WHO publishes Annex 2.
I asked Chat GPT to compare the old and new versions and list the major differences. If there is a mistake, I apologize on his behalf. 
Document Identity and Status
- Annex 2 is the newer document (2025), finalized as part of WHO TRS No. 1060.
- QAS/24.943 is the older document (2024), a draft released for public consultation.
Scope
- Annex 2 expands the scope to include not just manufacturers, but also packers and importers/distributors.
- QAS/24.943 focuses more narrowly on manufacturers of excipients, APIs, and FPPs.
Risk Assessment
- Annex 2 introduces periodic reassessment, emphasizes regulatory review before marketing authorization, and includes cumulative exposure considerations.
- QAS/24.943 includes a detailed Ishikawa diagram, root cause prompts, and structured risk assessment questions.
Root Cause Analysis
- Both documents cover similar root causes (e.g., amines + nitrites, water, solvents, equipment), but:
- Annex 2 streamlines and structures the content more cleanly into fewer, broader categories.
- QAS/24.943 has more granular prompts (e.g., cleaning solvents, construction materials, environmental NO₂).
Excipients and Packaging
- Annex 2 includes nitrocellulose ink and PVC as packaging concerns.
- It also highlights excipient batch variability and supplier qualification with validated testing.
- These topics are only lightly touched or implied in QAS/24.943.
Analytical Procedures
- Annex 2 includes a table of methods and notes on false positives from sample prep.
- QAS/24.943 also discusses validation and mentions specific LOQ targets (e.g., <0.02 ppm for high-dose drugs).
Acceptable Intake (AI) Limits
- Annex 2 introduces TD50, less-than-lifetime exposure, and total AI for multiple nitrosamines.
- These concepts are present but less developed in QAS/24.943.