Rajkumar Gupta, M.Pharm. . Regulatory Mentor at Perfect Pharmaceutical consultants Pot Limited, India. 1 provide professional regulatory services on cGMP Audits/Training, ANDA, NDA IND, CEP, DMF, PV. PSUR, Contact pesfectdossiers@ gmail.com vist: www.perfectdossier com ‘The five core members are : US, Europe, Australia, Japan and inacla 17. | Does FDA protect FDA maintains the strict confidentiality of all the proprietary /confidential | submissions from unauthorized display or access information of applicants? | from public. 18. | Why Pharmacovigilance is | Pharmacovigilance is the continuous tracking of necessary? the safety, efficacy and adverse effects of the drugs following its release in the market. 19. | What is PSUR? It is the periodic assessment of the adverse effects of the drugs once it is released in the market. 20. | What is access control It is acontrol over access to information stored on computers and other electronic devices 21. | What is data integrity? | It is the truthfulness and completeness of data 22. | What are the contents of _ | CTD Module 3 consist of two parts, CTD Module 3? ‘The Substance part and Product part ‘The substance part provides the quality details on API used in the product. ‘The Product part provides quality details on the final product 23. | What particulars shall be | Product Name provided in patent Name of patent holder certificate? Patent No Patent issue date Patent Expiry Date Pediatric Exclusivity if any Patent Extension ifany 24. | What is Site Master File? | The file giving complete information of the site where the product is manufactured analyzed and stored for distribution. It also provides details on connected contract sites where the product processed or analyzed. 25. | What is data cloning? It is customization of data for one application to another similar application This term when used with reference to eCTD, it means customization of data for one region to another region. 26. | What are the two essential | (1) CTD/eCTD ,DMF,CEP requirements for 2)Site Audit for CGMP Compliance Marketing Authorization? 27. | Why the drug products are | The impurities in drug products can either modify controlled for impurities? the drug actions or can induce toxic effects. © Copyright by Mr. Rajkumar Gupta, August 2014 india. All rights reserved.