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Process Validation through New Guideline

Process Validation through New Guideline

There are three stages of process validation through new guideline process design, process qualification, and continuous process verification. And four types of process validation are Prospective validation, Concurrent validation, Retrospective validation, and Re-validation.

Here what I will do is to correlate the types of process validation with these three stages of validation, as per the US FDA. So, before the start let me first tell you, what is process validation?

What is Process Validation?

Process validation is defined as the collection, and evaluation of data from the process design space throughout the production, which establishes scientific evidence that the process is capable of consistently delivering quality products.

Objectives of Process Validation

Process validation is a critical part of the quality assurance procedure. If I am talking about practically, for every sector nowadays, you have to perform process validation in various stages of the product lifecycle to confirm whether your process is effectively controlling the quality of your finished product or not.

Now let me tell you what the FDA thought process about Quality Assurance as principal. First, you can’t assure the quality by only doing in-process checks and performing testing in finished products.

Process should be designed in such a way so the quality safety, and efficacy are embedded into the product. To understand this theory there is another concept called quality by design. I covered that in the next article.

The question is how to correlate this process validation with product quality. Once you validate the process, it shows that your process is consistent enough to produce the quality product from batch to batch and unit to unit. I try to correlate how process validation is important to get a quality product.

Now we want the various systems of the PD, which I have told you in the beginning.There are three stages of process validation.

Stage1: process design.

Stage2: process qualification.

Stage3:  continuous process verification

And the four types of process validation are perspective validation, concurrent validation, retrospective validation, and revalidation. All the three stages are elaborated and correlated with the validation types below.

Stages of process validation

Stages of process validation flow chart
  1. Process design

At this stage, we define the commercial production process which is suitable for commercial manufacture. At this stage, we take the various pilot and spill of batches to identify which quality attributes in which process parameter are critical, that means we define the CQAs and CPPs.

That is critical quality attributes and critical process parameter, which to be monitored in Phase two. We do the risk assessment and define what controls we put to mitigate the risk for that we use some tools like FMEA that is Failure mode and effects analysis.

I correlate the phase one with prospective validation. If you see this type of validation is performed before the production, and during the development stage. So, we define the process parameter, in a situational base of the knowledge gain of the process validation, and throughout the trial plan and do the risk analysis and established the control strategy that’s why it is called prospective validation.

So, both stage one in the that is process design and prospective validation is very similar in the field in terms of work we perform. Now move on to stage2 process Qualification.

  1. Process Qualification

Correlate this stage with another type of validation that is concurrent validation and this is nothing, but we Qualified the process in which we have a design in stage1. In the general term, we called this is a process validation for this we qualify our process with three commercial-scale production batches and monitor all the process parameter as closely as possible

.We do the stratified sampling and collect all that data for CQAs and CPPs which is called critical quality attributes and critical quality process parameter. which gives us in-depth insight on variability and our current controls.

We also check the design of a facility in qualification of equipment at this stage, the goal of this stage is to assure and demonstrate that the process will remain in the state of control during the commercial manufacturing process.

If you read about the concurrent validation, we do the same thing that I have explained here for stage2 which is process qualification.

Now move on to stage3 continuous process verification.

  1. Continuous process Verification

At this stage, we can correlate with this stage with the retrospective validation so at this stage we collect and evaluate the information and data about the performance of the process and final control test.

We try to determine how well the process parameter remains to the acceptable range by doing such evolution, we assume that the process composition and equipment remain unchanged and data should be check periodically to determine whether requalification would be performed or not.

this analysis includes relevant process trends, quality of incoming material, in-process material, etc. And the data generated is statistically trended and reviewed by the trained personnel or subject master experts so this is all about continuous process verification or retrospective validation.

  1. Revalidation

Now the last one is the revalidation. Before telling you about the revalidation, Just let me ask the question and answer you why revalidation is required. So, whenever you have introduced a new element in the manufacturing process, the revalidation has to be performed to find out the effect of this change.

So, when any change is made into the process or its environment it is essential to ensure that it should not have any adverse impact on the product quality or process characteristics.

So, there can be several changes in the manufacturing process on any standard operating procedure that may affect the product quality. So, I will give you a few examples here for why a revalidation is required.

Process revalidation examples

Changes in starting materials

If you change the source of material there is the chance to change in physical attributes which can alter the mechanical properties of the material and consequently, we have an adverse impact or effect on the product or the process.

Changes in packing material

If you switch the packing material, you may also undergo to make the changes in the product procedure you have following during the packaging. So, which may impact product quality or product stability.

Changes in process

Anytime if you alter the manufacturing process may be chances that the subsequent step may be affected because the change you have made the change in a process in which may affect the product quality.

Changes in equipment

Many times, it is required to repair maintenance and replacement of any key component of the equipment Fault. So, it is mandatory to assess whether the quality is affected after any change is repair or replacement or any maintenance activity is performed.

Changes in a support system or production area

Sometimes there are rearrangements in the support system or production area which may also affect the product quality especially if you are making any change like the ventilation system HVAC system.

So, it is all about the validation, Thanks for reading this post. I have explained to you here referred from the FDA’s guidance. SOP for Process validation

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