Transcription of M4Q Implementation Working Group Questions & …
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M4Q Implementation Working Group Questions & …
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH Secretariat, c/o IFPMA,15, chemin Louis-Dunant, Box 195, 1211 Geneva 20, Switzerland Telephone: +41 (22) 338 32 06 Telefax: +41 (22) 338 32 30 E-mail : Web site : M4Q Implementation Working Group Questions & Answers (R1) Current version dated July 17, 2003 In order to facilitate the Implementation of the CTD Quality (M4Q) guideline, the ICH Experts have developed a series of Q&As: M4Q Q&As Document History First Codification History Date New Codification November 2005 M4Q Q&As Approval by the Steering Committee.
should be presented in separate Drug Product sections for the drug product and the reconstitution diluent. These could be titled 3.2.P (Drug Product) and 3.2.P (Diluent).
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