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Pics Gmp Guidance

Pics Gmp Guidance

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Published by Rambabu komati - QA

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Published by: Rambabu komati - QA on Jul 27, 2008
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08/25/2012

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PHARMACEUTICAL INSPECTION CONVENTIONPHARMACEUTICAL INSPECTION CO-OPERATION SCHEME
1 July 2004 PE 009-2
PE 009-2
1 July
2004
GUIDE TO GOOD MANUFACTURINGPRACTICE FOR MEDICINAL PRODUCTS
 © PIC/S July 2004Reproduction prohibited for commercial purposes.Reproduction for internal use is authorised,provided that the source is acknowledged.Editor: PIC/S SecretariatP.O. Box 5695CH-1211 Geneva 11e-mail:
 
daniel.brunner@picscheme.org
 web site:
http://www.picscheme.org
 
 
Table of contents
1 July 2004 - i - PE 009-2
TABLE OF CONTENT
INTRODUCTION...............................................................................................................1
 
CHAPTER 1 - QUALITY MANAGEMENT......................................................................3
 
Principle....................................................................................................................3
 
Quality Assurance....................................................................................................3
 
Good Manufacturing Practice for Medicinal products (GMP)..................................4
 
Quality Control..........................................................................................................5
 
CHAPTER 2 - PERSONNEL...........................................................................................7
 
Principle....................................................................................................................7
 
General.....................................................................................................................7
 
Key Personnel..........................................................................................................7
 
Training.....................................................................................................................9
 
Personal Hygiene.....................................................................................................9
 
CHAPTER 3 - PREMISES AND EQUIPMENT.............................................................11
 
Principle..................................................................................................................11
 
Premises.................................................................................................................11
 
General.........................................................................................................11Production Area............................................................................................11Storage Areas...............................................................................................13Quality Control Areas....................................................................................13Ancillary Areas..............................................................................................14
 
Equipment..............................................................................................................14
 
CHAPTER 4 - DOCUMENTATION...............................................................................15
 
Principle..................................................................................................................15
 
General...................................................................................................................15
 
Documents required...............................................................................................16
 
Specifications................................................................................................16
 
Specifications for starting and packaging materials.....................................16
 
Specifications for intermediate and bulk products.......................................17
 
Specifications for finished products..............................................................17
 
Manufacturing Formula and Processing Instructions............................................17
 
Packaging Instructions...........................................................................................18
 
Batch Processing Records.....................................................................................18
 
Batch Packaging Records......................................................................................19
 
Procedures and records.........................................................................................20
 
Receipt..........................................................................................................20
 
Sampling.......................................................................................................20
 
Testing..........................................................................................................21
 
Other.............................................................................................................21
 

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