF · enter your email to download.

Quality Management System

  • Is an independent quality unit in place with authority over release and quality decisions? *
  • Are SOPs controlled, current, and followed with a document management system? *
  • Is a deviation, CAPA, and change control system implemented and effective? *
  • Are management review and self-inspection (internal audit) programs in place? *

Facilities, Equipment, and Utilities

  • Are facilities designed and maintained to prevent contamination and mix-ups? *
  • Is equipment cleaning validated for shared/multi-product equipment? *
  • Are utilities (water, HVAC, compressed gases) qualified and monitored appropriately for the material? *
  • Is equipment calibration and preventive maintenance documented? *

Materials Management and Production

  • Are incoming materials tested/verified and released before use? *
  • Are batch production records complete, contemporaneous, and reviewed? *
  • Is in-process control and yield reconciliation performed? *
  • Is traceability maintained from starting materials to finished API/excipient? *

Laboratory Controls

  • Are analytical methods validated or verified for their intended use? *
  • Is an OOS/OOT investigation procedure implemented? *
  • Is a stability program in place to support retest/expiry dates? *
  • Are reference standards qualified and controlled? *

Change Notification and Audit Closeout

  • Does the supplier commit to notifying customers of changes affecting quality? *
  • Is subcontracting/outsourcing of GMP activities controlled and disclosed? *
  • Are audit findings classified by risk and a CAPA response requested? *
  • Record the overall supplier qualification recommendation.

Download the full API / Excipient Supplier Audit Checklist checklist

Get it as a clean, printable PDF — free.