Hardware Podcasts

234 - ICH Q7: The GMP Framework for API Manufacturing

Let's Combinate · 15 Apr 2026 · 13m

What this episode covers

Subhi Saadeh, Founder of Let’s ComBinate, provides a detailed walkthrough of ICH Q7, the GMP framework for Active Pharmaceutical Ingredient (API) manufacturing. He explains that unlike other guidelines, Q7 covers the full lifecycle from API starting materials through production, validation, and quality management systems (QMS). Key decisions discussed include defining the start of GMP via Table 1, establishing independent quality units, and managing Contract Manufacturing Organizations (CMOs) with strict audit rights. The episode highlights the flexibility allowed for clinical trial APIs (Section 19) and the scaling of controls as processes mature from early synthesis to final packaging.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Let’s ComBinate, Pfizer, Gilead, Baxter
Also
ICH Q7, ICH Q11, ICH 15378

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