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34965614 Pe009 9gmpguide Par Ti Basic Requirements for Medicinal Products 3

34965614 Pe009 9gmpguide Par Ti Basic Requirements for Medicinal Products 3

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PHARMACEUTICAL INSPECTION CONVENTIONPHARMACEUTICAL INSPECTION CO-OPERATION SCHEME
PE 009-9 (Part I) 1 September 2009
PE 009-9 (Part I)1 September 2009
GUIDE TO GOOD MANUFACTURINGPRACTICE FOR MEDICINAL PRODUCTSPART I
© PIC/S September 2009Reproduction prohibited for commercial purposes.Reproduction for internal use is authorised,provided that the source is acknowledged.Editor: PIC/S Secretariat14 rue du RoverayCH-1207 Genevae-mail:
 
info@picscheme.orgweb site:http://www.picscheme.org 
 
 
PE 009-9 (Part I)-
i
-1 September 2009
TABLE OF CONTENT
CHAPTER 1 - QUALITY MANAGEMENT...................................................................1
 
Principle...............................................................................................................1
 
Quality Assurance................................................................................................1
 
Good Manufacturing Practice for Medicinal products (GMP)................................2
 
Quality Control.....................................................................................................3Product Quality Review........................................................................................4Quality Risk Management....................................................................................5CHAPTER 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
 
 
Table of contents
PE 009-9 (Part I) - ii - 1 September 2009
CHAPTER 5 - PRODUCTION...................................................................................22
 
Principle.............................................................................................................22
 
General..............................................................................................................22
 
Prevention of cross-contamination in production................................................23
 
Validation...........................................................................................................24
 
Starting materials...............................................................................................24
 
Processing operations - Intermediate and bulk products....................................25
 
Packaging materials..........................................................................................25
 
Packaging operations........................................................................................26
 
Finished products..............................................................................................27
 
Rejected, recovered and returned materials......................................................28
 
CHAPTER 6 - QUALITY CONTROL.........................................................................29
 
Principle.............................................................................................................29
 
General..............................................................................................................29
 
Good Quality Control Laboratory Practice..........................................................30
 
Documentation..................................................................................................30
 
Sampling............................................................................................................30
 
Testing...............................................................................................................31On-going Stability Programme...........................................................................32CHAPTER 7 - CONTRACT MANUFACTURE AND ANALYSIS................................35
 
Principle.............................................................................................................35
 
General..............................................................................................................35
 
The Contract Giver............................................................................................35
 
The Contract Acceptor.......................................................................................36
 
The Contract......................................................................................................36
 
CHAPTER 8 - COMPLAINTS AND PRODUCT RECALL..........................................38
 
Principle.............................................................................................................38
 
Complaints.........................................................................................................38
 
Recalls...............................................................................................................39
 
CHAPTER 9 - SELF INSPECTION...........................................................................40
 
Principle.............................................................................................................40
 

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