In this video Best Practices for USFDA preparation are discussed.
This is in continuation of the previous sessions of 5 "R" s of the Pharmaceutical Industry.
RETURNS CONCERNING API MANUFACTURING COMPANY.
1) Proper labeling is important.
2) Proper segregation is necessary.
3) Think about the next step in advance.
4) Update at your computer system.
5) Storage and shipping condition of the return material.
6) Presence of original seal.
7) Damage to the primary packing.
8) Labeling of the material.
9) Disposition Decision.
In any organization manufacturing high quality product is the Key to success
1) Should have differentiation.
2) Everytime same principal is not applicable.
3) Rejection word is only applicable only when there is approved specification.
4) Just pasting the label of rejection is not permitted.
5) Status of the material should be clear.
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Dr. Rupali Paranjape is a passionate Auditor, Trainer, Consultant & Implementer for Pharmaceutical Industry.
She is also Best Selling Author of the book " Blue Ocean of Compliance".
Contact details of Author Dr. Rupali Paranjape
Mail: mail@drrupaliparanjape.com
Website: www.drrupaliparanjape.com
Watsapp no. + 91-73838 06368
Catch her on
KZitem Channel: www.youtube.co...
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Blue Ocean of Compliance
Holistic Approach Towards Achieving Regulatory Compliance for Pharmaceutical Industries with No-Observation
Are you struggling to solve the problems of non-compliances on your site?
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About the Book
“Blue Ocean of Compliance” is a book employing a one-of-a-kind thought process for achieving compliance with no-observation.
It takes you through a guide of Regulatory Inspections elaborated with the US Regulatory Market regard.
This book will not only equip you with regulatory knowledge but will also empower you to solve complicated non-compliances, in the context of factors that we do not even think of. The ideas in this book are very simple to understand.
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