Process Validation

Video

Data Science Workflows for Process Characterization Webinar

Complimentary Learning Level: Intermediate/Advanced Session Length: 1.5 hours Process validation stage 1, also known as process characterization (PCS), is the main step of generating process knowledge that is reported in...
Validation of Clinical Trial–Related Systems in Smaller Enterprises
Features
Validation of Clinical Trial–Related Systems in Smaller Enterprises

Existing risk-based approaches to computerized system compliance and validation as outlined in GAMP® 51  are applicable to a variety of life sciences organizations...

  • 1International Society for Pharmaceutical Engineering. GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems. North Bethesda, MD: International Society for Pharmaceutical Engineering, 2008.
Figure 1: Batch simulation using MVDA
Technical
Continued Process Verification in Stages 1–3

Continued process verification (CPV) as defined in the US FDA process validation guideline1 helps bring quality management and compliance in the pharmaceutical industry to the next level, but it has been challenging to...

  • 1US Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” 2011. https://www.fda.gov/media/71021/download
Video

Practical Implementation of the Lifecycle Approach to Process Validation Webinar

Lifecycle Process Validation guidance has been published by FDA in 2011 and by PIC/S and EMA in 2015. This guidance reflects ICH guidance on enhanced development and product quality monitoring practices using approaches...
Online Live Training
Online Live

Practical Implementation of Process Validation Lifecycle Approach Online Live Training

Online Live Overview Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry. How many lots should I make? Are we taking enough samples? Do we...
Discussion Paper
Guidance Docs

Process Validation Lifecycle for Packaging Oral Solid Dosage Forms

In August 2017, ISPE published the Discussion Paper “Overview of Packaging Validation for Drug Products,” which explores the different ways to...
Video

ISPE Good Practice Guide: Process Validation

Guide contributor (co-lead) Robert Beall, PMP, ProPharma Group, shares why process validation is an essential part of the pharma industry and how you’ll benefit from the ISPE Good Practice Guide: Practical Implementation...
Video

ISPE Training: Process Validation Takeaways

ISPE training instructor, Maurice Parlane, B Tech MIT, New Wayz Consulting Ltd., CBE Pty Ltd., shares the top three takeaways you will gain by attending ISPE process validation training. Register Now For even more on...