Validation is creating an evidence trail to show that an action, method, or system leads to a consistent and reproducible result. Validation is the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process or components of a process can consistently deliver a quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process.
PE Articles
Process Validation Lifecycle Implementation for Existing (“Legacy”) Products
This Discussion Paper examines some of the topics and challenges related to the implementation of…
PE Articles
Process Validation in Context of Small Molecule DS and DP Continuous Manufacturing Processes
This Discussion Paper discusses considerations for process validation (PV) activities with a…
PE Articles
Process Validation Lifecycle for Packaging Oral Solid Dosage Forms
The ISPE Discussion Paper “Overview of Packaging Validation for Drug Products” explores the…
PE Articles
Validation & Data Integrity in eClinical Platforms
To address the trial specific setups, eClinical solutions have to be built from various integrated…
iSpeak Blog
Practice the ISPE Good Practice Guide Series – Expert Workshops at the 2024 ISPE Annual Meeting & Expo
Building off the success of the 2023 ISPE Annual Meeting & Expo, the program committee has developed…
PE Articles
FDA’s 2011 Process Validation Guidance: 10 Years On
In 2011, the US Food and Drug Administration (FDA) introduced the revised “Guidance for Industry…
Product
GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
Published: July 2024 Pages: 258 Table of Contents Special Pricing for Emerging Economies Advances in…
PE Articles
Pharma Facilities, Composable Tools, and Validation 4.0
The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies…
PE Articles
Evaluation of Impact of Statistical Tools on Process Performance Qualification (PPQ) Outcomes
This discussion paper uses segments of typical validation case studies (validation of key attributes…
PE Articles
Stage 2 Process Validation: Process Performance Qualification Batches
The purpose of this paper is to stimulate further discussion and suggest potential practical…
PE Articles
Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations
This paper discusses the nuances of lifecycle validation implementation at contract manufacturing…
PE Articles
Determining Number of Process Performance Qualification Batches Using Statistical Tools
This is the second discussion paper written by the ISPE Process Validation (PV) Team on the topic of…
PE Articles
Process Validation Lifecycle Implementation for Existing (“Legacy”) Products
This Discussion Paper examines some of the topics and challenges related to the implementation of…
PE Articles
Process Validation in Context of Small Molecule DS and DP Continuous Manufacturing Processes
This Discussion Paper discusses considerations for process validation (PV) activities with a…
PE Articles
Process Validation Lifecycle for Packaging Oral Solid Dosage Forms
The ISPE Discussion Paper “Overview of Packaging Validation for Drug Products” explores the…
PE Articles
Validation & Data Integrity in eClinical Platforms
To address the trial specific setups, eClinical solutions have to be built from various integrated…
iSpeak Blog
Practice the ISPE Good Practice Guide Series – Expert Workshops at the 2024 ISPE Annual Meeting & Expo
Building off the success of the 2023 ISPE Annual Meeting & Expo, the program committee has developed…
PE Articles
FDA’s 2011 Process Validation Guidance: 10 Years On
In 2011, the US Food and Drug Administration (FDA) introduced the revised “Guidance for Industry…
Product
GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
Published: July 2024 Pages: 258 Table of Contents Special Pricing for Emerging Economies Advances in…
PE Articles
Pharma Facilities, Composable Tools, and Validation 4.0
The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies…
PE Articles
Evaluation of Impact of Statistical Tools on Process Performance Qualification (PPQ) Outcomes
This discussion paper uses segments of typical validation case studies (validation of key attributes…
PE Articles
Stage 2 Process Validation: Process Performance Qualification Batches
The purpose of this paper is to stimulate further discussion and suggest potential practical…
Guidance Documents
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+Lifecycle Management (1)
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Apr 16, 2025
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Mar 28, 2025
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Pharmaceutical Engineering Magazine Articles
Validation of Aseptic Processes Using Media Fill
Aseptic process simulation (APS) is essential for validation of an aseptic manufacturing process and…
AI Maturity Model for GxP Application: A Foundation for AI Validation
Artificial intelligence (AI) has become one of the supporting pillars for digitalization in many…
Master Soil Selection for Cleaning Validation of Parts Washers
One of the goals of the cleaning validation design phase is to define critical process parameters…
Data Science for Pharma 4.0™: Drug Development, & Production—Part 2
This second of a two-part series explores digital transformation and digitalization in the…
Automating MACO Calculations in Cleaning Validation
For a multiproduct facility where equipment is shared, there is always a risk from cross…
FDA’s 2011 Process Validation Guidance: 10 Years On
In 2011, the US Food and Drug Administration (FDA) introduced the revised “Guidance for Industry…
Pharma Facilities, Composable Tools, and Validation 4.0
The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies…
In-Silico Data-Driven Mechanistic Model–Assisted Process Validation
The US Food and Drug Administration (FDA) advocates for the integration of quality by design (QbD)…
Risk- And Science-Based Media and Buffer Mixing Validations
The validation of media and buffer mixing is a continuing area of resource constraint in the…
Validation 4.0: Case Studies for Oral Solid Dose Manufacturing
Three case studies on Validation 4.0 demonstrate how quality by design (QbD) principles, when…
Reimagining CPV for a Pharma 4.0™ World
The life cycle approach to process validation stresses the need for continued monitoring of process…
Lessons Learned in Global CQV
Global commissioning, qualification, and validation (CQV) project delivery has in recent years been…
Validation of Aseptic Processes Using Media Fill
Aseptic process simulation (APS) is essential for validation of an aseptic manufacturing process and…
AI Maturity Model for GxP Application: A Foundation for AI Validation
Artificial intelligence (AI) has become one of the supporting pillars for digitalization in many…
Master Soil Selection for Cleaning Validation of Parts Washers
One of the goals of the cleaning validation design phase is to define critical process parameters…
Data Science for Pharma 4.0™: Drug Development, & Production—Part 2
This second of a two-part series explores digital transformation and digitalization in the…
Automating MACO Calculations in Cleaning Validation
For a multiproduct facility where equipment is shared, there is always a risk from cross…
FDA’s 2011 Process Validation Guidance: 10 Years On
In 2011, the US Food and Drug Administration (FDA) introduced the revised “Guidance for Industry…
Pharma Facilities, Composable Tools, and Validation 4.0
The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies…
In-Silico Data-Driven Mechanistic Model–Assisted Process Validation
The US Food and Drug Administration (FDA) advocates for the integration of quality by design (QbD)…
Risk- And Science-Based Media and Buffer Mixing Validations
The validation of media and buffer mixing is a continuing area of resource constraint in the…
Validation 4.0: Case Studies for Oral Solid Dose Manufacturing
Three case studies on Validation 4.0 demonstrate how quality by design (QbD) principles, when…
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March / April 2024
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…
Lifecycle Approach to Biotech Process Validation
This discussion paper proposes ideas for answering the questions about the application of the…
Stage 3 Process Validation: Applying Continued Process Verification Expectations
This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and…
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