Process Validation

Line of Sight Process Validation

An evolution, if not a revolution, is underway.  Industry and regulatory risk and science based expectations have changed Drug, Biologics and Medical Device validation.  The 2011 FDA Guidance for Industry on Process Validation: General Principles and Practices, and subsequent revisions to EU Annex 15, USP <1116>, ISO 14644 and other industry guidance and standards mark represent the need for true critical thinking and pragmatism in Validation approach.

Guidance to the industry specifies a risk-based thinking model to establish, prove and maintain process control. Replicate runs and batches have proven insufficient. Process validation conducted as a sustained and consistent activity gleans valuable information at every stage of the process lifecycle.

The Approach

Properly planned validation process is essential to execution of compliant and eff­ective manufacturing process validation. ValSource Line of Sight approach will help you understand the basis of design for the process and its relationship to product quality and output.

Line of Sight views the process lifecycle from beginning to end, leveraging the knowledge gained at each stage along the way.   Developed by ValSource, Line of Sight process control enables design, planning and implementation of essential risk-based approaches. Line of Sight’s unassailable scientific principles generate practical, efficient procedures to evaluate and solve complex manufacturing problems. Using the Line of Sight approach, ValSource provides full lifecycle process validation, from process design through control strategy development, qualification, and continued/ongoing process verification.   The lifecycle approach ties all aspects of start-up of a facility, line, and process together. Proprietary software collects and manages information throughout the design and construction effort.

ValSource’s S3 method ensures “right-sized” testing, sampling and batch quantity, combining Science, Statistics and Strategy to apply risk, knowledge management and best practices to the process validation lifecycle. This is an optimal method for determining and defending sample and batch requirements for PPQ and CPV stages of PV.  The approach uses ValSource’s C2 method for determining optimal sampling plans. C2 is a simple, yet powerful statistics technique using principles of Confidence and Coverage for answering the most commonly asked questions: How many batches? How many samples? C2 uses product knowledge and relative risk to determine the number of samples or coverage needed.

The Pains.

Complicated and costly sampling plans

Time consuming Validation batches

Sub-optimal processes and burdensome testing requirements

Resource draining failures, investigations, deviations, and citations

Unsustainable continued process verification programs

The Relief.

Streamline and meaningful testing programs linked directly to critical quality attributes

Logical prioritization of efforts based on risk and science

Processes that work right the first time

Reduction in failures and defects

Continuous improvement through knowledge and process understanding