Manufacturing of drug products in pharmaceutical industries is a very critical process and the main goal of any manufacturing process is to ensure the production of good quality products for patient compliance and safe use.
Quality by design concept is used to ensure that each step carried out during the manufacturing process will contribute effectively for the required product quality.
To ensure good product quality the identification of CQAs and their compliance is very important.
What Is CQA?
CQA is a critical quality attribute and is defined in ICH Q8 R2 as
Chemical, physical, biological or microbiological characteristics or properties of a drug product, which must be controlled within a defined limit or range to ensure product quality.
How To Identify CQA
Critical quality attributes are defined based on the patient’s safety or harm to the patient. At the initial stage, all the quality attributes of the drug products are selected and their impact on patient safety is assessed e.g
the colour and shape of the drug products have no harm to patients so it will not be the CQA.
On the other hand product assay or dissolution profile has a severe impact on patient safety so it will be the CQA.
Split the manufacturing process into different steps and identify the critical quality attributes for each step.
After identification of top-level CQAs, define CPPs (critical process parameters) and perform process validation. If required results (CQA) are achieved in validation then define CPPs
in the batch manufacturing record as CPPs are the input and CQA is the output.
Explanation
Critical quality attributes of a product are those properties which can not be checked before or during the inprocess. These are checked by analysis or testing at the end of a specific activity.
So we critically monitor the critical process parameters related to the specific CQA to
to get the required product quality attribute.
Examples
If we take the example of tablet manufacturing then there are different steps involved in the tablet manufacturing and we will identify the different quality attributes for each step.
Suppose we take the example of the final blending step then the following will be the CQA
- Assay
- Blend uniformity
- Tap density
- Bulk density
To ensure the required CQAs we will critically monitor the CPPs which may be the following,
- Blender RPM
- Blender load
- Blending Time
We can’t check the assay of the product without analysis after completion of the blending process but if we critically follow the process parameters and keep them in range meaning we run our blender at defined rpm with defined load for a defined period of time then our assay will be within range.
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