(www.ubio.in) Drug License Audit in India

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Presentation Description

Drug regulatory requirements in India, Free audit checklist (high-level) on drug licensing for pharma, ivd consultants and manufacturers.

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Presentation Transcript

Slide1: 

Drug License Audit in India What do the auditors look for?

Slide2: 

Preparing for Audit

Slide3: 

Audit team

Slide4: 

What do the auditors inspect? Materials Management Documentation Quality Control

Slide5: 

Personnel

Slide6: 

Premises

Slide7: 

Storage and Packing

Slide8: 

Production

Slide9: 

Materials Management

Slide10: 

Documentation

Slide11: 

Quality Control

Slide12: 

Things to remember

Slide13: 

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