JVT Article:The Future of Process Validation-Going Back to Basics

View Larger Image

Price: $19.99

Quantity:

Add to a new shopping list

Item Number: JA1Q1073

Author: Miguel Montalvo

INTRODUCTION
The concept of Process Validation (PV) has evolved during the last 30 years and will continue to evolve in the future as our industry matures and the regulatory agencies move toward implementation of quality systems, Quality by Design (QbD), and global harmonization. The area of Process Validation was near and dear to Mr. Ken Chapman's interests and the perspectives presented in this article agree with his own point of view in relation to the topic.

Just to give you an historical perspective on the evolution of PV thus far:

• During the 1980's - companies (especially sterile and parenteral manufacturers) started to perform Process Validation without guidance from the Food and Drug Administration (FDA). During this time, companies developed aseptic processing and sterilization validations.

• 1987 - PV Guideline document from FDA is released. Solid dosage and oral products manufacturers start implementation of guideline. There is a great deal of confusion created by the terms “worst case” versus set-up at nominal value with a range of variability (parameter to remain within standard operating procedure (SOP) limits) during process validation. During his talks to industry, Ken Chapman also stressed the negative effects resulting from this confusion.

• Development areas were not documenting their processes adequately - Process validation was forced into challenging processes at worst cases, setting parameters at process limits, and even risking failure during validation. The focus was to comply with documentation requirements.

Product Reviews

(0 Ratings, 0 Reviews)

Browse Categories

Search

Stay In Touch

Login

JVT Article:The Future of Process Validation-Going Back to Basics

Product Reviews

Return Policy

About

Privacy Policy