|
The FDA and EMA both stress the importance of equipment qualification.
|
If you can’t prove that your equipment, operations and processes all work the way they’re supposed to, you can’t reliably produce a quality product and pass regulatory muster.
This report — authored by international GMP expert Thomas Peither and associates — lays out the basics of building a four-phase qualification plan… design qualification, installation qualification, operational qualification and performance qualification… that satisfies US and EU requirements. It covers:
-
Building a qualification team
-
Formulating a qualification plan
-
Documenting qualification results
-
Using risk analysis methods to evaluate equipment’s impact on the manufacturing process
The following bonus materials are included in the report:
-
Instructive diagrams
-
Checklists for carrying out a qualification plan
-
FDA guidance Principles of Process Validation and
-
EU GMP guidelines’ Annex 15, Qualification and Validation.
Order your copy of Principles of Equipment Qualification and understand the four phases of qualification.
Order Your Copy Today
PDF Edition
|
|
Available Format |
|
PDF Edition — $397
Table of Contents
- Introduction
- Official Requirements and Agency Expectations
- Design Qualification
- Installation Qualification
- And More …
View the entire TOC
About the Authors
Thomas Peither and associates
Thomas Peither has been a GMP consultant for 18 years and an expert in the European GMPs. He cofounded the GMP publishing company Maas & Peither (Germany, USA) and the midsize pharma consulting company Halfmann Goetsch Peither (Switzerland, Germany, Singapore), which advises numerous pharmaceutical companies.
Who Will Benefit
- Quality assurance/control
- Engineering staff
- Equipment managers
- Production head
- Systems designers
Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.
|
|
|
