Process Validation Toolkit

The fundamental principle of process validation is to ensure products are manufactured in accordance with the intended use, quality, safety, and efficacy are designed or built into the product, quality cannot be tested or inspected into the final product, and each step in a manufacturing process is controlled to assure that the finished product meets all design characteristics and quality attributed including specifications. This guidance will provide a pathway for navigating the major regulatory process qualification requirements and discuss current regulatory submission feedback to meet compliance...

The purpose of the validation plan is to demonstrate that the critical equipment, systems, and processes perform as designed and intended.  All validation will be conducted prospectively following written and approved protocols.  Change control and qualification of equipment and systems will be conducted in a manner consistent with a company's policies and procedures.  Specific equipment, systems, and processes to be validated will be determined based on a documented risk assessment.  Download the example Validation Master Plan.Download the accompanying presentation "Writing...

This is Part II to IVT's three-part special edition series on process validation. This special edition is a collection of articles and papers from the Journal of Validation Technology and the Journal of GXP Compliance and focuses on equipment qualification, process qualification documentation, quality risk management, and compliant sampling. Introduction to FDA Stage 2: Process Qualification The testing performed in this process validation stage confirms that the process design is capable of manufacturing drug product at commercial scale in accordance with the process...

This special edition is a collection of articles and papers from the Journal of Validation Technology and the Journal of GXP Compliance that expound such topics as knowledge building with probability distributions, a step-by-step process for design-of-experiment, quality-by-design, and hypothesis testing, this e-Book will firmly establish the scientific foundations of a manufacturing process.Table of Contents

This is Part III of IVT's special edition series on process validation. A collection of papers and articles from the Journal of Validation Technology and the Journal of GXP Compliance, this e-Book covers controlling and reducing variation, revalidation, managing analytical error, and the process nonconformity concept Introduction to FDA Stage 3: Continuing Process Verification This stage may be simply described as “maintaining validation” or “maintaining the validated state.” Maintenance activities of Stage 3 should be commensurate with the risk identified for the...

Sampling is a key current good manufacturing practice (cGMP) activity that impacts nearly every activity of manufacturing pharmaceutical products. Sampling is used during the assessment of raw materials, labeling, and components prior to release, validation of equipment, processes, systems, and products; products during production; finished products prior to release; products during stability studies; and data before, during, and after productionThe appropriate knowledge and application of cGMP requirements for sampling is critical to the development of a scientifically sound quality...

This webinar will discuss the fundamentals of effective and US Food and Drug Administration-compliant process validation. The background to FDA's Process Validation: General Principles and Practices will be discussed, and the requirements will be analyzed. Attendees will learn how to apply and implement this guidance into cleaning and method validation, equipment and facility qualification, and quality systems.

Sessions include:Process Validation—A Lifecycle Approach that Overcomes the Top Ten Validation ChallengesIntroduction to Statistics in Lifecycle Process ValidationImplement Quality Risk Managment (QRM) into GMP and Validation Environments Enterprise-wideLifecycle Managment of Qualification and Validation—Implement EU's Annex 15 while Harmonizing with U.S. GMPs and GuidelinesUnderstand the FDA's Quality Metrics 2015 Guidance and the Effect on Validation—What You Need to Know!Validation Sampling Plans and Acceptance CriteriaChallenges, Opportunities, and Strategies, for Green (Paperless) ValidationUnderstandDocumentation...

22st Annual Validation Week Highlights include:Over 40 Sessions All Dedicated to Validation and GMP Practice  Explore the practical and advanced presentations on validation execution which Include both “nuts-and-bolts” and “advanced” materials.Presentations by the“Crème de la Crème” of Validation Experts in the FDA Regulated IndustryThe speaking faculty for the 22nd Annual Val Week included the most experienced validation and compliance professionals from regulatory agencies, pharmaceutical, biotech and medical device industries, and selected technology and software providers....