Let's Combinate - Drugs + Devices

PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualification and validation are approached today.

In this video, I walk through where PI 006-4 fits within the broader GMP framework, how it relates to EU Annex 15, and the sections I think are most worth paying attention to.

A few of the major themes include a much stronger emphasis on quality risk management and lifecycle thinking, more explicit expectations around statistics, sampling, variability, and process capability, a move away from treating three validation batches as a default answer, and clearer discussion of traditional validation, continuous process verification (CPV), hybrid approaches, and ongoing process verification (OPV).

The goal isn't to suggest that all of these concepts are brand new. Many have been developing across the industry for years. What is interesting is seeing how PIC/S has now pulled them together into an updated recommendation that reflects current qualification and validation thinking.

Chapters

00:00 Big Update Overview
01:02 Who PIC/S Serves
01:28 Annex 15 Relationship
02:12 Scope and Exclusions
02:39 Why Update Now
04:05 Four Key Changes
04:47 Risk and Lifecycle Shift
06:43 Statistics and Sampling
07:48 Rethinking the Three-Batch Rule
08:30 Ongoing Process Verification
09:11 Traditional, CPV and Hybrid Approaches
10:45 Key Takeaways

About Subhi
Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

Connect With Let’s Combinate
Website:
https://www.letscombinate.com
Schedule an intro call:
https://calendly.com/letscombinate/let-s-combinate-intro-session
LinkedIn:
https://www.linkedin.com/in/subhi-saadeh-1169aa21
Apple Podcasts:
https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792
Spotify:
https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2
Documents Discussed
PIC/S PI 006-4 — Recommendations on Qualification and Validation (2026)
https://picscheme.org/docview/11277
PIC/S PI 006-3 — Validation Master Plan, IQ/OQ, Non-Sterile Process Validation & Cleaning Validation (2007)
https://picscheme.org/docview/3447
EMA / PIC/S Concept Paper — Revision of Annex 15: Qualification and Validation (2026)
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation_en.pdf
PIC/S Publications Page
https://picscheme.org/en/publications

Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may need to improve.

In this video, I share the lessons I learned as I moved from being audited and supporting audit rooms to conducting audits as a certified lead auditor:

1) Audit the system, not the person: The goal is to understand how the system operates, not to catch an individual making a mistake.
2) Look for patterns, not isolated errors: One typo is different from a recurring or systemic problem, unless the individual event is critical.
3) Scope the audit before you start: The objective, criteria, time, resources, and agenda need to align before the audit begins.
4) Technical expertise is not the same as audit skill: Auditing requires its own tools, tactics, strategies, interviewing skills, and qualification.
5) Lower the temperature to get better evidence: People communicate more clearly when the auditor reduces unnecessary anxiety, although assertiveness is sometimes necessary when information is being withheld.

Chapters
00:00 Audits Aren’t Gotchas
00:38 Audit the System, Not the Person
03:16 Look for Patterns, Not Isolated Mistakes
05:27 Set a Clear Audit Scope
08:21 Auditing Is Its Own Skill and Being Technical Helps
11:11 Lower the Temperature and Be a Human

About Subhi
Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical-device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

Learn more:
https://letscombinate.com/
subhi@letscombinate.com

Connect with Subhi on LinkedIn:
https://www.linkedin.com/in/subhi-saadeh-1169aa21

What is a Quality Unit and how do Quality Assurance and Quality Control fit within it?

In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, medical-device, and combination-product companies. We’ll look at the Quality Unit’s major responsibilities, why QA is generally system- and process-focused, why QC is generally testing- and product-focused, and why the organizational structure varies between companies.

CHAPTERS

00:00 What is a Quality Unit?
01:18 The Quality Unit as the umbrella function
01:55 Three major Quality Unit responsibilities
03:08 What functions may sit within Quality
04:08 Establishing, operating, and releasing
04:37 Quality Assurance vs. Quality Control
05:38 Common QA responsibilities
06:16 Common QC responsibilities
06:53 Why pharma and device companies look different
07:32 Drug vs. device terminology
08:06 How QC supports product release
08:26 Final QA vs. QC summary

KEY TAKEAWAYS

• The Quality Unit provides overall quality oversight.
• QA primarily focuses on systems and processes.
• QC primarily focuses on inspection, measurement, and testing.
• QC testing provides essential evidence supporting product disposition.
• Exact responsibilities and reporting structures vary by company and industry.

How are QA and QC organized at your company? Share your experience in the comments.

#QualityAssurance #QualityControl #QualityUnit #Pharma #MedicalDevices #qualitymanagement

Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management.

Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

Learn more about Let’s Combinate:
https://www.letscombinate.com

Schedule an introductory call:
https://calendly.com/letscombinate/let-s-combinate-intro-session

Connect with Subhi on LinkedIn:
https://www.linkedin.com/in/subhi-saadeh-1169aa21

Listen to Let’s Combinate on Apple Podcasts:
https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792

Listen on Spotify:
https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2

Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of how regulated businesses actually operate.

In this video, Subhi Saadeh explains three reasons everyone in the industry should consider spending time in quality:

You learn how the business works. Quality follows the product across its lifecycle from development and suppliers through manufacturing, operations, regulatory changes, and post-market activities.
You develop judgment. Quality professionals regularly make structured, risk-based decisions in gray areas and document those decisions so they can withstand audits, inspections, and future review.
You learn to influence without owning everything. Quality is often accountable for outcomes without directly controlling every activity, which requires strong questions, clear communication, and the ability to help teams navigate competing priorities.

Even if you do not spend your entire career in quality, the experience can make you a stronger decision-maker, collaborator, and leader throughout the rest of your career.

00:00 Why Quality Matters
00:35 Why Work in Quality
01:41 Reason One: Learn How the Business Works
02:47 Reason Two: Make Defensible Decisions
05:23 Reason Three: Influence Without Authority
07:43 Key Takeaways

About Subhi

Subhi Saadeh is a consultant, trainer, auditor, and the founder and principal of Let’s Combinate. He has spent his career across medical devices and pharmaceuticals, with experience spanning research and development, industrialization, quality systems, and combination products. Through Let’s Combinate, he helps professionals and organizations better understand the intersection of drugs, devices, quality, and regulatory requirements.

Most discussions about One QMS focus on harmonization.

But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organizations structure a QMS.

In this episode, I compare centralized, decentralized, and federated (hybrid) Quality Management System models, including the trade-offs of each in terms of ownership, standardization, flexibility, governance, and decision-making.

We also walk through how the document hierarchy typically differs across each model—from the Quality Policy and Quality Manual to standards, SOPs, work instructions, and records—and discuss why governance often has a greater impact on success than the operating model itself.

Timestamps

00:00 Why "One QMS" Is Trending
01:33 The Three Primary QMS Models
01:50 Centralized QMS
02:01 Decentralized QMS
02:28 Federated (Hybrid) QMS
03:50 Comparing the Document Hierarchy
04:14 Centralized Document Structure
05:04 Decentralized Document Structure
05:22 Federated Standards, SOPs, and Governance
06:50 The QMS Tree: Philosophy, Governance, and Execution
08:20 Why Governance Matters More Than the Model

Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.