Critical Quality Attributes for Drug Products

This article is the fourth part of our “Best Practices in the CDMO Selection Process” series and explores the importance of Critical Quality Attributes (CQAs).

Blog
Published on:
September 14, 2022

In this article, we will explore the importance of Critical Quality Attributes (CQAs) in the drug development lifecycle and why it is vital that your selected CDMO is capable of addressing them.

The right CDMO should be able to assist you in addressing identified CQAs from an analytical perspective throughout the process development and manufacture.
What are CQAs?

CQAs represent the benchmark for most quality-by-design implementations. CQAs are part of the systematic development approach that begins with predefined objectives and emphasizes product and process understanding and process control. These are based on sound science and quality risk management (ICH Q8 R2).

CQAs are created with patients in mind and tied to the Quality Target Product Profile (QTPP). The QTPP includes all product quality characteristics and specifically, those critical to safety and efficacy as defined in the product label (Target Product Profile).

Quality targets serve as the basis for process development and guide the selection of process steps, material attributes, equipment design and operation controls for the manufacturing process.

How do you identify CQAs?

A CQA is a physical, chemical, biological, or microbiological property or characteristic that should be controlled within an appropriate limit, range or distribution to ensure product quality (ICH Q8 R2). ICH 6A further defines CQA specifications as the criteria that a drug substance or drug product must meet to be considered acceptable for its intended use. This includes attributes like identity, strength, purity and potency.

The approach to identifying CQAs begins with identifying all quality attributes and creating the QTPP. The QTPP can be considered an expansion of the higher-level TPP.

For example, the TPP defines the dosage form as IV, whereas the QTPP includes concentration, color and clarity. Next, all the quality attributes are evaluated for severity of harm (safety and efficacy) to a patient.

Not all quality attributes result in harm to a patient and so aren’t considered critical. For example, the size or shape of a drug, while important to commercialization and marketing, is not critical to safety or efficacy. However, impurities/degradants from an injectable product can lead to adverse events (AE) and negative patient consequences.

It’s important to note that identification of a potential CQA does not consider risk controls or risk management. For example, impurities are CQA, regardless of whether testing determines the risk of impurities to be low.

Using CQAs to inform development

Once CQAs are identified, the systematic approach (e.g., a risk assessment) should continue to process development; understanding the impact of critical material attributes and critical process parameters to the CQAs.

A risk-based approach (ICHQ9) over the development lifecycle identifies CQAs and informs an appropriate control strategy for drug substances and drug products. The CQA control strategy and justification should be described in the appropriate sections of the regulatory dossier, 3.2.P.3.3 Description and Manufacturing Process and Process Controls; 3.2.P.3.4 Control of Critical Steps and Intermediates; and 3.2.P.5.4 Control of Drug Product.

The right CDMO should be able to assist you in addressing identified CQAs from an analytical perspective throughout the process development and manufacture.

More on CDMO Selection Best Practices.

If you have decided to outsource your manufacturing and would like to identify the best CDMO for your project, we are here to assist. Our expert team has been helping companies choose the right CDMO for more than a decade – reach out to us to learn how we can support.

Related news

Blog May 24, 2023
Planning: Why It’s Worth the Time for Biotech Companies
Biotech expert Joris Pezzini covers the fundamentals of planning, one of the three required jobs for biotech leaders to be successful.
Biotech
News May 22, 2023
Alira Health Joins France Biotech as an Expert Partner
We are pleased to announce that Alira Health has joined France Biotech, an independent association that brings together healthcare innovation entrepreneurs and their expert partners.
Biotech Clinical Trials France Patient Engagement
Events May 15, 2023
BIO International Convention
We are excited to share that we will be attending the BIO International Convention in Boston. This leading industry event attracts biotechnology and pharma leaders for one week of intensive(...)
Biotech Pharma
News May 2, 2023
Alira Health Announces the Spin-Off of Product Development Laboratory
Alira Health, a global healthcare advisory, clinical research and technology company, announces the spin-off of ProDevLabs, a new company led by Dr. Mitchell Sanders, PhD, a former(...)
Drug Development Life Sciences Product Development
Blog April 27, 2023
The Biotech Industry Today: What Leaders Need to Know
Biotech companies today face a complex and often difficult funding, regulatory, and market access environment.
Biotech
Multimedia March 24, 2023
Webinar Replay: MedTech CDMO: Market and M&A Trends in the U.S. in 2023
Watch this webinar hosted by MassMEDIC to discover the current trends shaping the US medical device outsourcing landscape, with a particular focus on its performance and business outlook,(...)
CDMO MedTech
Blog March 20, 2023
The State of Market Access in Italy 2023
To learn about the state of market access in Italy today, we spoke with Giovanni Firenze, Director of Market Access Italy for Alira Health, who attended the recent 2023 Conferenza Nazionale(...)
Drug Development Italy Market Access Pharma
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.