Validating Medical Packaging: 1st Edition (e-Book) book cover

Validating Medical Packaging

1st Edition

By Ronald Pilchik

CRC Press

160 pages

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Hardback: 9781566768078
pub: 2002-09-27
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eBook (VitalSource) : 9780429134852
pub: 2002-09-27
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According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instruc

Table of Contents

INTRODUCTION. What is Validation? PACKAGE DESIGN VALIDATION. Elements of Package Design. Package Design Issues. Validation Flow Chart. Simulation Criteria. Qualified Suppliers. PACKAGE PROCESS VALIDATION. Introduction. Process Validation. IQ, OQ, PQ. Process Capability Studies. Example. PUTTING IT ALL TOGETHER: THE VALIDATION PROTOCOL. The Validation File. File Maintenance. Employing the Process. Example. REGULATORY ACTIVITIES. Selected Case Studies. Packaging Non-Compliances. Industry Generated Support Documents. HACCP. Appendix.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
TECHNOLOGY & ENGINEERING / Industrial Design / Packaging