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M.Pharm Pharmaceutical Quality Assurance Syllabus

Pharmaceutical Quality Assurance is the M.Pharm specialisation on quality systems, validation and regulatory compliance in pharmaceutical manufacturing. This page gives the complete syllabus of the branch as prescribed by the Pharmacy Council of India, subject by subject and unit by unit.

Source: Pharmacy Council of India (PCI), The Revised Regulations for the Master of Pharmacy Degree Program, Credit Based Semester System, and the M.Pharm syllabus prescribed by the Pharmacy Council of India. The syllabus below is reproduced from the PCI syllabus, unit by unit.

Semester 1

MQA101T Modern Pharmaceutical Analytical Techniques

Unit 1: Spectroscopy I

Unit 2: 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.

Unit 3: 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, metastable ions, isotopic peaks, applications of mass spectroscopy.

Unit 4: Chromatography

Principle, apparatus, instrumentation, chromatographic parameters, factors affecting resolution, isolation of drug from excipients, data interpretation and applications of: 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.

Unit 5: Electrophoresis and X-ray crystallography

Electrophoresis: principle, instrumentation, working conditions, factors affecting separation and applications of paper electrophoresis, gel electrophoresis, capillary electrophoresis, zone electrophoresis, moving boundary electrophoresis, isoelectric focusing. X-ray crystallography: production of X rays, different X ray diffraction methods, Bragg law, rotating crystal technique, X ray powder technique, types of crystals, applications of X ray diffraction.

Unit 6: Potentiometry and thermal techniques

Potentiometry: principle, working, ion selective electrodes, applications. Thermal techniques: principle, thermal transitions and instrumentation (heat flux and power compensation designs), modulated DSC, hyper DSC, experimental parameters (sample preparation, experimental conditions, calibration, heating and cooling rates, resolution, source of errors) and their influence, advantages and disadvantages, pharmaceutical applications. Differential thermal analysis (DTA): principle, instrumentation, advantages and disadvantages, pharmaceutical applications, derivative differential thermal analysis (DDTA). TGA: principle, instrumentation, factors affecting results, advantages and disadvantages, pharmaceutical applications.

MQA102T Quality Management System

Unit 1: Introduction to Quality

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.

Unit 2: Pharmaceutical quality Management

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. OHSAS guidelines, NABL certification and accreditation, CFR-21 part 11, WHO-GMP requirements.

Unit 3: Six System Inspection model

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.

Unit 4: Drug Stability

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.

Unit 5: Statistical Process control (SPC)

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.

Unit 6: Regulatory Compliance through Quality Management

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.

MQA103T Quality Control and Quality Assurance

Unit 1: Introduction

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.

Unit 2: cGMP 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.

Unit 3: Analysis of raw materials, finished products and packaging materials

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).

Unit 4: Documentation in pharmaceutical industry

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.

Unit 5: Manufacturing operations and controls

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.

MQA104T Product Development and Technology Transfer

Unit 1: Principles of Drug discovery and development

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.

Unit 2: Pre-formulation studies

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, cosolvency. Techniques for the study of Crystal properties and polymorphism. Pre-formulation protocol, Stability testing during product development.

Unit 3: Pilot plant scale up

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.

Unit 4: Pharmaceutical packaging

Pharmaceutical packaging: Pharmaceutical dosage form and their packaging requirements, 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.

Unit 5: Technology transfer

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.

Practicals and Seminar

Semester 2

MQA201T Hazards and Safety Management

Unit 1: Multidisciplinary nature of environmental studies

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.

Unit 2: Air based hazards

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.

Unit 3: Chemical based hazards

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.

Unit 4: Fire and Explosion

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.

Unit 5: Hazard and risk management

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.

MQA202T Pharmaceutical Validation

Unit 1: Introduction to validation

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, ReQualification (Maintaining status, Calibration Preventive Maintenance, Change management).

Unit 2: Qualification of manufacturing equipment

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

Unit 3: Qualification of laboratory equipments

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.

Unit 4: Process Validation

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 and USP.

Unit 5: Cleaning Validation

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.

Unit 6: General Principles of Intellectual Property

General Principles of Intellectual Property: Concepts of Intellectual Property (IP), Intellectual Property Protection (IPP), Intellectual Property Rights (IPR); Economic importance, mechanism for protection of Intellectual Property, patents, Copyright, Trademark; Factors affecting choice of IP protection; Penalties for violation; Role of IP in pharmaceutical industry; Global ramification and financial implications. Filing a patent applications; patent application forms and guidelines. Types patent applications, provisional and non provisional, PCT and convention patent applications; International patenting requirement procedures and costs; Rights and responsibilities of a patentee; Practical aspects regarding maintaining of a Patent file; Patent infringement meaning and scope. Significance of transfer technology (TOT), IP and ethics, positive and negative aspects of IPP; Societal responsibility, avoiding unethical practices.

MQA203T Audits and Regulatory Compliance

Unit 1: Introduction

Introduction: Objectives, Management of audit, Responsibilities, Planning process, information gathering, administration, Classifications of deficiencies.

Unit 2: Role of quality systems and audits in pharmaceutical manufacturing environment

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.

Unit 3: Auditing of vendors and production department

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.

Unit 4: Auditing of Microbiological laboratory

Auditing of Microbiological laboratory: Auditing the manufacturing process, Product and process information, General areas of interest in the building, raw materials, Water, Packaging materials.

Unit 5: Auditing of Quality Assurance and engineering department

Auditing of Quality Assurance and engineering department: Quality Assurance Maintenance, Critical systems: HVAC, Water, Water for Injection systems, ETP.

MQA204T Pharmaceutical Manufacturing Technology

Unit 1: Pharmaceutical industry developments

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.

Unit 2: Aseptic process technology

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). 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.

Unit 3: Non sterile manufacturing process technology

Non sterile manufacturing process technology: Manufacturing, manufacturing flowcharts, in process-quality control tests for following NonSterile 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.

Unit 4: Containers and closures for pharmaceuticals

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 worthiness of package, Stability aspects of packaging. Evaluation of stability of packaging material.

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

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.

Practicals and Seminar

Semester 3 and 4

Semester 3 and Semester 4 are common to all M.Pharm specialisations: Research Methodology and Biostatistics (MRM301T), Journal Club, Discussion / Presentation and Research Work. See the M.Pharm common syllabus page for the full common syllabus.