ICH Q7 — GMP for Active Pharmaceutical Ingredients
Q7: what good manufacturing practice means for the QC laboratory — controls, documentation, OOS handling, stability, and reference standards.
Outline and talking points — the full write-up is still to come.
What this page covers
- Where GMP starts in an API process (and the table that tells you).
- The laboratory controls section: approved procedures, instrument qualification and calibration, out-of-specification (OOS) investigations, reference standards, certificates of analysis.
- Documentation and data integrity — ALCOA+, audit trails, contemporaneous records.
- On-going stability program obligations (connects to Q1).
- Q7 as the floor the whole quality system stands on — the Q8–Q12 lifecycle ideas sit on top of it.
Lecture prep — open items
- Anatomy of an OOS investigation (Phase I lab assessment → Phase II).
- A redacted real Form 483 / warning letter citing lab-control failures — discuss.
- What “the data is the record” means in practice for an analyst.