4 Types of Process Validation in Relation to Production

Process validation is a critical part of quality assurance procedures, for practically any sector or industry today. You can perform process validation at various stages of the production lifecycle to confirm whether your process is effectively controlling the quality of your finished product.

Based on the stage of the production lifecycle at which process validation is performed, it can be of four types:

1 Prospective Validation

This type of validation is performed before production, during a product’s development stage. A risk analysis is performed to assess the production process by breaking it down into separate steps. These are individually evaluated and based on past experience, the likelihood of each one leading to critical situations is determined.

Once you’ve identified the critical sub-processes, these are the steps you should follow:

  • Evaluate individual risk for each one
  • Investigate and assess
    • Potential causes
    • Probability of situations arising
    • The extent of their effects
  • Draw up the trial plans
  • Set priorities for the validation

After this, you can begin with the trials and make an over assessment. Prospective validation is essential for limiting the risk of quality lapses and errors occurring during the actual production.

2 Concurrent Validation

You should monitor the first three batches produced on a production-scale as closely as possible. The data gathered through this step can provide an in-depth insight of the fundamentals, which greatly impacts the effectiveness of concurrent validation.

Together with comprehensive trend analysis, which includes other aspects like stability, you should perform concurrent validation throughout a product’s life to whatever extent it is needed.

3 Retrospective Validation

As the name suggests, retrospective validation is rather like validation in hindsight. It involves examining the past experiences of the process and evaluating the final control tests. This evaluation is done while assuming that the procedures, composition and equipment remains unchanged. To determine how well the process parameters adhere to the permissible range, you can also conduct a trend analysis.

Retrospective validation should not be considered a quality assurance measure, rather it should be performed only in certain circumstances, like when you’re introducing validation requirements for the first time. It is more useful for establishing priorities for validation, so avoid this technique for new products or processes.

4 Revalidation

Revalidation is essential for ensuring that any changes made to the process or its environment have not resulted in adverse effects on product quality or process characteristics. It can be divided into two sub-types:

  • Revalidation after Changes – Whenever you’ve introduced any new elements in the manufacturing process, revalidation needs to be performed to ascertain their effects. There can be a number of changes in the manufacturing or standard operating procedures that impact product quality. These can be:
    • Changes in Starting Materials – Changes in physical attributes can alter the mechanical properties of compounds and materials, which can consequently have adverse effects on the product or the process.
    • Changes in Packaging Material – If you switch packaging materials, you may also be forced to make changes to the procedures followed during packaging, which can impact product stability.
    • Changes in Process – Any time you alter the manufacturing process, the subsequent steps can be affected and thereby, the product quality too.
    • Changes in Equipment – Repairs, maintenance and replacement of key components is unavoidable, but be sure to assess whether quality is affected and how much.
    • Changes in Support System or Production Area – Rearrangement of support systems or production areas can also affect product quality, especially critical systems like ventilation.
  • Periodic RevalidationSimilar to regular maintenance, calibration and other core requirements, revalidation at scheduled intervals helps you ensure that your systems and checks are performing within the required standards.
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