Validation entails using various reliable methods of testing to ensure that the object of the validation (process, product, device, facility, method, etc.) works in accordance with predefined criteria. Validation is a planned, tested, documented and approved demonstration that a process, method, facility, equipment, system, etc., operates smoothly and continuously.
· Preparing the user requirements specification (URS)
· Pre-mappings (e.g., preliminary measurements)
· VMP (Validation Master Plan) preparation and guidance
· Validation plans and reports
· Validation tests
· Validation training
· Project supervision (e.g., cleanroom implementation)
· Risk assessment
Most of the work we do is related to the validation of GMP cleanrooms and their equipment.
Why is validation needed?
Validation is part of quality assurance because the flawlessness and quality of a product cannot be proven by testing and analysing the final product alone. Rather, quality should be integrated into both the product and its manufacturing process. Validation is a way to demonstrate integral quality, as it is not possible to verify the quality of the product afterwards! Once a product has been made and an error has occurred, there are far fewer options available to alter the product to fit the needs, requirements and expectations of the customer.
It is also not possible to guarantee the high quality of an entire batch with quality control checks of individual samples. In addition to patient safety, profitability and cost efficiency are also important for businesses. Having to reject batches or recall products is very costly and can hurt the company’s reputation. Quality does always come with a price, but careful and accurate initial action is less expensive than being forced to repeat. Certain validation documents may also be required as part of the marketing authorisation application, and validations are one of the key areas of regulatory inspections as well.
When to validate?
The validation process should start well before production commences. The early stages of product development are preferable as specifications can be used in actual validation tests and the entire product development phase can be comprehensively documented. One of the common errors we see is to complete product development and transfer the responsibility of the product to production, only then to start planning for validation. This procedure creates enormous difficulties, for example in assessing acceptance criteria, and can delay the start of production. The actual validation phase is completed once the report is approved and the object of validation goes into official operation. After that, the object goes into maintenance mode, requiring regular checks of validity throughout the entire lifecycle.
Typical validation process for premises