Food & Drug Administration (FDA)
Code of Federal Regulations & ICH Handbooks

GMP Publications, Inc., GXPNews & FDA.COM

Tel: 856-810-7331  Fax: 856-810-7339    sales@gmppublications.com 

send logos to: art@gmppublications.com

CFR Rule Changes by GXPNews

HomePharma GMPsMedical DeviceClinicalFood-Diet-CosmeticBiologic-Cell-BloodLaboratoryPart 11EU-Can-Misc.

New Additions
ICH Master Q Series Parts Q7, Q8, Q9 & Q10
Part 111 Good Manufacturing Practices for Dietary Supplements

Part 111 Good Manufacturing Practices for Dietary Supplements and Part 11 Electronic Records

Recent Customized Handbooks - 25 book minimum
Parts 11, 50, 54, 56, 58, 312, 314, ICH E2A, ICH E6 and EU Clinical Trial Directive
50.54.56.200.201.203.210.211.kw.312.314.600.601.610.ICH E6.E8.Q7A
11.58.210.211.600.820.ICH Q7A
11.210.211.600.820.ICH Q7A
600.601.610.820.1270.1271
11.50.54.56.312.314.812.814.ICH E2A.E6
50.54.56.801.803.806.807.810.812.814.820.510K.PMA
210.211.ICH Q7A
11.50.54.56.312.812.814.ICH E2A.E6
11.210.211.kw.600.601.610.ICH Q7A
11.58.210.211
11.50.54.56.312.812.ICH E2A.E6.EU
11.210.211.820.ICH Q7A.Q8
11.50.54.56.812.814.ICH E2A.E6
600.601.610.ICH Q5E
11.58.ICH Q2B
11.801.803.806.820.821.822.ICH Q9
11.210.211.ICH Q1A.Q1E.Q7A.Q9
58.ICH M3.S6.S7A
11.210.211.600.601.610.820.ICH Q7A.Q8.Q9
11.210.211.600.601.606.610
11.58.210.211.600.601.610.820.ICH Q7A,Q8.Q9
50.54.56.812.814.1271.ICH E8
11.210.211.600.820.ICH Q7A
820.1271
11.58.210.211.600.601.610.820.ICH Q7A
11.58.312.314.600.601
210.211.600.601.606.607610.630.640.660.820.1270.1271.42 CFR 493
11.11 Preambles.50.54.56.200.201.203.210.211.312.314.316.600.601.ICH Q7A E2A E6.Title 45 Part 46

 
Copyright©1998 - 2007 GMP Publications, Inc., FDA.COM and GXPNews
GMP Publications, Inc. P.O. Box 335, Medford, NJ 08055   856-810-7331   sales@gmppublications.com