PDF-Working document QAS/13.522/Rev.1 7 July 2013 RESTRICTED

1 2 GUIDELINE ON SUBMISSION OF DOCUMENTATION FOR A 3 MULTISOURCE GENERIC FINISHED PHARMACEUTICAL 4 PRODUCT FPP QUALITY PART 5 REVISED DRAFT FOR COMMENT 6 7 8 9 10 11 12 World Health Organization. 521Rev August 2014 Document for comment GENERAL GUIDANCE 2157347575232 7057524573476786 REVISED DRAFT FOR COMMENT August 2014 10 11 12 13 14 15 16 17 18 19 20 21 DRAFT PROPOSAL ON A GENERAL METHOD FOR THE SUPPLEMENTARY INFORMATION SECTION OF THE FOURTH EDITION OF THE INTERNATIONAL PHARMACOPOEIA SOFTENING TIME DETERMINATION OF LIPOPHILIC SUPPOSITORIES (July 20 Presentation . #3. 12/11/2014. This presentation. defines confidential and restricted information. . and gives examples of data that should be destroyed. . . 1. Stay Tuned!. This is the THIRD in a series of presentations to help departments prepare for campus clean-up day.. IMPLEMENTATION OF THE REVISED GENERAL 
MONOGRAPH ON PARENTERAL PREPARATIONS IN THE 
INTERNATIONAL PHARMACOPOEIA: 
LIMITS FOR THE TEST FOR BACTERIAL ENDOTOXINS (3.4) 

DRAFT FOR COMMENT 


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