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Process validation refers to the process of collecting and evaluating data, from the process design stage throughout production process, establishing scientific evidence that a process is capable of consistently delivering quality products. It is a series of activities occurring over the lifecycle of the product and process.

The US Food & Drugs Administration (FDA) defines process validation as established documented evidence that provides a high level of assurance that a process consistently produces a product that meets its predetermined specifications and quality attributes.

Process validation activities can be achieved in the three stages as follows:

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  • Process Design

This is the first stage of process design that involves defining the process for manufacturing the product. It is the research and development phase of validation. In this stage, the commercial process is defined based on knowledge gained through development and scale-up activities. This stage involves data gathering which can be used to optimise production processes, create efficiencies, and troubleshoot problems. 

Among the activities of this stage includes determining process parameters, conducting risk assessment, determining critical quality attributes and targets etc.

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  • Process Qualification

At this stage, the process design is evaluated to confirm that it is capable of reproducible commercial manufacturing. It involves evaluating the already designed process to ensure that it can reproduce consistent and reliable levels of quality, through collection and evaluation of data on all aspects and stages of the manufacturing process. Contingency plans can also be developed at this stage for situations where things don’t go as planned. 

Examples of activities undertaken at this stage includes ensuring that the facilities adhere to local and manufacturing regulations, storage of raw materials, training of production line employees, storage of raw materials, packaging, storage, and distribution of finished products etc.

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  • Continued Process Verification

This is an ongoing assurance through evaluation during routine the manufacturing process that the process remains in a state of control and continues to deliver consistent quality. At this stage, inconsistency or process deviation are detected and resolved. At this point, product sampling, analysis, and verification at strategic points in the manufacturing process are conducted. 

The three stages of process validation require the involvement of adequately trained quality control employees in addition to comprehensive record-keeping, including logging anomalies and issues with product quality.

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Types of process validation

There are basically four (4) types of process validation namely, prospective validation (or premarket validation), retrospective validation, concurrent validation & revalidation.

  • Prospective validation 

This type of validation (also called premarket validation) involves establishing documented evidence before process implementation that a system does what it proposed to do based on pre-planned procedure. This type of validation is usually undertaken during new product development (or within a new facility) which requires that such a system be validated before routine production commences. This approach usually results to transfer of the manufacturing process from the development to production.

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  • Retrospective validation

This type of validation applies to facilities, processes, and process controls in operation that have not undergone a formally documented validation process. This is possible using historical data to provide the necessary documentary evidence that the process is operating as intended, and is only acceptable for well-established processes. Where there have been recent changes in the composition of product, operating processes, or equipment this type of validation would be inappropriate. Retrospective validation is used only for the audit of a validated process.

  • Concurrent validation

This is used for establishing documented evidence that a facility and processes performs as it promises, based on information generated during actual operation. This approach involves monitoring critical steps of the manufacturing process and end product testing of current production, in order to establish that the manufacturing process is in a state of control.

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  • Revalidation

Revalidation refers to the process of repeating the original validation effort or any part of it including investigative review of existing process or performance data. This type of revalidation is essential to maintain the validated status of the facility, equipment, process steps and systems. The extent of revalidation procedures depends on the extent of the changes and their effect upon the product. 

Revalidation process may be initiated due to: transfer of a product from one plant to another, changes to the product, the plant, the manufacturing process and/or others that could affect product quality, sequential batches fail to meet product and process specifications, significant increase or decrease in batch size etc.

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About the Author

Olanrewaju, Adebayo Bamidele is a Lead Auditor of ISO 9001, FSSC 22000 / ISO 22000, 14001 & 45001 Management Systems, Certified Six Sigma Master Black Belt (CSSMBB), process engineer, and quality management professional with strong working experience and proven skills in manufacturing excellence, ISO management systems implementation, lean / digital manufacturing, and project management. 

Adebayo is a Corporate Member of American Institute of Chemical Engineers (AIChE), Associate Member, the Institution of Chemical Engineers (IChemE), Corporate Member, Nigerian Society of Engineers (NSE), Corporate Member, Nigerian Society of Chemical Engineers (NSChE), Associate Member, Nigerian Institute of Management (NIM), and Associate Member, Institute of Strategic Management of Nigeria (ISMN).

He is an author of over 15 books and has published over 45 online courses on various e-learning platforms including UdemyAlison, Learnformula & Study Plex.

You can reach him, here.

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