As times change so do the expectations of the regulators. This holds true with validation as well. More global health authorities and regulators are communicating their expectations for risk and science based justification for process control and validation approaches. Let’s take a quick look at how the definition of Process Validation has evolved:
Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.
- ‘87 FDA Process Validation Guidance
Defined process validations 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.
- ‘11 revision to FDA Process Validation Guidance
Notice that these two statements are vastly different. So are the expectations.
A lifecycle approach to validation follows the product and the process throughout its life. Let’s see what the EMEA has to say about validation:
Process validation should not be viewed as a one-off event. … incorporates a lifecycle approach linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production.
- EMA process validation submission guidance
It appears as through the expectation from the regulating bodies is that validation is no longer an event that is performed once, but rather a continuous process of monitoring and evaluation. This constant monitoring is referred to as Process Verification.
Ongoing Process Verification…….
5.29. Manufacturers should monitor product quality to ensure that a state of control is maintained throughout the product lifecycle with the relevant process trends evaluated.
5.30. The extent and frequency of ongoing process verification should be reviewed periodically. At any point throughout the product lifecycle, it may be appropriate to modify the requirements taking into account the current level of process understanding and process performance.
5.32. Ongoing process verification should be used throughout the product lifecycle to support the validated status of the product as documented in the Product Quality Review. Incremental changes over time should also be considered and the need for any additional actions, e.g. enhanced sampling, should be assessed.
- Annex 15
In closing; good process design, robust process qualification and ongoing process verification are necessary for future success. Principles of a lifecycle approach should be used to improve current processes. One cannot predict every failure; thus the need to continuously monitor the process and react accordingly should be a way of life.
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