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GMP AND cGMP CONSIDERATIONS Dr. Basavaraj K. Nanjwade  M.Pharm., Ph.D. Associate Professor Department of Pharmaceutics KLE University BELGAUM - 590010 By
What is GMP ? ,[object Object],[object Object]
What is cGMP ? ,[object Object]
Quality Definition ,[object Object],[object Object],[object Object],[object Object]
 
Good Manufacturing Practices ,[object Object],[object Object]
Some of the main risks are ,[object Object],[object Object],[object Object]
Why GMP is important ,[object Object],[object Object]
GMP helps boost pharmaceutical export opportunities ,[object Object],[object Object]
GMP Covers… ,[object Object],[object Object],[object Object]
GMP ,[object Object],[object Object],[object Object],[object Object]
QA, GMP & QC inter-relationship QC GMP QA
QA, GMP & QC inter-relationship ,[object Object],QA
QA, GMP & QC inter-relationship ,[object Object],GMP
QA, GMP & QC inter-relationship ,[object Object],QC
QC and QA ,[object Object],[object Object],[object Object]
QC and QA ,[object Object],[object Object]
QC and QA ,[object Object],[object Object]
GMP guidelines ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
GMP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
GMP ,[object Object],[object Object],[object Object],[object Object],[object Object]
GMP ,[object Object]
Ten Principles of GMP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Beyond GMP ,[object Object],[object Object],[object Object],[object Object],[object Object]
Cost of effective GMP ,[object Object],[object Object],[object Object],[object Object]
List of important documents  in GMP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
10 attributes of a good document ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Certifying agencies ,[object Object],[object Object],[object Object],[object Object]
How do GMPs of different countries compare? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
cGMP For Finished Pharmaceuticals ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
General Provision ,[object Object],[object Object]
Organization & Personnel ,[object Object],[object Object],[object Object],[object Object]
Building & Facilities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Equipment ,[object Object],[object Object],[object Object],[object Object],[object Object]
Control of Components & Drug Product Containers & Closures ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Production & Process Control ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Packaging & Labeling Control ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Handling & Distribution ,[object Object],[object Object]
Laboratory Control ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Records & Reports ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Returned & Salvaged Drug Products ,[object Object],[object Object]
[object Object],E-mail:  [email_address] Cell No: 9448716277

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  • 1. GMP AND cGMP CONSIDERATIONS Dr. Basavaraj K. Nanjwade M.Pharm., Ph.D. Associate Professor Department of Pharmaceutics KLE University BELGAUM - 590010 By
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