{"podcast":{"title":"Let's Combinate - Drugs + Devices","slug":"let-s-combinate-drugs-devices-4474248","podcast_index_feed_id":4474248,"rss_url":"https://anchor.fm/s/6770b9a0/podcast/rss","website_url":"https://letscombinate.com","image_url":"https://d3t3ozftmdmh3i.cloudfront.net/staging/podcast_uploaded_nologo/17254408/17254408-1735275370987-64c671ec88d89.jpg","author":"Subhi Saadeh","episode_count":261,"summary":"Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!","last_synced_at":"2026-09-07T22:17:41.545168+00:00","page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248"},"episode":{"title":"234 - ICH Q7: The GMP Framework for API Manufacturing","slug":"234-ich-q7-the-gmp-framework-for-api-manufacturing","published_at":"2026-04-15T10:00:00+00:00","page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/234-ich-q7-the-gmp-framework-for-api-manufacturing","show_page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248","url":"https://podcasters.spotify.com/pod/show/letscombinate/episodes/234---ICH-Q7-The-GMP-Framework-for-API-Manufacturing-e3htt99","audio_url":"https://anchor.fm/s/6770b9a0/podcast/play/118469353/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-3-14%2F422086151-44100-2-4a12d8e895e3f.mp3","summary":"In this episode of Let’s Combinate, Subhi breaks down ICH Q7. Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturing. This episode walks through how to actually read it and what matters in practice. Covers: • Scope and where GMP begins • API starting material (core concept) • GMP scaling across the process (Table 1) • Quality unit and QMS expectations • Production and in-process controls • Validation and change control • CMOs and supply chain • Clinical trial flexibility (Section 19) Timestamps 00:00 Intro 00:13 What Q7 Covers 01:23 Scope and GMP Start 02:19 API Starting Material 04:05 GMP Scaling (Table 1) 05:30 Quality and QMS 06:58 Production Controls 08:26 Validation 09:46 Change Control 10:27 CMOs / Supply Chain 12:11 Clinical 13:12 Takeaways https://database.ich.org/sites/default/files/Q7%20Guideline.pdf Subhi Saadeh is the Founder and Principal at Let’s ComBinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.","meta_description":"In this episode of Let’s Combinate, Subhi breaks down ICH Q7. Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturing. Th…","key_points":[],"chapters":[],"topics":[],"duration_seconds":835,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/let-s-combinate-drugs-devices-4474248/episodes/234-ich-q7-the-gmp-framework-for-api-manufacturing/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/234-ich-q7-the-gmp-framework-for-api-manufacturing.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}