Transcription of NfG on Maximum shelf-life for sterile products for human use
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NfG on Maximum shelf-life for sterile products for human use
The European Agency for the Evaluation of Medicinal ProductsHuman Medicines Evaluation Unit7 Westferry Circus, Canary Wharf, London E14 4HB, UKSwitchboard: (+44-171) 418 8400 Fax: (+44-171) 418 8447E_Mail: EMEA 1999 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledgedLondon, 28 January 1998 CPMP/QWP/159/96 corrCOMMITTEE FOR PROPRIETARY MEDICINAL products (CPMP)NOTE FOR GUIDANCE ONMAXIMUM shelf-life FOR sterile products FOR HUMANUSE AFTER FIRST OPENING OR FOLLOWING RECONSTITUTIONDISCUSSION IN THE QUALITY WORKING PARTY (QWP)June 1995 October 1995 February 1996 TRANSMISSION TO THE CPMPJune 1996 release FOR CONSULTATIONJune 1996 DEADLINE FOR COMMENTSD ecember 1996 TRANSMISSION TO CPMPJune 1997 release FOR SECOND PERIOD OF CONSULTATIONJune 1997 DEADLINE FOR COMMENTSS eptember 1997 APPROVAL BY CPMPJ anuary 1998 DATE FOR COMING INTO OPERATIONJuly 1998 CPMP/QWP/159/96 EMEA 19991/1 Maximum shelf-life FOR sterile products FOR HUMANUSE AFTER FIRST OPENING OR FOLLOWING RECONSTITUTIONGENERAL STATEMENT.
RELEASE FOR CONSULTATION June 1996 DEADLINE FOR COMMENTS December 1996 ... This guidance applies to all sterile products for human use, with the exception of Radiopharmaceuticals and extemporaneously prepared or modified preparations. Because it is difficult to predict all the possible conditions under which the product will be opened, diluted ...
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