the 7 guides to unlock a successful risk based cqv project no deviation

The 7 guides to unlock a successful risk-based CQV project

Our previous post talked about the skills a CQV engineer needs. In this article, we will give you the CQV starter kit with 7 documents that will guide you in unlocking a successful risk-based CQV project. It has everything you need to understand the journey of equipment into the different phases of the project, and why you need to read them.

We will lay down those 7 guidances, not in the chronological order they were published, but in the order you should read them, allowing you to gain the knowledge to go to the next step in your career or project.

The first 3 pillars of the CQV engineer

1. Guidance for Industry – Process Validation: General Principles and Practices – 2011

Published in 2011, this FDA guidance was the outcome of a working group led by Dr Janet Woodcock, working on the pharmaceutical quality for the 21st century.

Reading this guide, you will learn about the 3 stages of the product life cycle:

1 – Process Design

2 – Process Qualification

3 – Continued Process Validation.

Phase 2 is the core business of CQV engineers.

Best quote: Quality cannot be adequately assured merely by in-process and finished-product inspection or testing.


If you are not yet familiar with risk management and, more particularly, the risk that could affect patient safety, this document is a must. Some people find it outdated, too simple, yet it will set the foundation. Quality Risk Management will allow you to understand how we can reduce the risk for the patient. In this document, the risk is defined as the probability of something happening and the severity of harm if it happens. Our job is to focus on reducing the occurrence of the risk.

Best quote: The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk.

3. ASTM-E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment – 2007

An iconic document in the CQV world of generation X I’m from! Initially published in 2007 (the year No deviation was incorporated…would this be a sign?), this document is LE MUST read if you ever get to an interview for a CQV job. Jokes aside, this USD$64, 5-page document will be money well spent. It spells out the use of a risk-based approach (ICHQ9) for Equipment Qualification (phase 2a of the process validation). It was, for long, the only document that defined the critical aspects of a system.

Best quote: “Vendor documentation, including test documents, may be used as part of the verification documentation, providing the regulated company has assessed the vendor…”

If you went to download those 3 documents, take a break. You have opened the door to the wisdom of the CQV world. If you already know these 3 documents, let’s keep going.


In line with the FDA initiative for pharmaceutical quality for the 21st century, the ICH Q8’s primary objectives were to design a quality product and its manufacturing process to consistently deliver the product’s intended performance. This 28-page long document might be more suited if you are a chemical engineer rather than a mechanical one. Don’t sweat if you don’t get everything the first time. You will still learn some significant process elements. You will now understand terms like the Quality Target Product Profile (QTTP) and how it is linked to the Critical Quality Attribute (CQA) and Critical Process Parameters (CPP).

Understanding CQA and CPP will be the key to unlocking the risk-based approach delivery of your CQ project.

Best quote: It is important to recognise that quality cannot be tested into products; i.e., quality should be built in by design.

5. Annex 15: Qualification and Validation – first draft – 2001 / latest draft 2015

Annex 15 describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products. The document is the only regulatory one I know that defines protocols such as URS/DQ/FAT/SAT/IQ/OQ/PQ. Yes, you read this right – none of the above guides detail the protocols to use, while Annex 15 does it. So only for that, it is a good read.

When reading this document, the first question you should ask yourself is, what is it annexed to? We often talk about Annex 1 or Annex 15, but we forget the core document they are annexed to. The second question that should strike you is, what other annex is there? This would be too easy if I told you, and you will remember it better if you Google it.

Best quote: The key elements of the site qualification and validation programme should be clearly defined and documented in a Validation Master Plan (VMP) or equivalent document.


ICHQ10 – 16 pages of packed information and principle of your pharmaceutical quality system, well beyond the scope of C&Q. BUT, don’t skip it yet. What’s most important when doing commissioning and qualification is not the activity itself but how it will contribute to patient safety. C&Q is the equivalent of laying bricks when building a cathedral. Keep the end in mind and develop empathy for the patient you contribute to, for keeping safe!

Best quote: Implementation of the Q10 model should result in the achievement of three main objectives which complement or enhance regional GMP requirements. 1. Achieve Product Realisation, 2. Establish and Maintain a State of Control, 3. Facilitate Continual Improvement

7. Now you are ready for the Bible of the C&Q, THE Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition – 2019

This follows the original edition of 2001! Eighteen years in the making. This guidance will walk you through the practical application of the risk-based approach to delivering C&Q projects. The guideline defines the term Critical Design Element, those system functions and features identified as having the potential to control risks to product quality and therefore ensure patient safety, the one you need to qualify.

To focus on what matters in the qualification phase of your project, you will learn how to perform system classification and system risk assessment.

Best quote: The inputs to the integrated C&Q process include product and process CQAs/CPPs (NDLR ICH Q8) (established through research and development and/or the technology transfer process) and the application of QRM (NDLR ICH Q9) to define the control strategy (NDLR ICH Q10)

Now that you are ready to roll, review your CV, your CQ plan, what you did last year or what you will do tomorrow! Keep those references handy as they guide you in your everyday move and decision if you are working in the CQV field. But keep in mind that compliance is nothing if you don’t have quality, and that you can’t test quality; you need to build it first.

Personal note

Although every guidance mentioned here talks about commissioning and good engineering practices, none of the above actively defines those activities. There are other documents, both from ISPE and other organisations, that help with it. Keep in mind that you can’t qualify a system that is not working. You will need to rely on the Vendors / Subject Matter Expert and work with them to achieve qualification, validation, and finally, your control state.

If you need help with any of those concepts, or if you want to change your current practice to align with the latest industry best practices, No deviation has a range of experts that can help.

We can help you to define a project plan or implement it so that your facility equipment and utilities will be in a state of control. We do this effectively and efficiently. We tailor a program with training, coaching, and auditing. There is no secret in what we do, just a lot of experience.

Reach out to us if you are interested in knowing more about risk-based CQV. You can also visit our website for more information about No deviation and its services.