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Quality Assurence Syallbus

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49 views23 pages

Quality Assurence Syallbus

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© © All Rights Reserved
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PRACTICAL (MPL205P):

1. Comparison of absorption spectra by UV and Wood ward – Fiesure rule


2. Interpretation of organic compounds by FT-IR
3. Interpretation of organic compounds by NMR
4. Interpretation of organic compounds by MS
5. Determination of purity by DSC in pharmaceuticals
6. Identification of organic compounds using FT-IR, NMR, CNMR and Mass spectra
7. Bio molecules separation utilizing various sample preparation techniques and
Quantitative analysis of components by gel electrophoresis.
8. Bio molecules separation utilizing various sample preparation techniques and
Quantitative analysis of components by HPLC techniques.
9. Isolation of analgesics from biological fluids (Blood serum and urine).
10. Protocol preparation and performance of analytical/Bioanalytical method validation.
11. Protocol preparation for the conduct of BA/BE studies according to guidelines.
12.In process and finished product quality control tests for tablets, capsules, parenterals
and creams
13. Quality control tests for Primary and secondary packing materials
14. Assay of raw materials as per official monographs
15. Testing of related and foreign substances in drugs and raw materials
17. Preparation of Master Formula Record.
18. Preparation of Batch Manufacturing Record.
19. Quantitative analysis of rancidity in lipsticks and hair oil
20. Determination of aryl amine content and Developer in hair dye
21. Determination of foam height and SLS content of Shampoo.
22. Determination of total fatty matter in creams (Soap, skin and hair creams)
23. Determination of acid value and saponification value.
24. Determination of calcium thioglycolate in depilatories

180
M. PHARM. PHARMACEUTICAL QUALITY
ASSURANCE (MQA)

181
MODERN PHARMACEUTICAL ANALYSIS (MPA101T)

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
HOURS

1. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation associated 14 Hrs


with UV-Visible spectroscopy, Choice of solvents and solvent effect and
Applications of UV-Visible spectroscopy, Difference/ Derivative spectroscopy.
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.
Spectroflourimetry: Theory of Fluorescence, Factors affecting fluorescence
(Characterestics of drugs that can be analysed by flourimetry), Quenchers,
Instrumentation and Applications of fluorescence spectrophotometer.
Flame emission spectroscopy and Atomic absorption spectroscopy: Principle,
Instrumentation, Interferences and Applications.

2 NMR spectroscopy: Quantum numbers and their role in NMR, Principle, 10 Hrs
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.

3 Mass Spectroscopy: Principle, Theory, Instrumentation of Mass Spectroscopy, 10 Hrs


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

182
4 Chromatography: Principle, apparatus, instrumentation, chromatographic 12 Hrs
parameters, factors affecting resolution, isolation of drug from excipients, data
interpretation and applications of the following:
a) Thin Layer chromatography
b) High Performance Thin Layer Chromatography
c) Ion exchange chromatography
d) Column chromatography
e) Gas chromatography
f) High Performance Liquid chromatography
g) Ultra High Performance Liquid chromatography
h) Affinity chromatography
i) Gel Chromatography

5 Electrophoresis: Principle, Instrumentation, Working conditions, factors affecting 8 Hrs


separation and applications of the following:
a) Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis d) Zone
electrophoresis e) Moving boundary electrophoresis f) Iso electric focusing
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.
6 Potentiometry: Principle, working, Ion selective Electrodes and Application of 4 Hrs
potentiometry.
Thermal Analysis: Polymer behavior, factors affecting and instrumentation, and
working, application of TGA

REFERENCES (Latest edition to be recommended)


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

183
QUALITY MANAGEMENT SYSTEMS (MQA101T)

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

184
12 Hrs

2. 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.

12 Hrs

3. 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.
12 Hrs

4. 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
12 Hrs

5. 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.
8Hrs

6. Regulatory Compliance through Quality Management and development of


Quality Culture

185
Benchmarking: Definition of benchmarking, Reasons for benchmarking, Types of
Benchmarking, Benchmarking process, Advantages of benchmarking, Limitations of
benchmarking
4 Hrs

REFERENCES:

1. Implementing Juran's Road Map for Quality Leadership: Benchmarks and Results, By
Al Endres, Wiley, 2000
2. Understanding, Managing and Implementing Quality: Frameworks, Techniques and
Cases, By Jiju Antony; David Preece, Routledge, 2002
3. 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
4. Corporate Culture and the Quality Organization By James W. Fairfield-Sonn, Quorum
Books, 2001
5. The Quality Management Sourcebook: An International Guide to Materials and
Resources By Christine Avery; Diane Zabel, Routledge, 1997
6. The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ Publications
7. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De Feo, ASQ
Publications
8. Root Cause Analysis, The Core of Problem Solving and Corrective Action, Duke
Okes, 2009, ASQ Publications

186
QUALITY CONTROL AND QUALITY ASSURANCE (MQA102T)
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.
12 Hrs

2. 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.
12 Hrs

187
3. 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.
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).
10 Hrs

4. 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.
12 Hrs

5. 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.
12 Hrs

REFERENCES
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.

188
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.

189
PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER (MQA103T)
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.
12 Hrs

2. Preformulation 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. Preformulation protocol, Stability
testing during product development.
12 Hrs

3. 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

4. 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

190
modern drug packaging, Selection and evaluation of Pharmaceutical packaging
materials.
Quality control test: Containers, closures and secondary packing materials.
12 Hrs

5. 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

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.

191
QUALITY ASSURANCE PRACTICAL-I (MQA104P)

PRACTICALS

1. Analysis of pharmacopoeial compounds in bulk and in their formulations (tablet/


capsules/ semisolids) by UV Vis spectrophotometer
2. Simultaneous estimation of multi-drug component containing formulations by UV
spectrophotometry
3. Experiments based on HPLC
4. Experiments based on Gas Chromatography
5. Estimation of riboflavin/quinine sulphate by fluorimetry
6. Estimation of sodium/potassium by flame photometry or AAS
7. 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
8 Development of Stability study protocol
9. Estimation of process capability
11. In process and finished product quality control tests for tablets, capsules, parenterals
and semisolid dosage forms.
12. Assay of raw materials as per official monographs
13. Testing of related and foreign substances in drugs and raw materials
14. To carry out pre formulation study for tablets, parenterals (2 experiment).
15. To study the effect of pH on the solubility of drugs, (1 experiment)
16. Quality control tests for Primary and secondary packaging materials
17. Accelerated stability studies (1 experiment)
18. Improved solubility of drugs using surfactant systems (1 experiment)
19. Improved solubility of drugs using co-solvency method (1 experiment)
20. Determination of Pka and Log p of drugs.

192
HAZARDS AND SAFETY MANAGEMENT (MPA201T)

Scope

This course is designed to convey the knowledge necessary to understand issues


related to different kinds of hazard and their management. Basic theoretical and practical
discussions integrate the proficiency to handle the emergency situation in the
pharmaceutical product development process and provides the principle based approach to
solve the complex tribulations.

Objectives

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

 Understand about environmental problems among learners.


 Impart basic knowledge about the environment and its allied problems.
 Develop an attitude of concern for the industry environment.
 Ensure safety standards in pharmaceutical industry
 Provide comprehensive knowledge on the safety management
 Empower an ideas to clear mechanism and management in different kinds of
hazard management system
 Teach the method of Hazard assessment, procedure, methodology for provide safe
industrial atmosphere.

THEORY
60Hrs

1. Multidisciplinary nature of environmental studies: Natural Resources, Renewable


and non-renewable resources, Natural resources and associated problems, a) Forest
resources; b) Water resources; c) Mineral resources; d) Energy resources; e) Land
resources
Ecosystems: Concept of an ecosystem and Structure and function of an ecosystem.
Environmental hazards: Hazards based on Air, Water, Soil and Radioisotopes.

12 Hrs
2. Air based hazards: Sources, Types of Hazards, Air circulation maintenance industry
for sterile area and non sterile area, Preliminary Hazard Analysis (PHA)
Fire protection system: Fire prevention, types of fire extinguishers and critical Hazard
management system.
12 Hrs

193
3. Chemical based hazards: Sources of chemical hazards, Hazards of Organic synthesis,
sulphonating hazard, Organic solvent hazard, Control measures for chemical hazards,
Management of combustible gases, Toxic gases and Oxygen displacing gases
management, Regulations for chemical hazard, Management of over-Exposure to
chemicals and TLV concept.
12 Hrs

4. Fire and Explosion: Introduction, Industrial processes and hazards potential,


mechanical electrical, thermal and process hazards. Safety and hazards regulations,
Fire protection system: Fire prevention, types of fire extinguishers and critical Hazard
management system mechanical and chemical explosion, multiphase reactions,
transport effects and global rates. Preventive and protective management from fires
and explosion- electricity passivation, ventilation, and sprinkling, proofing, relief
systems -relief valves, flares, scrubbers. 12 Hrs
5. Hazard and risk management: Self-protective measures against workplace hazards.
Critical training for risk management, Process of hazard management, ICH guidelines
on risk assessment and Risk management methods and Tools
Factory act and rules, fundamentals of accident prevention, elements of safety
programme and safety management, Physicochemical measurements of effluents,
BOD, COD, Determination of some contaminants, Effluent treatment procedure, Role
of emergency services
12 Hrs

REFERENCES:

1. Y.K. Sing, Environmental Science, New Age International Pvt, Publishers, Bangalore
2. “Quantitative Risk Assessment in Chemical Process Industries” American Institute of
Chemical Industries, Centre for Chemical Process safety.
3. Bharucha Erach, The Biodiversity of India, Mapin Pu blishing Pvt. Ltd., Ahmedabad –
380 013, India,
4. Hazardous Chemicals: Safety Management and Global Regulations, T.S.S. Dikshith,
CRC press

194
PHARMACEUTICAL VALIDATION (MQA202T)

Scope
The main purpose of the subject is to understand about validation and how it can be
applied to industry and thus improve the quality of the products. The subject covers the
complete information about validation, types, methodology and application.

Objectives

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

 The concepts of calibration, qualification and validation


 The qualification of various equipments and instruments
 Process validation of different dosage forms
 Validation of analytical method for estimation of drugs
 Cleaning validation of equipments employed in the manufacture of
pharmaceuticals

THEORY
60 Hrs

1. Introduction to validation: Definition of Calibration, Qualification and Validation,


Scope, frequency and importance. Difference between calibration and validation.
Calibration of weights and measures. Advantages of Validation, scope of Validation,
Organization for Validation, Validation Master plan, Types of Validation,
Streamlining of qualification & Validation process and Validation Master Plan.
Qualification: User requirement specification, Design qualification, Factory
Acceptance Test (FAT)/Site Acceptance Test (SAT), Installation qualification,
Operational qualification, Performance qualification, Re-Qualification (Maintaining
status- Calibration Preventive Maintenance, Change management).
12 Hrs

2. Qualification of manufacturing equipment: Dry Powder Mixers, Fluid Bed and


Tray dryers, Tablet Compression (Machine), Dry heat sterilization/Tunnels,
Autoclaves, Membrane filtration, Capsule filling machine.

195
Qualification of analytical instruments: UV-Visible spectrophotometer, FTIR, DSC,
GC, HPLC, HPTLC, LC-MS.
12 Hrs

3. Qualification of laboratory equipments: Hardness tester, Friability test apparatus,


tap density tester, Disintegration tester, Dissolution test apparatus
Validation of Utility systems: Pharmaceutical water system & pure steam, HVAC
system, Compressed air and nitrogen.
12 Hrs

4. Process Validation: Concept, Process and documentation of Process Validation.


Prospective, Concurrent & Retrospective Validation, Re validation criteria, Process
Validation of various formulations (Coated tablets, Capsules, Ointment/Creams,
Liquid Orals and aerosols.), Aseptic filling: Media fill validation, USFDA guidelines
on Process Validation- A life cycle approach.
Analytical method validation: General principles, Validation of analytical method as
per ICH guidelines (Q2) and USP.
12 Hrs

5. Cleaning Validation: Cleaning Method development, Validation of analytical method


used in cleaning, Cleaning of Equipment, Cleaning of Facilities. Cleaning in place
(CIP).
Validation of facilities in sterile and non-sterile plant.
Computerized system validation: Electronic records and digital signature - 21 CFR
Part 11 and GAMP 5.
12 Hrs

REFERENCES:

1. B. T. Loftus & R. A. Nash, "Pharmaceutical Process Validation", Drugs and Pharm


Sci. Series, Vol. 129, 3rd Ed., Marcel Dekker Inc., N.Y.
2. The Theory & Practice of Industrial Pharmacy, 3rd edition, Leon Lachman, Herbert A.
Lieberman, Joseph. L. Karig, Varghese Publishing House, Bombay.
3. Validation Master plan by Terveeks or Deeks, Davis Harwood International
publishing.
4. Validation of Aseptic Pharmaceutical Processes, 2nd Edition, by Carleton & Agalloco,
(Marcel Dekker).
5. Michael Levin, Pharmaceutical Process Scale-Up”, Drugs and Pharm. Sci. Series, Vol.

196
157,2nd Ed., Marcel Dekker Inc., N.Y.
6. Validation Standard Operating Procedures: A Step by Step Guide for Achieving
Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Syed
Imtiaz Haider
7. Pharmaceutical Equipment Validation: The Ultimate Qualification Handbook, Phillip
A. Cloud, Interpharm Press
8. Validation of Pharmaceutical Processes: Sterile Products, Frederick J. Carlton (Ed.)
and James Agalloco (Ed.), Marcel Dekker
9. Analytical Method validation and Instrument Performance Verification by Churg
Chan, Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Interscience.
10. Huber L. Validation and Qualification in Analytical Laboratories. Informa Healthcare
11. Wingate G. Validating Corporate Computer Systems: Good IT Practice for
Pharmaceutical Manufacturers. Interpharm Press
12. LeBlanc DA. Validated Cleaning Technologies for Pharmaceutical Manufacturing.
Interpharm Press

197
AUDITS AND REGULATORY COMPLIANCE (MPA203T)

Scope:

This course deals with the understanding and process for auditing in
pharmaceutical industries. This subject covers the methodology involved in the auditing
process of different in pharmaceutical industries.

Objectives:

Upon completion of this course the student should be able to

 To understand the importance of auditing


 To understand the methodology of auditing
 To carry out the audit process
 To prepare the auditing report
 To prepare the check list for auditing

THEORY
60 Hrs

1. Introduction: Objectives, Management of audit, Responsibilities, Planning process,


information gathering, administration, Classifications of deficiencies
12 Hrs

2. Role of quality systems and audits in pharmaceutical manufacturing


environment: cGMP Regulations, Quality assurance functions, Quality systems
approach, Management responsibilities, Resource, Manufacturing operations,
Evaluation activities, Transitioning to quality system approach, Audit checklist for
drug industries.
1
2
Hrs

3. Auditing of vendors and production department: Bulk Pharmaceutical Chemicals


and packaging material Vendor audit, Warehouse and weighing, Dry Production:
Granulation, tableting, coating, capsules, sterile production and packaging.
1
2
Hrs

4. Auditing of Microbiological laboratory: Auditing the manufacturing process,

198
Product and process information, General areas of interest in the building raw
materials, Water, Packaging materials.
12 Hrs

5. Auditing of Quality Assurance and engineering department: Quality Assurance


Maintenance, Critical systems: HVAC, Water, Water for Injection systems, ETP.
12 Hrs

REFERENCES
1. Compliance auditing for Pharmaceutical Manufacturers. Karen Ginsbury and Gil
Bismuth, Interpharm/CRC, Boca Raton, London New York, Washington D.C.
2. Pharmaceutical Manufacturing Handbook, Regulations and Quality by Shayne Cox
Gad. Wiley-Interscience, A John Wiley and sons, Inc., Publications.
3. Handbook of microbiological Quality control. Rosamund M. Baird, Norman A.
Hodges, Stephen P. Denyar. CRC Press. 2000.
4. Laboratory auditing for quality and regulatory compliance. Donald C. Singer, Raluca-
loana Stefan, Jacobus F. Van Staden. Taylor and Francis (2005).

199
PHARMACEUTICAL MANUFACTURING TECHNOLOGY (MPA204T)

Scope

This course is designed to impart knowledge and skills necessary to train the
students with the industrial activities during Pharmaceutical Manufacturing.

Objectives

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

 The common practice in the pharmaceutical industry developments, plant layout and
production planning
 Will be familiar with the principles and practices of aseptic process technology, non
sterile manufacturing technology and packaging technology.
 Have a better understanding of principles and implementation of Quality by design
(QbD) and process analytical technology (PAT) in pharmaceutical manufacturing

THEORY
60Hrs

1. Pharmaceutical industry developments: Legal requirements and Licenses for API


and formulation industry, Plant location-Factors influencing.
Plant layout: Factors influencing, Special provisions, Storage space requirements,
sterile and aseptic area layout.
Production planning: General principles, production systems, calculation of
standard cost, process planning, routing, loading, scheduling, dispatching of records,
production control.
1
2H
rs

2. Aseptic process technology: Manufacturing, manufacturing flowcharts, in process-


quality control tests for following sterile dosage forms: Ointment, Suspension and
Emulsion, Dry powder, Solution (Small Volume & large Volume).

200
Advanced sterile product manufacturing technology : Area planning &
environmental control, wall and floor treatment, fixtures and machineries, change
rooms, personnel flow, utilities & utilities equipment location, engineering and
maintenance.
Process Automation in Pharmaceutical Industry: With specific reference to
manufacturing of sterile semisolids, Small Volume Parenterals & Large Volume
Parenterals (SVP & LVP), Monitoring of Parenteral manufacturing facility, Cleaning
in Place (CIP), Sterilization in Place (SIP), Prefilled Syringe, Powdered Jet, Needle
Free Injections, and Form Fill Seal Technology (FFS).
Lyophilization technology: Principles, process, equipment.
12Hrs

3. Non sterile manufacturing process technology: Manufacturing, manufacturing


flowcharts, in process-quality control tests for following Non-Sterile solid dosage
forms: Tablets (compressed & coated), Capsules (Hard & Soft).
Advance non-sterile solid product manufacturing technology: Process Automation
in Pharmaceutical Industry with specific reference to manufacturing of tablets and
coated products, Improved Tablet Production: Tablet production process, granulation
and pelletization equipments, continuous and batch mixing, rapid mixing granulators,
rota granulators, spheronizers and marumerisers, and other specialized granulation
and drying equipments. Problems encountered.
Coating technology: Process, equipments, particle coating, fluidized bed coating,
application techniques. Problems encountered.
12Hrs

4. Containers and closures for pharmaceuticals: Types, performance, assuring quality


of glass; types of plastics used, Drug plastic interactions, biological tests, modification
of plastics by drugs; different types of closures and closure liners; film wrapper;
blister packs; bubble packs; shrink packaging; foil / plastic pouches, bottle seals, tape
seals, breakable seals and sealed tubes; quality control of packaging material and
filling equipment, flexible packaging, product package compatibility, transit

201
worthiness of package, Stability aspects of packaging. Evaluation of stability of
packaging material.
1
2H
rs

5. Quality by design (QbD) and process analytical technology (PAT): Current


approach and its limitations. Why QbD is required, Advantages, Elements of QbD,
Terminology: QTPP. CMA, CQA, CPP, RLD, Design space, Design of Experiments,
Risk Assessment and mitigation/minimization. Quality by Design, Formulations by
Design, QbD for drug products, QbD for Drug Substances, QbD for Excipients,
Analytical QbD. FDA initiative on process analytical technology. PAT as a driver for
improving quality and reducing costs: quality by design (QbD), QA, QC and GAMP.
PAT guidance, standards and regulatory requirements.

REFERENCES

1. Lachman L, Lieberman HA, Kanig JL. The theory and practice of industrial pharmacy,
rd
3 ed., Varghese Publishers, Mumbai 1991.
th
2. Sinko PJ. Martin's physical pharmacy and pharmaceutical sciences, 5 ed., B.I.
Publications Pvt. Ltd, Noida, 2006.
3. Lieberman HA, Lachman L, Schwartz JB. Pharmaceutical dosage forms: tablets Vol. I-
nd
III, 2 ed., CBS Publishers & distributors, New Delhi, 2005.
th
4. Banker GS, Rhodes CT. Modern Pharmaceutics, 4 ed., Marcel Dekker Inc, New
York, 2005.
5. 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.
6. Indian Pharmacopoeia. Controller of Publication. Delhi, 1996.
7. British Pharmacopoeia. British Pharmacopoeia Commission Office, London, 2008.

8. United States Pharmacopoeia. United States Pharmacopeial Convention, Inc, USA,

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