eBook - ePub
GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package)
- 448 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package)
About this book
Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these
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Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app.
Yes, you can access GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package) by Leonard Steinborn in PDF and/or ePUB format, as well as other popular books in Medicine & Medical Theory, Practice & Reference. We have over one million books available in our catalogue for you to explore.
Information
Section II
QUALITY AUDIT CHECKLISTS
• Internal Device Manufacturer/Developer Audit Checklist
– For audit of internal quality systems utilized by a medical device company
• Internal Drug Manufacturer/Developer Audit Checklist
– For audit of internal quality systems utilized by a pharmaceutical company
• Contract Device Manufacturer/Developer Audit Checklist
– For use when evaluating an operation that manufactures or develops a medical device product or assembly for another company
• Contract Drug Manufacturer/Developer Audit Checklist
– For use when evaluating an operation that manufactures or develops a drug product for another company
• Contract Software Developer Audit Checklist
– For evaluating a source that develops software. For auditing contract software-manufacturing operations, refer to the Contract Device Manufacturer/Developer Audit Checklist
• General Supplier Audit Checklist
– For evaluating a supplier that produces plastic, metal, rubber, or paper (nonprinted) products
• Bulk Chemical Supplier Audit Checklist
– For evaluation of a bulk chemical manufacturing operation. If the supplier custom formulates a completed dosage form for someone, the Contract Drug Manufacturer/Developer Audit Checklist would be more appropriate to use
• Printed Material Supplier Audit Checklist
– For evaluation of a source that produces a printed component
• Electronic Component Supplier Audit Checklist
– For evaluating a source that produces electronic parts or subassemblies
• QSIT Audit (New FDA Inspection Approach) for Medical Devices Checklist
– For evaluating the capability of a device company to accommodate a QSIT audit
• QSIT Audit (New FDA Inspection Approach) for Drug Company Checklist
– For evaluating the capability of a drug company to accommodate a QSIT audit
• New Product Market Launch Checklist
– For use as a final audit for GMP and ISO compliance prior to releas...
Table of contents
- Cover
- Title Page
- Copyright Page
- Table of Contents
- Introduction
- About the Author
- Preface
- Documents Referenced in the Checklists
- How To Use This Manual
- Section I Quality Audit Purpose and Practice
- Section II Quality Audit Checklists