Simple way to understanding of CQA-Critical Quality Attributes and CPP-Critical Process Parameters

As a Biopharma professional understanding of any process of drug manufacturing is very important. furthermore, important is to Product quality and Patient safety.

With aim of to provide consistent quality of drug, any industry run their business. "Product Quality" is top tagline but how we can achieve it?

Product quality can achieve by designing the quality. What? 

Yes First step is QbD(Quality by Design).

What is QbD?

QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.(ICH Q8 R2).

Let's Understand the definition:

First of all Firm should have pre-defined objective means what type of product quality is required.

The second thing we should have understanding of Product and Process.

The third thing we should have a sound scientific rationale.  

Once we have above mentioned three things, then we can do the quality risk management and get the controlled process.

This whole blended systematic approach is known as "Quality By Design." (Demonstrated in Below image)

 

Systematic approach of QbD

Now, in Pharmaceutical terms,

What type of product quality is required? Means Firm should have QTPP (Quality Target Product Profile).

What is QTPP?

A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy.(ICH Q8 (R2)

It means Firm should have target parameters which are required to achieve desired quality in product.

And these parameters are known as "Critical Quality Attributes" (CQA).

What is CQA?

A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality (ICH Q8).

It's mean that CQA is final output, which is define the product quality but who is controlling the CQA?

Very Simple...

Results are controlled by the efforts taken during the preparation.

Same way CQAs are controlled by CPPs (Critical Process Parameters).

What is CPP?

A process parameter whose variability has an impact on a CQA and therefore should be monitored or controlled to ensure the process produces the desired quality.(ICH Q8).

It means that variability of CPP can impact the CQA.

One Step Ahead to CPP is CMA (Critical Materials Attribute).

What is CMA?

A physical, chemical, biological or microbiological property or characteristic of an input material that should be within an appropriate limit, range, or distribution to ensure the desired quality of output material.(CMA is not defined in ICH guidance, but used here for understanding)

I think now it is clear that what is CQA, CPP and CMA. You can also share your thoughts on this.

Note: Opinion expressed in this article is my view of understanding, however reference of guidelines are taken wherever required. 

Abbreviations:

ICH : The International council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

QbD : Quality By Design.

CQA : Critical Quality Attributes

CPP : Critical Process Parameters

CMA : Critical Material Attributes