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

Related Resources

CE Mark MDSW Case Study Header Case Study

2023 Medical Devices CE Mark for a MDSW (Medical Device Software)

About this Case Study The case study involved CE Mark for a new Medical Device Software. The company has developed software that is considered as …

Read More
We're Exhibiting! India TUG (2000 × 1044px) (1) Article

Rephine Exhibit at India TrackWise User Group Mumbai – Sept 1st

Rephine to Exhibit at the Upcoming India TrackWise User Group in Mumbai on September 1st We’re thrilled to announce that the Rephine India team will …

Read More

Rephine Golden Ticket

With Rephine everyone’s a winner! Thank you for visiting us! Submit the form and take advantage of some sweet offers: 15% off library report*Or10% off …

Read More
TW China PR blog header Article

Rephine agrees Chinese distribution partnership with Trackwise

Rephine’s Chinese division signs to provide Implementation and Validation services for TrackWise EQMS solutions.   Stevenage, Hertfordshire, 4 August, 2023 – Rephine, the experts in …

Read More
Mock Inspection USA Case Study Header Case Study

2023 Mock Inspection USA Market

About this Case Study The case study involved a pharmaceutical company seeking to bring a product, manufactured in Europe, into the US market for commercialisation. …

Read More
Medical Devices service image.png Case Study

2023 Medical Devices Mock Inspection

About this Case Study The case study involved verifying GMP compliance in an IVD company to enable the commercialisation of their products in the USA. …

Read More
GG PR blog header (5) Article

Rephine and Greenlight Guru Partner to Enable QMS for the Medical Device Sector

Rephine now offering QMS services to medical device companies through new partnership. Stevenage, Hertfordshire, 28 July, 2023 – Rephine, the experts in quality assurance & …

Read More
IVD Tech file update Case Study Header Case Study

2023 In-Vitro Diagnostics Products Technical File Update

About this Case Study The case study involved updating the Technical File documentation for more than100 IVD products according to Regulation (EU) 2017/746. The company …

Read More
Rephine Symposium Blue Back General

Rephine Virtual Symposium 2023 Video Recordings

About these recordings Missed out on the insightful sessions and captivating discussions from our esteemed speakers at the Rephine Symposium? Don’t worry, we’ve got you …

Read More

Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.
Social: Linkedin



  • Barcelona, Spain                               
  • +34 934 178065


  • Shanghai, China 


  • Hyderabad, India