rgpv syllabus MPharm PCI Grading System 1st Semester Microsoft Word

<<<<<<< HEAD rgpv syllabus MPharm PCI Grading System 1st Semester Microsoft Word - M Pharm PCI Syllabus all branches

PHARMACEUTICAL QUALITY ASSURANCE (MQA)

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES (MQA 101T)

Scope

This subject deals with various advanced analytical instrumental techniques for identification, characterization and quantification of drugs. Instruments dealt are NMR, Mass spectrometer, IR, HPLC, GC etc.

Objectives

After completion of course student is able to know about chemicals and excipients

 The analysis of various drugs in single and combination dosage forms

 Theoretical and practical skills of the instruments

THEORY 60 Hrs

a. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation associated with UV-Visible spectroscopy, Choice of solvents and solvent effect and Applications of UV-Visible spectroscopy, Difference/ Derivative spectroscopy.
1. IR spectroscopy: Theory, Modes of Molecular vibrations, Sample handling, Instrumentation of Dispersive and Fourier - Transform IR Spectrometer, Factors affecting vibrational frequencies and Applications of IR spectroscopy, Data Interpretation.
2. Spectroflourimetry: Theory of Fluorescence, Factors
  affecting fluorescence (Characterestics of drugs that can be analysed by flourimetry), Quenchers, Instrumentation and Applications of fluorescence spectrophotometer.
3. Flame emission spectroscopy and Atomic absorption

spectroscopy: Principle, Instrumentation, Interferences and Applications.

NMR spectroscopy: Quantum numbers and their role in NMR, Principle, Instrumentation, Solvent requirement in NMR, Relaxation process, NMR signals in various compounds, Chemical shift, Factors influencing chemical shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic double resonance, Brief outline of principles of FT-NMR and 13C NMR. Applications of NMR spectroscopy.
12
Hrs

12
Hrs
Mass Spectroscopy: Principle, Theory, Instrumentation of Mass Spectroscopy, Different types of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI Analyzers of Quadrupole and Time of Flight, Mass fragmentation and its rules, Meta stable ions, Isotopic peaks and Applications of Mass spectroscopy.
Chromatography: Principle, apparatus, instrumentation, chromatographic parameters, factors affecting resolution, isolation of drug from excipients, data interpretation and applications of the following:
 Thin Layer chromatography
 High Performance Thin Layer Chromatography
 Ion exchange chromatography
 Column chromatography
 Gas chromatography
 High Performance Liquid chromatography
 Ultra High Performance Liquid chromatography
 Affinity chromatography
 Gel Chromatography
a. Electrophoresis: Principle, Instrumentation, Working conditions, factors affecting separation and applications of the following:
1. Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis d) Zone electrophoresis e) Moving boundary electrophoresis f) Iso electric focusing
  b. X ray Crystallography: Production of X rays, Different X ray
  methods, Bragg‘s law, Rotating crystal technique, X ray powder technique, Types of crystals and applications of X-ray diffraction.
a. Potentiometry: Principle, working, Ion selective Electrodes and Application of potentiometry.

b. Thermal Techniques: Principle, thermal transitions and Instrumentation (Heat flux and power-compensation and designs), Modulated DSC, Hyper DSC, experimental parameters (sample preparation, experimental conditions, calibration, heating and cooling rates, resolution, source of errors) and their influence, advantage and disadvantages, pharmaceutical applications. Differential Thermal Analysis (DTA): Principle, instrumentation

Hrs

and advantage and disadvantages, pharmaceutical applications, derivative differential thermal analysis (DDTA). TGA: Principle, instrumentation, factors affecting results, advantage and disadvantages, pharmaceutical applications.

REFERENCES

Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition, John Wiley & Sons, 2004.
Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th edition, CBS Publishers, New Delhi, 1997.
Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd Edition, CBS Publishers, New Delhi, 1997.
Pharmaceutical Analysis - Modern Methods – Part B - J W Munson, Vol 11, Marcel. Dekker Series
Spectroscopy of Organic Compounds, 2nd edn., P.S/Kalsi, Wiley estern Ltd., Delhi.
Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley & Sons, 1982.
Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley & Sons, 1982.

QUALITY MANAGEMENT SYSTEMS (MQA 102T)

Scope

This course is designed to impart fundamental knowledge and concepts about various quality management principles and systems utilized in the manufacturing industry. It also aids in understanding the quality evaluation in the pharmaceutical industries.

Objectives

At completion of this course it is expected that students will be able to understand-

 The importance of quality

 ISO management systems

 Tools for quality improvement

 Analysis of issues in quality

 Quality evaluation of pharmaceuticals

 Stability testing of drug and drug substances

 Statistical approaches for quality

THEORY 60 Hrs

1. Introduction to Quality: Evolution of Quality, Definition of Quality, Dimensions of Quality

Quality as a Strategic Decision: Meaning of strategy and strategic quality management, mission and vision statements, quality policy, Quality objectives, strategic planning and implementation, McKinsey 7s model, Competitive analysis, Management commitment to quality

Customer Focus: Meaning of customer and customer focus, Classification of customers, Customer focus, Customer perception of quality, Factors affecting customer perception, Customer requirements, Meeting customer needs and expectations, Customer satisfaction and Customer delight, Handling customer complaints, Understanding customer behavior, concept of internal and external customers. Case studies.

Cost of Quality: Cost of quality, Categories of cost of Quality, Models of cost of quality, Optimising costs, Preventing cost of quality.

Hrs

Pharmaceutical quality Management: Basics of Quality Management, Total Quality Management (TQM), Principles of Six sigma, ISO 9001:2008, 9001:2015, ISO 14001:2004,
Pharmaceutical Quality Management – ICH Q10, Knowledge management, Quality Metrics, Operational Excellence and Quality Management Review. OSHAS guidelines, NABL certification and accreditation, CFR-21 part 11, WHO-GMP requirements.
Six System Inspection model: Quality Management system, Production system, Facility and Equipment system, Laboratory control system, Materials system, Packaging and labeling system. Concept of self inspection.
Quality systems: Change Management/ Change control.
Deviations, Out of Specifications (OOS), Out of Trend (OOT), Complaints - evaluation and handling, Investigation and determination of root cause, Corrective & Preventive Actions (CAPA), Returns and Recalls, Vendor Qualification, Annual Product Reviews, Batch Review and Batch Release. Concept of IPQC, area clearance/ Line clearance.
Drug Stability: ICH guidelines for stability testing of drug substances and drug products.
Study of ICH Q8, Quality by Design and Process
development report
Quality risk management: Introduction, risk assessment, risk control, risk review, risk management tools, HACCP, risk ranking and filtering according to ICH Q9 guidelines.
Statistical Process control (SPC): Definition and Importance of SPC, Quality measurement in manufacturing, Statistical control charts - concepts and general aspects, Advantages of statistical control, Process capability, Estimating Inherent or potential capability from a control chart analysis, Measuring process control and quality improvement, Pursuit of decreased process variability.
Regulatory Compliance through Quality Management and development of Quality Culture

Benchmarking: Definition of benchmarking, Reasons for benchmarking, Types of Benchmarking, Benchmarking process, Advantages of benchmarking, Limitations of benchmarking.

Hrs

8 Hrs

4 Hrs

REFERENCES

Implementing Juran's Road Map for Quality Leadership: Benchmarks and Results, By Al Endres, Wiley, 2000
Understanding, Managing and Implementing Quality: Frameworks, Techniques and Cases, By Jiju Antony; David Preece, Routledge, 2002
Organizing for High Performance: Employee Involvement, TQM, Reengineering, and Knowledge Management in the Fortune 1000: The CEO Report By Edward E. Lawler; Susan Albers Mohrman; George Benson, Jossey-Bass, 2001
Corporate Culture and the Quality Organization By James W. Fairfield- Sonn, Quorum Books, 2001
The Quality Management Sourcebook: An International Guide to Materials and Resources By Christine Avery; Diane Zabel, Routledge, 1997
The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ Publications
Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De Feo, ASQ Publications
Root Cause Analysis, The Core of Problem Solving and Corrective Action, Duke Okes, 2009, ASQ Publications.

QUALITY CONTROL AND QUALITY ASSURANCE (MQA 103T)

Scope

This course deals with the various aspects of quality control and quality assurance aspects of pharmaceutical industries. It covers the important aspects like cGMP, QC tests, documentation, quality certifications, GLP and regulatory affairs.

Objectives

Upon completion of this course the student should be able to

 Understand the cGMP aspects in a pharmaceutical industry

 To appreciate the importance of documentation

 To understand the scope of quality certifications applicable to Pharmaceutical industries

 To understand the responsibilities of QA & QC departments.

THEORY 60 Hrs

1. Introduction: Concept and evolution and scopes of Quality Control and Quality Assurance, Good Laboratory Practice, GMP, Overview of ICH Guidelines - QSEM, with special emphasis on Q- series guidelines.

Good Laboratory Practices: Scope of GLP, Definitions, Quality

assurance unit, protocol for conduct of non clinical testing, control on animal house, report preparation and documentation. CPCSEA guidelines.

cGMP guidelines according to schedule M, USFDA (inclusive of CDER and CBER) Pharmaceutical Inspection Convention(PIC), WHO and EMEA covering: Organization and personnel responsibilities, training, hygiene and personal records, drug industry location, design, construction and plant lay out, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination and Good Warehousing Practice.
Analysis of raw materials, finished products, packaging materials, in process quality control (IPQC), Developing specification (ICH Q6 and Q3), purchase specifications and maintenance of stores for raw materials.
12
Hrs

12
Hrs

12
Hrs
In process quality control and finished products quality control for following dosage forms in Pharma industry according to Indian, US and British pharmacopoeias: tablets, capsules, ointments, suppositories, creams, parenterals, ophthalmic and surgical products (How to refer pharmacopoeias).
Documentation in pharmaceutical industry: Three tier documentation, Policy, Procedures and Work instructions, and records (Formats), Basic principles- How to maintain, retention and retrieval etc. Standard operating procedures (How to write), Master Batch Record, Batch Manufacturing Record, Quality audit plan and reports. Specification and test procedures, Protocols and reports. Distribution records. Electronic data handling. Concepts of controlled and uncontrolled documents.
Submission documents for regulators DMFs, as Common Technical Document and Electronic Common Technical Documentation (CTD, eCTD). Concept of regulated and non regulated markets.
Manufacturing operations and controls: Sanitation of manufacturing premises, mix-ups and cross contamination, processing of intermediates and bulk products, packaging operations, IPQC, release of finished product, process deviations, charge-in of components, time limitations on production, drug product inspection, expiry date calculation, calculation of yields, production record review, change control, sterile products, aseptic process control, packaging, reprocessing, salvaging, handling of waste and scrap disposal.
Introduction, scope and importance of intellectual property rights. Concept of trade mark, copyright and patents.
REFERENCES
12
Hrs

12
Hrs
1. Quality Assurance Guide by organization of Pharmaceutical Procedures of India, 3rd revised edition, Volume I & II, Mumbai, 1996.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69, Marcel Dekker Series, 1995.
3. Quality Assurance of Pharmaceuticals- A compedium of Guide lines and Related materials Vol I & II, 2nd edition, WHO Publications, 1999.
4. How to Practice GMP’s – P P Sharma, Vandana Publications, Agra, 1991.
5. The International Pharmacopoeia – vol I, II, III, IV & V - General Methods of Analysis and Quality specification for Pharmaceutical Substances, Excepients and Dosage forms, 3rd edition, WHO, Geneva, 2005.
6. Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38, Marcel
  Dekker Series, 1989.
7. ICH guidelines
8. ISO 9000 and total quality management
9. The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 4th edition, Susmit Publishers, 2006.
10. QA Manual – D.H. Shah, 1st edition, Business Horizons, 2000.
11. Good Manufacturing Practices for Pharmaceuticals a plan for total quality control – Sidney H. Willig, Vol. 52, 3rd edition, Marcel Dekker Series.
12. Steinborn L. GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 1 - With Checklists and Software Package). Taylor & Francis; 2003.
13. Sarker DK. Quality Systems and Controls for Pharmaceuticals. John Wiley
  & Sons; 2008.
14. Packaging of Pharmaceuticals. 15.Schedule M and Schedule N.

PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER (MQA 104T)

Scope

This deal with technology transfer covers the activities associated with Drug Substance, Drug Product and analytical tests and methods, required following candidate drug selection to completion of technology transfer from R&D to the first receiving site and technology transfer related to post-marketing changes in manufacturing places.

Objectives

Upon completion of this course the student should be able to

 To understand the new product development process

 To understand the necessary information to transfer technology from R&D to actual manufacturing by sorting out various information obtained during R&D

 To elucidate necessary information to transfer technology of existing products between various manufacturing places

THEORY 60 Hrs

1. Principles of Drug discovery and development: Introduction, Clinical research process. Development and informational content for Investigational New Drugs Application (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Supplemental New Drug Application (SNDA), Scale Up Post Approval Changes (SUPAC) and Bulk active chemical Post approval changes (BACPAC), Post marketing surveillance, Product registration guidelines – CDSCO, USFDA.

Pre-formulation studies: Introduction/concept, organoleptic properties, purity, impurity profiles, particle size, shape and surface area. Solubility, Methods to improve solubility of Drugs: Surfactants & its importance, co-solvency. Techniques for the study of Crystal properties and polymorphism. Pre-formulation protocol, Stability testing during product development.
Pilot plant scale up: Concept, Significance, design, layout of pilot plant scale up study, operations, large scale manufacturing techniques (formula, equipment, process, stability and quality control) of solids, liquids, semisolid and parenteral dosage forms. New era of drug products: opportunities and challenges.
12
Hrs

12
Hrs

12
Hrs
Pharmaceutical packaging: Pharmaceutical dosage form and their packaging requirments, Pharmaceutical packaging materials, Medical device packaging, Enteral Packaging, Aseptic packaging systems, Container closure systems, Issues facing modern drug packaging, Selection and evaluation of Pharmaceutical packaging materials.
Quality control test: Containers, closures and secondary packing materials.
Technology transfer: Development of technology by R & D,
Technology transfer from R & D to production, Optimization and Production, Qualitative and quantitative technology models.
Documentation in technology transfer: Development report, technology transfer plan and Exhibit.
12
Hrs

12
Hrs

REFERENCES
1. The process of new drug discovery and development. I and II Edition (2006) by Charles G. Smith, James T and O. Donnell. CRC Press, Group of Taylor and Francis.
2. Leon Lac Lachman, Herbert A. Liberman, Theory and Practice of Industrial
  Pharmacy. Marcel Dekker Inc. New York.
3. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good manufacturing of pharmaceuticals (A Plan for total quality control) 3rd Edition. Bhalani publishing house Mumbai.
4. Tablets Vol. I, II, III by Leon Lachman, Herbert A. Liberman, Joseph B. Schwartz, 2nd Edn. (1989) Marcel Dekker Inc. New York.
5. Text book of Bio- Pharmaceutics and clinical Pharmacokinetics by Milo Gibaldi, 3rd Edn, Lea & Febriger, Philadelphia.
6. Pharmaceutical product development. Vandana V. Patrevale. John I. Disouza. Maharukh T.Rustomji. CRC Press, Group of Taylor and Francis.
7. Dissolution, Bioavailability and Bio-Equivalence by Abdou H.M, Mack Publishing company, Eastern Pennsylvania.
8. Remingtons Pharmaceutical Sciences, by Alfonso & Gennaro, 19th Edn.(1995)OO2C Lippincott; Williams and Wilkins A Wolters Kluwer Company, Philadelphia.
9. The Pharmaceutical Sciences; the Pharma Path way ‘Pure and applied Pharmacy’ by D. A Sawant, Pragathi Books Pvt. Ltd.
10. Pharmaceutical Packaging technology by D.A. Dean. E.R. Evans, I.H. Hall.

1st Edition(Reprint 2006). Taylor and Francis. London and New York.

QUALITY ASSURANCE PRACTICAL - I (MQA 105P)

PRACTICALS

Analysis of Pharmacopoeial compounds in bulk and in their formulations (tablet/ capsules/ semisolids) by UV Vis spectrophotometer
Simultaneous estimation of multi-drug component containing formulations by UV spectrophotometry
Experiments based on HPLC
Experiments based on Gas Chromatography
Estimation of riboflavin/quinine sulphate by fluorimetry
Estimation of sodium/potassium by flame photometry or AAS
Case studies on
 Total Quality Management
 Six Sigma
 Change Management/ Change control. Deviations,
 Out of Specifications (OOS)
 Out of Trend (OOT)
 Corrective & Preventive Actions (CAPA)
 Deviations
Development of Stability study protocol
Estimation of process capability
In process and finished product quality control tests for tablets, capsules, parenterals and semisolid dosage forms.
Assay of raw materials as per official monographs
Testing of related and foreign substances in drugs and raw materials
To carry out pre formulation study for tablets, parenterals (2 experiment).
To study the effect of pH on the solubility of drugs, (1 experiment)
Quality control tests for Primary and secondary packaging materials
Accelerated stability studies (1 experiment)
Improved solubility of drugs using surfactant systems (1 experiment)
Improved solubility of drugs using co-solvency method (1 experiment)
Determination of Pka and Log p of drugs.

======= rgpv syllabus MPharm PCI Grading System 1st Semester Microsoft Word - M Pharm PCI Syllabus all branches

PHARMACEUTICAL QUALITY ASSURANCE (MQA)

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES (MQA 101T)

Scope

Objectives

After completion of course student is able to know about chemicals and excipients

 The analysis of various drugs in single and combination dosage forms

 Theoretical and practical skills of the instruments

THEORY 60 Hrs

a. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation associated with UV-Visible spectroscopy, Choice of solvents and solvent effect and Applications of UV-Visible spectroscopy, Difference/ Derivative spectroscopy.
1. IR spectroscopy: Theory, Modes of Molecular vibrations, Sample handling, Instrumentation of Dispersive and Fourier - Transform IR Spectrometer, Factors affecting vibrational frequencies and Applications of IR spectroscopy, Data Interpretation.
2. Spectroflourimetry: Theory of Fluorescence, Factors
  affecting fluorescence (Characterestics of drugs that can be analysed by flourimetry), Quenchers, Instrumentation and Applications of fluorescence spectrophotometer.
3. Flame emission spectroscopy and Atomic absorption

spectroscopy: Principle, Instrumentation, Interferences and Applications.

NMR spectroscopy: Quantum numbers and their role in NMR, Principle, Instrumentation, Solvent requirement in NMR, Relaxation process, NMR signals in various compounds, Chemical shift, Factors influencing chemical shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic double resonance, Brief outline of principles of FT-NMR and 13C NMR. Applications of NMR spectroscopy.
12
Hrs

12
Hrs
Mass Spectroscopy: Principle, Theory, Instrumentation of Mass Spectroscopy, Different types of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI Analyzers of Quadrupole and Time of Flight, Mass fragmentation and its rules, Meta stable ions, Isotopic peaks and Applications of Mass spectroscopy.
Chromatography: Principle, apparatus, instrumentation, chromatographic parameters, factors affecting resolution, isolation of drug from excipients, data interpretation and applications of the following:
 Thin Layer chromatography
 High Performance Thin Layer Chromatography
 Ion exchange chromatography
 Column chromatography
 Gas chromatography
 High Performance Liquid chromatography
 Ultra High Performance Liquid chromatography
 Affinity chromatography
 Gel Chromatography
a. Electrophoresis: Principle, Instrumentation, Working conditions, factors affecting separation and applications of the following:
1. Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis d) Zone electrophoresis e) Moving boundary electrophoresis f) Iso electric focusing
  b. X ray Crystallography: Production of X rays, Different X ray
  methods, Bragg‘s law, Rotating crystal technique, X ray powder technique, Types of crystals and applications of X-ray diffraction.
a. Potentiometry: Principle, working, Ion selective Electrodes and Application of potentiometry.

Hrs

REFERENCES

Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition, John Wiley & Sons, 2004.
Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th edition, CBS Publishers, New Delhi, 1997.
Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd Edition, CBS Publishers, New Delhi, 1997.
Pharmaceutical Analysis - Modern Methods – Part B - J W Munson, Vol 11, Marcel. Dekker Series
Spectroscopy of Organic Compounds, 2nd edn., P.S/Kalsi, Wiley estern Ltd., Delhi.
Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley & Sons, 1982.
Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley & Sons, 1982.

QUALITY MANAGEMENT SYSTEMS (MQA 102T)

Scope

Objectives

At completion of this course it is expected that students will be able to understand-

 The importance of quality

 ISO management systems

 Tools for quality improvement

 Analysis of issues in quality

 Quality evaluation of pharmaceuticals

 Stability testing of drug and drug substances

 Statistical approaches for quality

THEORY 60 Hrs

1. Introduction to Quality: Evolution of Quality, Definition of Quality, Dimensions of Quality

Cost of Quality: Cost of quality, Categories of cost of Quality, Models of cost of quality, Optimising costs, Preventing cost of quality.

Hrs

Pharmaceutical quality Management: Basics of Quality Management, Total Quality Management (TQM), Principles of Six sigma, ISO 9001:2008, 9001:2015, ISO 14001:2004,
Pharmaceutical Quality Management – ICH Q10, Knowledge management, Quality Metrics, Operational Excellence and Quality Management Review. OSHAS guidelines, NABL certification and accreditation, CFR-21 part 11, WHO-GMP requirements.
Six System Inspection model: Quality Management system, Production system, Facility and Equipment system, Laboratory control system, Materials system, Packaging and labeling system. Concept of self inspection.
Quality systems: Change Management/ Change control.
Deviations, Out of Specifications (OOS), Out of Trend (OOT), Complaints - evaluation and handling, Investigation and determination of root cause, Corrective & Preventive Actions (CAPA), Returns and Recalls, Vendor Qualification, Annual Product Reviews, Batch Review and Batch Release. Concept of IPQC, area clearance/ Line clearance.
Drug Stability: ICH guidelines for stability testing of drug substances and drug products.
Study of ICH Q8, Quality by Design and Process
development report
Quality risk management: Introduction, risk assessment, risk control, risk review, risk management tools, HACCP, risk ranking and filtering according to ICH Q9 guidelines.
Statistical Process control (SPC): Definition and Importance of SPC, Quality measurement in manufacturing, Statistical control charts - concepts and general aspects, Advantages of statistical control, Process capability, Estimating Inherent or potential capability from a control chart analysis, Measuring process control and quality improvement, Pursuit of decreased process variability.
Regulatory Compliance through Quality Management and development of Quality Culture

Benchmarking: Definition of benchmarking, Reasons for benchmarking, Types of Benchmarking, Benchmarking process, Advantages of benchmarking, Limitations of benchmarking.

Hrs

8 Hrs

4 Hrs

REFERENCES

Implementing Juran's Road Map for Quality Leadership: Benchmarks and Results, By Al Endres, Wiley, 2000
Understanding, Managing and Implementing Quality: Frameworks, Techniques and Cases, By Jiju Antony; David Preece, Routledge, 2002
Organizing for High Performance: Employee Involvement, TQM, Reengineering, and Knowledge Management in the Fortune 1000: The CEO Report By Edward E. Lawler; Susan Albers Mohrman; George Benson, Jossey-Bass, 2001
Corporate Culture and the Quality Organization By James W. Fairfield- Sonn, Quorum Books, 2001
The Quality Management Sourcebook: An International Guide to Materials and Resources By Christine Avery; Diane Zabel, Routledge, 1997
The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ Publications
Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De Feo, ASQ Publications
Root Cause Analysis, The Core of Problem Solving and Corrective Action, Duke Okes, 2009, ASQ Publications.

QUALITY CONTROL AND QUALITY ASSURANCE (MQA 103T)

Scope

Objectives

Upon completion of this course the student should be able to

 Understand the cGMP aspects in a pharmaceutical industry

 To appreciate the importance of documentation

 To understand the scope of quality certifications applicable to Pharmaceutical industries

 To understand the responsibilities of QA & QC departments.

THEORY 60 Hrs

Good Laboratory Practices: Scope of GLP, Definitions, Quality

assurance unit, protocol for conduct of non clinical testing, control on animal house, report preparation and documentation. CPCSEA guidelines.

cGMP guidelines according to schedule M, USFDA (inclusive of CDER and CBER) Pharmaceutical Inspection Convention(PIC), WHO and EMEA covering: Organization and personnel responsibilities, training, hygiene and personal records, drug industry location, design, construction and plant lay out, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination and Good Warehousing Practice.
Analysis of raw materials, finished products, packaging materials, in process quality control (IPQC), Developing specification (ICH Q6 and Q3), purchase specifications and maintenance of stores for raw materials.
12
Hrs

12
Hrs

12
Hrs
In process quality control and finished products quality control for following dosage forms in Pharma industry according to Indian, US and British pharmacopoeias: tablets, capsules, ointments, suppositories, creams, parenterals, ophthalmic and surgical products (How to refer pharmacopoeias).
Documentation in pharmaceutical industry: Three tier documentation, Policy, Procedures and Work instructions, and records (Formats), Basic principles- How to maintain, retention and retrieval etc. Standard operating procedures (How to write), Master Batch Record, Batch Manufacturing Record, Quality audit plan and reports. Specification and test procedures, Protocols and reports. Distribution records. Electronic data handling. Concepts of controlled and uncontrolled documents.
Submission documents for regulators DMFs, as Common Technical Document and Electronic Common Technical Documentation (CTD, eCTD). Concept of regulated and non regulated markets.
Manufacturing operations and controls: Sanitation of manufacturing premises, mix-ups and cross contamination, processing of intermediates and bulk products, packaging operations, IPQC, release of finished product, process deviations, charge-in of components, time limitations on production, drug product inspection, expiry date calculation, calculation of yields, production record review, change control, sterile products, aseptic process control, packaging, reprocessing, salvaging, handling of waste and scrap disposal.
Introduction, scope and importance of intellectual property rights. Concept of trade mark, copyright and patents.
REFERENCES
12
Hrs

12
Hrs
1. Quality Assurance Guide by organization of Pharmaceutical Procedures of India, 3rd revised edition, Volume I & II, Mumbai, 1996.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69, Marcel Dekker Series, 1995.
3. Quality Assurance of Pharmaceuticals- A compedium of Guide lines and Related materials Vol I & II, 2nd edition, WHO Publications, 1999.
4. How to Practice GMP’s – P P Sharma, Vandana Publications, Agra, 1991.
5. The International Pharmacopoeia – vol I, II, III, IV & V - General Methods of Analysis and Quality specification for Pharmaceutical Substances, Excepients and Dosage forms, 3rd edition, WHO, Geneva, 2005.
6. Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38, Marcel
  Dekker Series, 1989.
7. ICH guidelines
8. ISO 9000 and total quality management
9. The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 4th edition, Susmit Publishers, 2006.
10. QA Manual – D.H. Shah, 1st edition, Business Horizons, 2000.
11. Good Manufacturing Practices for Pharmaceuticals a plan for total quality control – Sidney H. Willig, Vol. 52, 3rd edition, Marcel Dekker Series.
12. Steinborn L. GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 1 - With Checklists and Software Package). Taylor & Francis; 2003.
13. Sarker DK. Quality Systems and Controls for Pharmaceuticals. John Wiley
  & Sons; 2008.
14. Packaging of Pharmaceuticals. 15.Schedule M and Schedule N.

PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER (MQA 104T)

Scope

Objectives

Upon completion of this course the student should be able to

 To understand the new product development process

 To understand the necessary information to transfer technology from R&D to actual manufacturing by sorting out various information obtained during R&D

 To elucidate necessary information to transfer technology of existing products between various manufacturing places

THEORY 60 Hrs

Pre-formulation studies: Introduction/concept, organoleptic properties, purity, impurity profiles, particle size, shape and surface area. Solubility, Methods to improve solubility of Drugs: Surfactants & its importance, co-solvency. Techniques for the study of Crystal properties and polymorphism. Pre-formulation protocol, Stability testing during product development.
Pilot plant scale up: Concept, Significance, design, layout of pilot plant scale up study, operations, large scale manufacturing techniques (formula, equipment, process, stability and quality control) of solids, liquids, semisolid and parenteral dosage forms. New era of drug products: opportunities and challenges.
12
Hrs

12
Hrs

12
Hrs
Pharmaceutical packaging: Pharmaceutical dosage form and their packaging requirments, Pharmaceutical packaging materials, Medical device packaging, Enteral Packaging, Aseptic packaging systems, Container closure systems, Issues facing modern drug packaging, Selection and evaluation of Pharmaceutical packaging materials.
Quality control test: Containers, closures and secondary packing materials.
Technology transfer: Development of technology by R & D,
Technology transfer from R & D to production, Optimization and Production, Qualitative and quantitative technology models.
Documentation in technology transfer: Development report, technology transfer plan and Exhibit.
12
Hrs

12
Hrs

REFERENCES
1. The process of new drug discovery and development. I and II Edition (2006) by Charles G. Smith, James T and O. Donnell. CRC Press, Group of Taylor and Francis.
2. Leon Lac Lachman, Herbert A. Liberman, Theory and Practice of Industrial
  Pharmacy. Marcel Dekker Inc. New York.
3. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good manufacturing of pharmaceuticals (A Plan for total quality control) 3rd Edition. Bhalani publishing house Mumbai.
4. Tablets Vol. I, II, III by Leon Lachman, Herbert A. Liberman, Joseph B. Schwartz, 2nd Edn. (1989) Marcel Dekker Inc. New York.
5. Text book of Bio- Pharmaceutics and clinical Pharmacokinetics by Milo Gibaldi, 3rd Edn, Lea & Febriger, Philadelphia.
6. Pharmaceutical product development. Vandana V. Patrevale. John I. Disouza. Maharukh T.Rustomji. CRC Press, Group of Taylor and Francis.
7. Dissolution, Bioavailability and Bio-Equivalence by Abdou H.M, Mack Publishing company, Eastern Pennsylvania.
8. Remingtons Pharmaceutical Sciences, by Alfonso & Gennaro, 19th Edn.(1995)OO2C Lippincott; Williams and Wilkins A Wolters Kluwer Company, Philadelphia.
9. The Pharmaceutical Sciences; the Pharma Path way ‘Pure and applied Pharmacy’ by D. A Sawant, Pragathi Books Pvt. Ltd.
10. Pharmaceutical Packaging technology by D.A. Dean. E.R. Evans, I.H. Hall.

1st Edition(Reprint 2006). Taylor and Francis. London and New York.

QUALITY ASSURANCE PRACTICAL - I (MQA 105P)

PRACTICALS

Analysis of Pharmacopoeial compounds in bulk and in their formulations (tablet/ capsules/ semisolids) by UV Vis spectrophotometer
Simultaneous estimation of multi-drug component containing formulations by UV spectrophotometry
Experiments based on HPLC
Experiments based on Gas Chromatography
Estimation of riboflavin/quinine sulphate by fluorimetry
Estimation of sodium/potassium by flame photometry or AAS
Case studies on
 Total Quality Management
 Six Sigma
 Change Management/ Change control. Deviations,
 Out of Specifications (OOS)
 Out of Trend (OOT)
 Corrective & Preventive Actions (CAPA)
 Deviations
Development of Stability study protocol
Estimation of process capability
In process and finished product quality control tests for tablets, capsules, parenterals and semisolid dosage forms.
Assay of raw materials as per official monographs
Testing of related and foreign substances in drugs and raw materials
To carry out pre formulation study for tablets, parenterals (2 experiment).
To study the effect of pH on the solubility of drugs, (1 experiment)
Quality control tests for Primary and secondary packaging materials
Accelerated stability studies (1 experiment)
Improved solubility of drugs using surfactant systems (1 experiment)
Improved solubility of drugs using co-solvency method (1 experiment)
Determination of Pka and Log p of drugs.

>>>>>>> html