Process Validation

Validation of the manufacturing process is the ultimate goal of any validation policy

The fundamental GMP requirement for demonstrating adequate process control and the ability to manufacture reproducible product with the established quality.

Product Lifecycle

The concept of validation has evolved significantly over the past 20 years.

Process validation should be understood, beyond the traditional ‘three consecutive batches’, as the documented evidence of a solid scientific knowledge and understanding of the process, considering the critical parameters of the process and how these affect the quality attributes, the risks on the product and the process and the control mechanisms established for their prevention throughout their Lifecycle.

Three Stages of the Product Lifecycle

1. Products and Process Development

2. Validation of the Manufacturing Process

3. Keeping the Process in a Controlled State

Quality by Design (QbD) Approach

Product Lifecycle

Products developed under a Quality by Design (QbD) approach, where the control strategy for the process can be scientifically and comprehensively defined, continuous manufacturing can be used and and then, continuous process verification can replace the traditional validation approach.

Ongoing Process Verification

From the FDA’s ‘Risk-based approach’ initiative in 2002 to the present day and with the entry into force of new FDA guidelines (2011), EMA (2014) and the update of EU GMP Annex 15, there have been significant changes in the validation of manufacturing processes. 

In fact, the “three-stages” approach, highlighting the incorporation of the ongoing process verification (EU) or continued process verification (FDA) stage and the relevance given to the statistical processing of process and product data, are dramatically changing methodologies and approaches to address this essential requirement of GMP.

The main objective becomes to continuously ensure that the process remains in an adequate state of control during commercial batch manufacturing, as well as to facilitate the identification of necessary changes in the control strategy to drive continuous product and process improvement. 

To this end, a program for the collection and analysis of process and product data and their continuous quality must be established.

Ongoing Process Verification

Implementation should be an activity integrated into the company’s quality system and facilitates the identification of areas for improvement

Rephine has extensive experience at the international level in Process Validation, supported by numerous projects and successful inspections of our customers by the European health authorities and the FDA (Pre-Approval/Regular Inspections), including among others:

  • Validation of manufacturing and packaging processes
  • Ongoing process verification
  • Validation of cleaning methods
  • Validation of sterilization processes

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