Principles of Equipment Qualification
A Guide for Drug and Device Manufacturer - PDF Download
Excerpt from the GMP Compliance AdviserA Guide for Drug and Device Manufacturers - learn more about the four phases of qualification.
Excerpt from the GMP Compliance Adviser 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 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
- Instructive diagrams
- Checklists for carrying out a qualification plan
- FDA guidance Principles of Process Validation and
- EU GMP guideline Annex 15, Qualification and Validation.
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