PB4104 Drug regulatory affairs Syllabus:

PB4104 Drug regulatory affairs Syllabus – Anna University PG Syllabus Regulation 2021

COURSE OBJECTIVES:

The course aims to,
 Enable the students to learn about the drug regulatory laws and the agencies in India and at International level.
 Acquire knowledge of quality drug standards and drug development approval processes
 Attain the knowledge of product safety management.

UNIT I INTRODUCTION TO DRUG REGULATORY LAWS

History, Organization and functions of USFDA, EMEA, Australia TGA, U.K. MHRA, WHO, ICH and ISO. Indian drug regulatory authorities, Central and State regulatory bodies. Need for pharmaceutical regulations- Drugs and Cosmetics Act and Rules 1940 with latest Amendments, Special emphasis – Schedule M and Y. The Drugs (Price Control) Order 2013 with its amendments, The drugs and Magic Remedies (Objectionable advertisements) Act 1954,Guidelinesforevaluationofnanopharmaceuticals in India.

UNIT II PHARMACOPOEIA

Purpose of Pharmacopoeias- Descriptions & Monographs; Standards and Specifications; Testing of Drugs ;Various Countries Pharmacopoeias; Indian, British,U.S, European, Japanese and International pharmacopoeia.

UNIT III cGMPs & REGULATORY RECORDS

cGMP concepts – Introduction, US cGMP Part 210 and Part 211.EC Principles of GMP (Directive 91/356/EEC) Article 6 to Article 14 and WHO cGMP guidelines GAMP-5; Medical device and IVDs Global Harmonization Task Force(GHTF) Guidance docs. Introduction, Organizational Structure, Purpose and Functions, Regulatory Guidelines, Working Groups, Summary Technical Document (STED), Global Medical Device Nomenclature (GMDN).Drug dossier contents-CTD(CMC section) & data. cGMP& ICH guidelines for Accelerated stability Testing.

UNIT IV DRUG DEVELOPMENT APPROVAL PROCESS/CLINICAL TRIALS

Drug development stages, FDA guidelines on IND,NDA,ANDA approvals. European regulatory agency: types of filing process (Centralized, decentralized, RMS countries), Regulation of preclinical studies, Schedule-Y, Introduction to animal ethics; Animal rights and use of animals in the advancement of medical technology; Introduction to laws and regulations regarding the use of animals in research. Good Clinical Practice (ICHGCP) guidelines, History and Idea behind GLP, Areas of Application of GLP, GMP compliance audit

UNIT V QUALITY MANAGEMENT SYSTEMS

Introduction to GDP, data management and integrity, Concept of Quality, Total Quality Management, Quality by design, Six Sigma concept, Out of Specifications (OOS), Change control. Validation: Types of Validation, Types of Qualification, Validation master plan (VMP), Analytical Method Validation. Validation of utilities, [Compressed air, steam, water systems, Heat Ventilation and Air conditioning (HVAC)] and Cleaning Validation. The International Conference on Harmonization (ICH) process, ICH guidelines to establish quality, safety and efficacy of drug substances and products, ISO 13485, Sch MIII and other relevant CDSCO regulatory guidance documents.

TOTAL:45PERIODS

COURSE OUTCOMES:

At the end of the course the students will be able to,
 Apply the knowledge of drug regulatory laws.
 Acquire the knowledge of pharmacopoeia standards.
 Know the quality guidelines and the drug regulating authorities in different countries.
 Have an insight about drug regulatory approval process and clinical trials in pharmaceutical industry.
 Assure the learning of product safety management concepts in pharmaceutical industry.
 Acquire the knowledge of drug regulatory, quality and safety management in pharmaceutical industry

REFERENCES:

1. NU dupaand Krishnamurthy Bhat. A Concise Textbook of Drug Regulatory Affairs , Manipal Univers ityPress,Edition:1, 2015.
2. David M.Bleisner, Establishing a cGMP Laboratory Audit System, A practical Guide, Wiley Publication, 2006.
3. Abraham, John and Smith, H.W. “Regulation of the Pharmaceutical Industry”, Palgrave,Macmillan,2003.
4. Weinberg, Sandy “Good Laboratory Practice Regulations” 4thEdition,Marcel Dekker,2007.
5. Gad, Shayne C.“ Drug Safety Evaluation”,Wiley-Interscience, 3rdEdition,2016.
6. Good Clinical, Laboratory and Manufacturing Practices Techniques for the QA Professional, Edited by PA Carson, and N Dent,, The Royal Society of Chemistry 2007, Published by The Royal Society of Chemistry, Thomas Graham House, Science Park, Milton Road, Cambridge CB4 0WF, UK
7. Laboratory Auditing for Quality and Regulatory compliance bu Donald C. Singer, Drugs and the Pharmaceutical Sciences, Vol.150. 2005.
8. Berry,IraR.andHarpaz,Daniel“ValidationofActivePharmaceuticalIngredients”,2ndEdition, CRCPress, 2001
9. BritishPharmacopoeia,Andesite Press, 2021.
10. United States Pharmacopoeia,2020
11. https://cdsco.gov.in/opencms/opencms/en/Home/
12.https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-goodmanufacturing-practice-cgmp-regulations