Validating to be processes

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For FDA approval, the process validation will need to be rationalized and accompanied by appropriate documentation.

To determine if a process requires validation or verification, many factors need to considered carefully.

Verification plays a role in almost every stage, from initial development to production and upscaling.

Validation comes into play later in the manufacturing lifecycle once the product is verified and can be tested.

Process Validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard.

Regulatory authorities like EMA and FDA have published guidelines relating to process validation.

The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria.

Gretchen Allison, senior director and team leader for Global Quality Validation, Pfizer Global Supply, spoke with Allison (Pfizer): Key considerations for validating a continuous manufacturing process rely on many of the established principles of basic pharmaceutical process development, guides, and standards that the pharmaceutical industry generally applies to validating traditional batch processes—for example, the establishment of critical quality attributes (CQAs), critical process parameters (CPPs), and corresponding acceptance criteria for a given product and process.

Designing and running accelerated endurance tests with carefully selected parameters (moderately exceeding the norm to make up for the reduced time) can help you determine which of the proposed solutions creates a better-performing, longer-lasting part.

Will the proposed change improve or worsen availability and functionality?

To try to clear things up, let’s look at a simple example of a gear cog that has been manufactured as per the requirements stated by a client: Now that’s just a simple gear cog, but when it comes to building more complex machinery, the likelihood of unforeseen hurdles increases exponentially.

Both verification and validation play critical roles in quality management, reducing errors and making sure the product conforms to the user’s requirements, industry standards and regulatory authority guidelines.

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