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What is ISO 15378 Certification | Primary Packaging Material for Medical Device What is ISO 15378 Certification | Primary Packaging Material for Medical DeviceTopic Cover:1. What is ISO 15378 - Primary Packaging Material for Medical Devi...

ISO 9001:2015 & cGMP similarities
Both require:
• Written records and procedures appropriate to the processes taking place
• A control process for these records and procedures
• That personnel are properly trained and qualified to perform their jobs
• That work environments are properly maintained
• That customer complaints and nonconformances are addressed, and that appropriate corrective actions are taken to prevent recurrences
• That equipment be maintained and calibrated
• That products be properly identified throughout the manufacturing cycle
• That there be product release procedures , analysis of product, and conformance to specifications prior to release
• Appropriate quarantining and control of nonconforming product to prevent its release to the marketplace
• The application of good scientific principles and statistical techniques
also risk base thinking (differ in implementation but spirit is similar .

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