Principles of Equipment Qualification A Guide for Drug and Device Manufacturers
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:
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.
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.
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