Menu
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.
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.
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.
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:
Case Study 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 …
Article 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 …
Event 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 …
Article Rephine’s Chinese division signs to provide Implementation and Validation services for TrackWise EQMS solutions. Stevenage, Hertfordshire, 4 August, 2023 – Rephine, the experts in …
Case Study 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. …
Case Study 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. …
Article Rephine now offering QMS services to medical device companies through new partnership. Stevenage, Hertfordshire, 28 July, 2023 – Rephine, the experts in quality assurance & …
Case Study 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 …
General 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 …
REPHINE CHINA
REPHINE INDIA
Sign up to our newsletter to get the latest news about Rephine and industry news.