Mostly asked 10+ General Pharmaceutical Interview Questions and Answers for 2021-2022
Most commonly asked general questions and answers for the freshers in the pharmaceutical industry. Even though freshers have good knowledge about subjects, following are few general questions which interviewer will expect that candidate must have to know about as it is very basic knowledge and connecting bridge between student life and industry life.
1. What is the Good Manufacturing Practice (GMP) or Current Good Manufacturing Practice (CGMP)? Provide reference to GMP regulations of different countries.
Quality of pharmaceuticals is important for the patient’s safety and are very carefully regulated by respective country regulators.
GMP or CGMP refers to the Current Good Manufacturing Practice regulations enforced by the respective country regulations.
GMP provides systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the GMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
The US FDA uses terminology CGMP. According to the U.S. FDA, “‘C’ in CGMP stands for “current,” requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been “top-of-the-line” to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today’s standards.”
GMP regulations governed by different countries and its reference guidance are detailed as follows. Following table provides reference for most common regulatory bodies. This will provide understanding on how GMP regulations are forced by different regulatory bodies.
|Country||Regulatory Body||Reference regulations under respective country’s law|
|United States||U.S. FDA||Code of Federal Regulations (CFR): |
21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.
21 CFR Part 212. Current Good Manufacturing Practice for Positron Emission Tomography Drugs.
21 CFR Part 600. Biological Products: General.
21 CFR Part 314. For FDA approval to market a new drug.
|European Union (EU) Countries||European Commission – Health and Food Safety||The entire body of EU medicines legislation (EudraLex) is compiled in “The rules governing medicinal products in the European Union”. Pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication “The rules governing medicinal products in the European Union”: |
Volume 1 – EU pharmaceutical legislation for medicinal products for human use
Volume 5 – EU pharmaceutical legislation for medicinal products for veterinary use
|Countries following WHO guidance||World Health Organization (WHO)||WHO good manufacturing practices for pharmaceutical products: main principles, Annex 2, WHO Technical Report Series 986, 2014|
|India||Ministry of health and family welfare||The drugs and cosmetics act, 1940 and The drugs and cosmetics rules, 1945 |
Schedule M: Good Manufacturing Practices and requirements of premises, plant and equipment for pharmaceutical products
|Canada||Health Canada||Good Manufacturing Practices Guidelines by Health Products and Food Branch Inspectorate |
Good Manufacturing Practices (GMP) refer to Division 2, Part C of the Food and Drug Regulations.
The guidelines apply to pharmaceutical, radiopharmaceutical, biological, and veterinary drugs and were developed by Health Canada in consultation with their stakeholders.
Division 1A, Part C of the Food and Drug Regulations defines activities for which GMP compliance is to be demonstrated prior to the issuance of an establishment license. Guidance based on PIC/S
|Japan||Pharmaceuticals and Medical Devices Agency (PMDA)||Pharmaceuticals and Medical Devices Agency (PMDA) was established and came into service on April 1, 2004, under the Law for the Pharmaceuticals and Medical Devices Agency, as a consolidation of the services of the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR/KIKO), and part of the Japan Association for the Advancement of Medical Equipment (JAAME). GMP Ministerial Ordinance (Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs) No. 179, 2004|
|Australia||Therapeutic Goods Administration||AUSTRALIAN CODE OF GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS Therapeutic Goods Act 1989. This upholds the main objective of the Act, which is to ensure the safety, quality, efficacy and timely supply of therapeutic goods for Australian consumers. Guidance based on PIC/S|
|New Zealand||Medsafe||New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods Part 1: Manufacture of Pharmaceutical Products (2009) Guidance based on PIC/S|
2. What is Standard Operating Procedure (SOP)?
SOPs are documented Standards Operating Procedure, authorized by the Quality Unit or Quality Assurance department having sets of written instructions to be followed by employees on a day to day basis to carry out operations in a consistent manner to achieve predetermined specification and a quality end-result.
Examples of Standard Operating Procedures are as follows:
– SOP for entry and exit in the manufacturing facility
– SOP for operation and cleaning of compression machine
– SOP for preparation of SOP
– SOP for pest control
– SOP for material receipt
– SOP for preventive maintenance program
– SOP for operation of High Performance Liquid Chromatography (HPLC) instrument
3. What is the typical content of Standard Operating Procedure (SOP)?
Objective or Purpose
List of Annexes
Format for recording Revision history
4. What is Master Formula Record, Master Formula, Manufacturing Formula, and Master Production and Control Record?
Master Formula Record, Master Formula, Manufacturing Formula, and Master Production and Control Record mean the same thing. This is an approved master document that describes the full manufacturing process of the drug product. [Reference: 1]
5. What is drug substance?
Drug substance is an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient. [Reference: 2]
6. What is drug product?
Drug product means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. [Reference:3]
7. What is Active ingredient?
Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. [Reference:3]
8. Fiber means?
Fiber means any particulate contaminant with a length at least three times greater than its width. [Reference:3]
9. What is inactive ingredient?
Inactive ingredient means any component other than an active ingredient. [Reference:3]
10. What is Gang-printing?
Gang-printed labeling means labeling derived from a sheet of material on which more than one item of labeling is printed. [Reference:3]
11. What is full form of ICH?
Full form of ICH is International Council for Harmonisation (ICH), formerly known as the International Conference on Harmonisation (ICH).
12. ICH Guidelines are divided into how many categories? What are those?
The ICH topics are divided into the four categories below.
13. How many main topic quality guidelines are published by ICH ?
Q1A – Q1F Stability
Q1A(R2) Stability Testing of New Drug Substances and Products
Q1B Stability Testing : Photostability Testing of New Drug Substances and Products
Q1C Stability Testing for New Dosage Forms
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Q1E Evaluation of Stability Data
Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV
Q2 Analytical Validation
Q2(R1) Validation of Analytical Procedures: Text and Methodology
Q2(R2)/Q14 EWG Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation
Q3A – Q3E Impurities
Q3A(R2) Impurities in New Drug Substances
Q3B(R2) Impurities in New Drug Products
Q3C(R8) Guideline for Residual Solvents
Q3C(R9) Maintenance EWG Maintenance of the Guideline for Residual Solvents
Q3D(R1) Guideline for Elemental Impurities
Q3D(R2) Maintenance EWG Revision of Q3D(R1) for cutaneous and transdermal products
Q3D training Implementation of Guideline for Elemental Impurities
Q3E EWG Impurity: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics
Q4A – Q4B Pharmacopoeias
Q4A Pharmacopoeial Harmonisation
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Q4B Annex 1(R1) Residue on Ignition/Sulphated Ash General Chapter
Q4B Annex 2(R1) Test for Extractable Volume of Parenteral Preparations General Chapter
Q4B Annex 3(R1) Test for Particulate Contamination: Sub-Visible Particles General Chapter
Q4B Annex 4A(R1) Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
Q4B Annex 4B(R1) Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter
4C(R1) Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
Q4B Annex 5(R1) Disintegration Test General Chapter
Q4B Annex 6 Uniformity of Dosage Units General Chapter
Q4B Annex 7(R2) Dissolution Test General Chapter
Q4B Annex 8(R1) Sterility Test General Chapter
Q4B Annex 9(R1) Tablet Friability General Chapter
Q4B Annex 10(R1) Polyacrylamide Gel Electrophoresis General Chapter
Q4B Annex 11 Capillary Electrophoresis General Chapter
Q4B Annex 12 Analytical Sieving General Chapter
Q4B Annex 13 Bulk Density and Tapped Density of Powders General Chapter
Q4B Annex 14 Bacterial Endotoxins Test General Chapter
Q4B FAQs Frequently Asked Question
Q5A – Q5E Quality of Biotechnological Products
Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Q5A(R2) EWG Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Q5B Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
Q6A- Q6B Specifications
Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Q7 Good Manufacturing Practice
Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Q7 Q&As Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Q8 Pharmaceutical Development
Q8(R2) Pharmaceutical Development
Q8/9/10 Q&As (R4) Q8/Q9/Q10 – Implementation
Q9 Quality Risk Management
Q9 Quality Risk Management
Q9(R1) EWG Quality Risk Management
Q8/9/10 Q&As (R4) Q8/Q9/Q10 – Implementation
Q10 Pharmaceutical Quality System
Q10 Pharmaceutical Quality System
Q8/9/10 Q&As (R4) Q8/Q9/Q10 – Implementation
Q11 Development and Manufacture of Drug Substances
Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
Q11 Q&As Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances
Q12 Lifecycle Management
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Q12 IWG Training on Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management
Q13 Continuous Manufacturing of Drug Substances and Drug Products
Q13 EWG Continuous Manufacturing of Drug Substances and Drug Products
Q14 Analytical Procedure Development Q2(R2)/Q14 EWG Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation
1. WHO GMP Guidelines: Guide to Master Formulae, WHO/FWC/IVB/QSS/VQR, 2011
EU and PIC GMP guidelines: EudraLex Volume 4, Chapter 4: Documentation
PIC/S guidelines: Chapter 4: Documentation
Health Canada GMP guidelines: Good manufacturing practices guide for drug products (GUI-0001), Manufacturing control, C.02.011
U.S. FDA: CFR 21, Chapter I, Subchapter F: Biologics, Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals; Subpart F–Production and Process Controls, Sec. 211.100 Written procedures; deviations; and Subpart J–Records and Reports; Sec. 211.186 Master production and control records
U.S. FDA: CFR 21, Chapter I, Subchapter F: Biologics; Subchapter C: Drugs General; Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals; Subpart J– Records and Reports; Sec. 211.188 Batch production and control records.
India: The drugs and cosmetics act, 1940 and The drugs and cosmetics rules, 1945, Schedule M, 12. Documentation and records]
2. PART 314 — APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG, Subpart A – General Provisions Sec. 314.3 Definitions.
3. 21 CFR PART 210: CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL Sec. 210.1 Status of current good manufacturing practice regulations.
5. Wet Granulation:
End-Point Determination and Scale-Up, By Michael Levin, Ph. D., Metropolitan Computing Corporation East Hanover, New Jersey, USA
6. Saudi Pharmaceutical Journal
Volume 20, Issue 1, January 2012, Pages 9-19, Saudi Pharmaceutical Journal, Review article, Upgrading wet granulation monitoring from hand squeeze test to mixing torque rheometry Author links open overlay panel Walid F. Sakr Mohamed A. Ibrahim Fars K. Alanazi Adel A. Sakr