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
FDA’s 2011 Process Validation Guidance: 10 Years On
In 2011, the US Food and Drug Administration (FDA) introduced the revised “Guidance for Industry…
PE Articles
2024 State of Validation Report
Unlock the latest insights and trends in validation practices with the 2024 State of Validation…
PE Articles
The CDMO Handbook: Overcoming Industry Challenges With Digital Validation
Contract Development and Manufacturing Organizations (CDMOs) and Contract Manufacturing…
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…
Guidance Documents
Data Integrity (11)
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
GAMP® (12)
- GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Lifecycle Management (1)
Microbiological & Viral Contamination Control (1)
Quality Assurance (1)
Validation (14)
- GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
- Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- Good Practice Guide: Process Validation
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
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Pharmaceutical Engineering Magazine 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…
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…
Webinars
White Papers
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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Featured Conferences
Professional Development Training
Requirements for Computerized Systems Validation and Compliance
This online course describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. It does not cover the detailed requirements of 21 CFR Part 11, except for the requirement that systems be validated. Even though it draws upon medical device guidance, it is not intended to cover all the requirements of producing software that subsequently becomes part of a medical device.
Basic Principles of Computerized Systems Compliance
Basic Principles of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-Based Approach to Compliant GxP Computerized Systems This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an…
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Commissioning and Qualification Training Course
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.
Process Validation Training Course
This training course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System.
Pharmaceutical Technology Transfer Training Course
This training course on Pharmaceutical Technology Transfer identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer.
Process Validation Biotechnology Manufacturing Training Course
This training course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required to validate biopharmaceutical processes.