Tuesday, March 15, 2016

Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 9)

What is a DMF?

Ans- A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

Important facts regarding DMFs

It is submitted to FDA to provide confidential information. Its submission is not required by law or regulations. It is neither approved nor disapproved

It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these. It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420. It is not required when applicant references its own information.

What are the types of DMF’s?


Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA)

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III: Packaging Material

Type IV : Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V: FDA Accepted Reference Information (FDA discourages its use)

What is a Marketing Authorization Application?

Ans- It is an application filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine.

As per UK’s MHRA-

Applications for new active substances are described as 'full applications'.

Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’.

What is an ASMF?

Ans-Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance.

In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical Ingredient (API)”.

.What are the types of active substances for which ASMFs are submitted?


New active substances. Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member StatePharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State.
What is the difference between DMF and ASMF (with respect to submission)?

Ans-ASMF is submitted as Applicant’s Part (Open Part) and Restricted Part (Closed Part)

There isn’t any differentiation of DMF’s into parts

What is meant by 180 day exclusivity?

Ans-The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and thereby runs the risk of having to defend a patent infringement suit.

180 Day Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of  Lipitor ( Atorvastatin calcium).

What is the Full form of abbreviation, CEP?

Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs

It is also informally referred to as Certificate of Suitability (COS)

What is a CEP?

It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.

What is CTD?

Ans-The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.

What is ICH?

Ans-International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration

What are the ICH guidelines to be referred for preparation of registration dossiers/applications of medicines (With respect to format and contents in each module)?


M4   Guideline

M4Q Guideline

M4S Guideline

M4E Guideline

What are the modules in CTD?


The Common Technical Document is divided into five modules:

Module 1. Administrative information and prescribing information

Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5)

Module 3. Quality

Module 4. Nonclinical Study Reports (toxicology studies)

Module 5. Clinical Study Reports (clinical studies)

What is a 505 (b)(2) application ?

Ans- 505 (b)(2) application is a type of NDA for which one or more investigations relied on by applicant for approval were not conducted by/for applicant and for which applicant has not obtained a right of reference.

What kind of application can be submitted as a 505(b)(2) application?


New chemical entity (NCE)/new molecular entity (NME)Changes to previously approved drugs.

What are the examples of changes to approved drug products for which 505(b)(2) application should be submitted ?


Change in dosage form. Change in strength Change in route of administration Substitution of an active ingredient in a formulation product Change in formulation Change in dosing regimen Change in active ingredient New combination Product New indication Change from prescription indication to OTC indication Naturally derived or recombinant active

Name of Company: MNC Pharmaceutical Company
Company Website : Not applicable
Date of interview: 15-01-2016
Interview for the Department: Injectable / Solid / Liquid /Semi solid
Interview for the Post: Regulatory affair Manager
Interview for the Plant: India
Mode of service :  Permanent

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1 comment:

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