WHO TRS 986, 2014 Annex 2

WHO TRS (Technical Report Series) 

986, 2014 Annex 2


WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles 


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TABLE OF CONTENTS




INTRODUCTION


GENERAL CONSIDERATIONS


GLOSSARY 


QUALITY MANAGEMENT IN THE MEDICINES INDUSTRY: PHILOSOPHY AND ESSENTIAL ELEMENTS 


1.  PHARMACEUTICAL QUALITY SYSTEM

     Quality Risk Management

     Product Quality Review


2.  GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS 


3.  SANITATION AND HYGIENE 


4.  QUALIFICATION AND VALIDATION 


5.  COMPLAINTS 


6.  PRODUCT RECALLS


7.  CONTRACT PRODUCTION, ANALYSIS AND OTHER ACTIVITIES 

     General

     The Contract Giver 

     The Contract Acceptor 

     The Contract 


8.  SELF-INSPECTION, QUALITY AUDITS AND SUPPLIERS’ AUDITS AND APPROVAL 

     Items For Self-Inspection 

     Self-Inspection Team 

     Frequency Of Self-Inspection 

     Self-Inspection Report 

     Follow-Up Action 

     Quality Audit 

     Suppliers’ Audits and Approval 


9.  PERSONNEL 

      General 

      Key Personnel 


10.  TRAINING 


11.  PERSONAL HYGIENE 


12.  PREMISES 

       General 

       Ancillary Areas 

       Storage Areas 

       Weighing Areas 

       Production Areas 

       Quality Control Areas


13.  EQUIPMENT 


14.  MATERIALS 

       General 

       Starting Materials 

       Packaging Materials 

       Intermediate And Bulk Products 

       Finished Products 

       Rejected, Recovered, Reprocessed And Reworked Materials 

       Recalled Products 

       Returned Goods 

       Reagents And Culture Media 

       Reference Standards 

       Waste Materials 

       Miscellaneous 


15.  DOCUMENTATION 

       General 

       Documents Required 


16.  GOOD PRACTICES IN PRODUCTION 

       General 

       Prevention Of Cross-Contamination And Bacterial Contamination During Production 

       Processing Operations 

       Packaging Operations 


17.  GOOD PRACTICES IN QUALITY CONTROL 

       Control Of Starting Materials And Intermediate, Bulk And Finished Products 

       Test Requirements 

       Batch Record Review 

       Stability Studies 

       References


WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles, 

(Annex 2, WHO Technical Report Series 986, 2014) 

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