Hardware Podcasts

010 - "Don't Make Assumptions" with David Simoens

Let's Combinate · 8 Dec 2021 · 1h 13m

What this episode covers

David Simoens, COO of cGMP Consulting Group, explains how a risk-based approach can streamline commissioning, qualification, and validation (C&Q) in pharmaceutical manufacturing. He details the transition from traditional, repetitive testing to leveraging data from Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) through rigorous User Requirement Specifications (URS) and risk assessments. Simoens highlights common pitfalls, such as poorly written 70-page URS documents and inadequate debugging at the vendor site, which lead to significant project delays and cost overruns. He emphasizes the importance of using tools like FMEA and ISPE guidelines to identify critical aspects early, ensuring that testing is performed once and leveraged through to Performance Qualification (PQ).

Most relevant to

companies scaling up

Topics

Mentioned

Companies
cGMP Consulting Group
Also
ISPE, ASTM E2500, PDA, ICH

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