Process and Equipment ValidationEffective process validation is an essential part of product manufacture.
Documenting process design, installation, challenge/optimisation and process performance.
Establishing objective ,scientific evidence, that a process is capable of consistently producing quality products.
Often regarded by manufacturers as ‘non value added’ rather than an effective Project Management tool, ‘Validation’ is often not fully implemented.
Within medical device and pharmaceutical manufacture it is a regulatory requirement. The consequences of ineffective validation can be audit findings from a Notified Body (FDA, ISO) or Inspection Observations.
Validation is, however, a cost-effective project management tool, ensuring the development or improvement of processes which deliver consistent, conforming product. The ongoing costs associated with consistent non-conformance are likely to far exceed those associated with effective validation.
Some studies estimate the ‘cost of poor quality’ within life sciences to be as much as 25—35% of sales revenue. Driving down operational costs to maintain margin can be best served by ensuring your manufacturing processes produce products which consistently conform to specification.
Effective validation of your new or existing process, ensuring good process capability against predetermined specifications can ensure consistent conformance and increased Overall Equipment Effectiveness (OEE).
Contact us now to discuss how we can help to Validate your new or existing processes, equipment or plant services.
Definition 21 CFR 820.3 - ‘Process Validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.’