PROCESS VALIDATION (PV)

PROCESS VALIDATION (PV)

According to FDA, PV is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products

Process Validation program is used when creating a process for producing a pharmaceutical product. From the definition it implies that the process should be able to produce a pharmaceutical product consistently and reliably.

To ensure consistency, there is need for continuous collection and evaluation of data, thus process validation is a continuous cycle and a never ending process

Whilst PV is aimed at commercial production of a product, the process must start when developing a product, as the results from this stage will also impact the PV program

PV consist of 3 Stages which are:

Stage 1: Process Design

Stage 2: Process Qualification

Stage 3: Continued Process Verification

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In this article we will discuss more on stage 1 of the PV program which is Process Design/Process Development

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STAGE 1: PROCESS DESIGN

This stage focuses on defining commercial manufacturing process that is capable of manufacturing a pharmaceutical product consistently and reliably

This stage consist of planned master production and various documents such as Standard Operating Procedures (SOPs) and Protocols.

In order to complete the process, one needs to have product knowledge, process knowledge and an understanding of equipment being used.

One important aspect in process development is Process Control/Change control

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Process Control

These process control strategies are aimed at minimizing variation and adjustments in the event of a variation occurring

Every change in the process, even small change must go through a formal change control program. Some common changes include, change in raw material suppliers, changing a blender, changing storage location or changes in SOPs

This process also involves identifying Critical Process Parameters (CPP) as well as Critical Quality Attributes (CQA) of the product

Process control involves examination of raw material quality, monitoring equipment and operating conditions so that it’s in adherence with the set CPP.

It is mostly important to have written records of all the changes which may occur in the process as this will help compliance with the Regulatory Authorities.

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One of the most important documents in Process Design is the Validation Master Plan (VMP) which we will discuss in greater detail in next article