Continuous Education by Perfect Pharmaceutical Consultants Pvt. Ltd, Pune, India © Perfect Pharmaceutical Consultants Pvt. Limited, November 2012 1 TYPICAL FDA COMMENTS ON IMPURITY PROFILING IN CTD/CEP/DMF SUBMISSIONS By Rajkumar Gupta, Managing Director Perfect Pharmaceutical Consultant Pvt. Ltd and Director Global Institute of Regulatory affairs, Pune Mr. R.M. Gupta (M. Pharm.), is a free lancer consultant for US DMF, COS, ANDA, ACTD, CTD, eCTD and other regulatory submissions. guptarmg1952@gmail.com He is associated with Perfect Pharmaceutical Consultants Pvt. Limited (http://sites.google.com/site/ppcdmf ) and Global Institute of Regulatory affairs (Pune, India). He is dedicated solely to pharmaceutical regulatory profession. He is well recognized GMP auditor and cGMP Trainer of Trainers (cGMP TOT) for Pharmaceuticals (Parenteral/Liquid Orals/ Tablets/Capsules/Vaccines/Beta lactam) /API/Herbal/Medical Devices/ manufacturing Facilities He is also an expert on Impurity Profiling This article is solely written by him to guide, educate and train young Regulatory, QC and QA personnel at large. The article is based on self experience of 25 years of the author 1. INTRODUCTION Impurity profiling is a highly intelligent, tedious and expensive task in standardizing the drug products for marketing Authorization. This task usually more complex when the proper impurity standards are not available and synthesis of the same require extra ordinary high cost and time. It has been observed that many a time application for ANDA/DMF/CEP is delayed due to extra ordinary delay in compiling impurity profiling. Further, the approval of many of drug product is denied for inadequate impurity profiling. This article provides typical FDA comments on data on impurity profiling included in Regulatory submissions for marketing Authorization. The purpose of the article is to assist the regulatory professionals to understand the FDA perspective on Impurity Profiling and to avoid queries on the same. Many of the queries are referenced from FDA 483 Notes and Scientific Discussions available on the internet.