PHARMACEUTICAL REGULATORY AFFAIRS

DOCUMENTATION AND REGULATORY WRITING

MAY 2017

SHORT EASSAY 10 MARKS

Q1. Quality cannot be tested into products: quality should be built in by design’.
Justify this statement with relevance to produce development plan (PDP) AND
Product Development Report.
Q2. Explain the contents and organisation of a Dossier. Explain its compilation
and review.
Q3. Differentiate between internal audit, external audit and external third-party
audit. Explain the process of preparation and conducting an audit.
Q4. Explain quality systems requirements for national good manufacturing
inspectorates.
SHORT NOTES

Q1. Write a note on exploratory product development brief(EPDB) for drug

substances and drug Products.
Q2. Explain the contents of Master Formula Records(MFR).
Q3. Write a note on organisation and submission of Common Technical
Documentation (CTD)
Q4. Explain the planning and requirements of electronic dossier submission.
Add a note on Regulatory Bindings.
Q5. Explain Audit analysis, audit report and follow up.
Q6. Explain Good Manufacturing Practices (GMP) compliance Audits.
Q7. Write a note on format and contents of inspection report.
Q8. Write a note on inspection of Pharmaceutical Manufacturers.
Q9. Explain Scale up and post approval changes (SUPAC).
Q10. Write a note on Annual Report.
Q11. Explain the process of Food and Drug Administration (FDA) inspection and
enforcement.
Q12. Write a Note on product life cycle management.
 PHARMACEUTICAL REGULATORY AFFAIRS

GOOD REGULATORY PRACTICES

NOV 2017

LONG ESSAY
Q1. Explain the classification system for in vitro Diagnostic (IVD) Medical
Devices.
Q2. What is Good Laboratory Practice (GLP)? Explain the content of the protocol
and compliance requirements for GLP.
Q3. Describe principles an requirements of Good Automated Laboratory
Practices (GALP)
Q4. Write principles and legal requirements of Good Distribution Practices.

SHORT ESSAY
Q1. WHO current Good Manufacturing (cGMP) Guidelines.
Q2. US cGMP 21 Code of Federal Regulation (CFR) Part 211.
Q3. Goals of Laboratory Audit.
Q4. Audit Tools of GLP.
Q5. General Checklist of 21 CFR Part 11.
Q6. Training Documentation of GALP.
Q7. CDSCO guideline on GDP.
Q8. Salient Features of ISO 13485 Guidelines
Q9. Define Validation and Qualification. Write their types.
Q10. Six Sigma Concept.
Q11. What are ICH Guidelines for establishing Quality, Safety, efficacy of Drug
Substances.
 PHARMACEUTICAL REGULATORY AFFAIRS
DOCUMENTATION AND REGULATORY WRITING,
NOV 2017

I. LONG ESSAY (Answer any THREE questions)

Q1. Explain Product Development Report (PDR). Explain the contents and
importance of PDR.
Q2. What is meant by Dossier? Explain the Components of a Dossiers.
Q3. Describe the Importance and Conduct of Audits.
Q4. Explain how Inspections of Pharmaceutical Manufacturers are Done.

Section B
II. SHORT ESSAY (Answer any NINE questions)
Q5. Drug Master File
Q6. Batch Packaging Records.
Q7. Uses of the FDAs (ESG) Electronic Submission Gateway.
Q8. Electronic Common Technical Documentation (eCTD) Submission.
Q9. Compare Internal, External, second party and Externel third paty Audit.
Q10. Purpose of Audit Follow up.
Q11. Root Cause Analysis of a Deviation.
Q12. Quality System requirements for National Good Manufacturing Practice
Inspectorates.
Q13. Post Marketing Reporting Requirements for a Drug Product.
Q14. Scale up and post approval Changes (SUPAC) for an approved Drug Product.
Q15. Stages for pharmaceutical product lifecycle.
Q16. Establishment Inspection Report. (EIR)
 PHARMACEUTICAL REGULATORY AFFAIRS

GOOD REGULATORY PRACTICES

NOV 2018

LONG ESSAY
Q1. Describe the role of current Good Manufacturing Practices (cGMP) in
regulation of Medical Devices. Add a Note on Global Harmonization Task Force.
(GHTF)
Q2. Discuss how 21CFR Part 58 enforces Good Laboratory Practices(GLP).
Q3. Explain the Scope of Electronic records and Electronic Signatures.
Q4. Elaborate on WHO Good Distribution Practices for Pharmaceutical products.

SHORT ESSAY
Q5. Relationship of cGMP with 21 CFR.
Q6. Records and Reports as per cGMP practices for finished pharmaceuticals.
Q7. Inspections and Audits in GLP.
Q8. What is International Organisation for Standardization (ISO)? / International
Electrotechnical Commission (IEC) 17025
Q9. SOPs of Good Automated Laboratory Practices {GALP}.
Q10. Enumerate the role of ISO and Quality Control of India in enforcing GALP.
Q11. Legal Good Distribution Practices (GDP) World Wide?
Q12. Supply Chain Integration.
Q13. Explain how Change Control is used to control the changes made in the
Pharmaceutical Industry.
Q14. Validation Masterplan.
Q15 ICH guidelines to establish efficacy.
Q16. Role of CDSCO in enforcing QMS in Pharmaceutical Industry.
 PHARMACEUTICAL REGULATORY AFFAIRS
DOCUMENTATION AND REGULATORY WRITING,
NOV 2018
LONG ASSAY
Q1. Describe Site Master File and Drug Master File
Q2. Describe Common Technical Document (CTD) and eCTD explain the NeeS
format.
Q3. What are Audits ? Explain 2 types of Audits.
Q4. Write a noe on ore-approval inspections. Discuss corrective actions and
preventive actions.

SHORT ESSAY.
Q5. Batch manufacturing records and its calculations.
Q6. Distribution Records.
Q7. Compilation and Review of Dossiers,
Q8. Regulatory Bindings for Dossier Submission.
Q9. Audit analysis and preparation of audit report.
Q10. GMP compliance audit process.
Q11. Need for inspection of Drug Distribution channels.
Q12. Model Certificate of Good Manufacturing Practices.
Q13. Post Approval Changes (SUPAC) process for an approved Drug Product.
Q14. FDA inspection and enforcement.
Q15.Product Lifecycle Management.
Q16. Establishment inspection Report and warning Letters.