MPY-201-IP : Pharmaceutical Quality Assurance
Pharmaceutical Quality Management System: Total Quality Management (TQM), six sigma concept, Quality by Design (QbD) vs Quality by Testing (QbT) concept, Official and non- official quality control tests for tablets, capsules, liquid orals, semisolids, injectables and other sterile products with their acceptable limits as per official books and regulatory requirements. In- process quality control (IPQC) testing of dosage forms.
Quality assurance in contract manufacturing. Sources and control of quality variation- material, machine, man, method and environment. Quality testing of raw material, in-process material and finished products. Quality assurance in analytical laboratory. Quality assurance concepts in pharmaceutical packaging operations.
Pharmaceutical manufacturing documentation (PMD) – Guidelines for designing and implementation of PMD programme. Advantages and applications of pharmaceutical documentation, Regulatory requirement of pharmaceutical documentation: Standard practices in preparation, issue, use and archival of documents, records, reports and disposal of documents.
Validation of pharmaceutical manufacturing facility: Purpose, approaches, planning, change control. Area qualification of non-sterile production area. Qualification of sterile production area, media fill test, aseptic processing area. Validation of pharmaceutical plant utilities: Pharmaceutical water system, HVAC system, air handling, air change system, environmental control system.
Organizational & personnel responsibilities. training and records. equipment selection, User Requirement Specifications (URS), maintenance of analytical instruments. Standard practices in Quality control laboratory, Calibration and certification of equipments. Validation of disinfectants, Validation of cleaning and sanitization of clean room and materials.
Pharmaceutical Process Validation – Robert A. Nash, Alfred H. Wachter
Process Validation in manufacturing of biopharmaceuticals: Guidelines – Anurag Singh Rathore, Gail Sofer, G. K. Sofer
Pharmaceutical Quality Assurance – Manohar A. Potdar
Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials (v. 1) by WHO.
The Pharmaceutical Regulatory Process, 2nd ed. – Ira R. Berry, Robert P. Martin
Medical Product Regulatory Affairs: Pharmaceutical , Diagnostics, Medical Devices – John J. Tobin and Gary Walsh
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Biologics, 2nd ed. – Douglas J. Pisano and David S. Mantus
Good Drug Regulatory Practices: a Regulatory Affairs Quality Manual (Good Drug Development Series) – Helene I. Dumitriu
MPY- 202-IP : Industrial Management
Pharmaceutical Management: Meaning, Process of management: Planning, organizing, staffing, directing, coordinating and controlling- a preliminary idea of concepts, processes and techniques. Fundamental concepts of production, financial, personal, legal and marketing functions with special reference to Pharmaceutical Management. Introduction to budgeting, costing, auditing and budgetary control. Entrepreneurship development.
Production management: Fundamentals of production, organization, economic policy, manufacturing economic, production capacities, production lines and job balancing, visible and invisible inputs, methodology of activities. Development of efficient work methods, quality control and management of R&D. Pharmaceutical quality management system.
Production planning and control, production processes- mass job and project; plant location and lay out; work study, materials management-purchase, inventory control and store keeping. Different techniques of inventory management. Productivity management: concepts problems, tools and techniques for improvement. Operation research techniques by PERT and CPM.
Consideration for design of large scale manufacturing units including intricate design criteria for units to manufacture sterile and non-sterile products with special reference to tablets, capsule, injections and special dosage forms.
Design and development of packaging units including recent advances in packaging techniques for various types of sterile and non-sterile dosage form. Warehouse design, construction, maintenance and sanitation; Cost effective design, good warehousing practice.
Principles and Methods of Pharmacy Management III rd edition Harry A. Smith
Management “Global Perspective Heinz Weihrich, Harold Koontz by Tata Mcgraw Hill.
Guidelines for Developing National Drug Policies; WHO Publications, 1998.
A Guide to Total Quality Management by Kaushik Maitra and Sedhan K. Ghosh.
ISO 9000 and Total Quality Management by Sadhan K. Ghosh.
Business Organization and Management by Shukla M. C.; S. Chand and Company
Personal Management by Filippo E. B. Mac Graw Hill.
Personal Management Tripathi P. C.; S. Chand and Company.
Project Management by Choudhary, S.; Tata Mac Graw Hill.
MPY- 203-IP: PHARMACEUTICAL REGULATIONS
FDA’s Product Approval Processes
New Drug Approval Process.
Generic Drug Approval Process.
Biologics Approval Process.
USFDA: Regulations. Effects of patent and trademark laws. Patent certification in drug approvals.
Requirements of cGMP with specific reference of USFDA (21 CFR part 210 and 211), European Medicines Agency (EMEA) guidelines.
Overview of GMP guidelines with specific reference of World health organization (WHO), Medicines and Healthcare products Regulatory Agency (MHRA), Medicines control council (MCC), Therapeutic goods administration (TGA) and ANVISA brazil guidelines.
Guidance for Industry: IR/ MR Solid Oral Dosage Forms Scale - Up and Postapproval Changes (SUPAC)-Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
Guidance for Industry: Sterile/Non Sterile Semisolid Dosage Forms Scale - Up and Postapproval Changes (SUPAC)-Chemistry, Manufacturing and Controls, In Vitro Release Testing, and In Vivo Bioequivalence Documentation
Guidance for Industry : Dissolution testing of immediate release solid oral dosage forms.
Guidance for Industry : Extended release oral dosage forms: Development, evaluation and application of In Vitro/In Vivo Correlations.
Guidance for Industry : Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System Unit V
The role of patents in the approval process
The Patent Listing (“Orange Book”) Requirement
The “Paragraph IV” Certification and Notice Requirement
ANDA Filing As An Act of Infringement
The Automatic 30-Month Stay of ANDA Approval
180-Day Exclusivity for first paragraph IV filers
I. R. Berry, The pharmaceutical regulatory process, Marcel dekker.
L. Shargel, I. Kanfer, Generic drug product development solid oral dosage forms, Marcel dekker.
MPY- 204-IP : PHARMACEUTICAL PACKAGING TECHNOLOGY
Functions of packaging, Packaging management, Package development, packaging and stability, packaging specification, Regulatory aspects of pharmaceutical packaging. Packaging material science: Basic materials used in packaging, their properties, method of manufacturing and applications-Paper, Plastics, Glass, Metal, and Elastomers.
Containers and closures: Closure Systems: Basis of closure system, Types/mechanism of closure system, Sealing and adhesion techniques, Materials used for closure systems.
Introduction and applications of Glass containers, Plastic containers, Collapsible tubes, Plastic tubes, Aerosol containers, Closures, Liners, and Rubber stoppers.
Introduction and applications of Form-Fill-Seal (FFS) technology.
Packaging techniques and machineries: Tamper resistant and child resistant packages: Introduction, method of preparation, and applications of Blister and Strip packs, Film Wrappers, Bubble packs, Shrink seals, Sachet and Pouches, Tape seals, Breakable caps, Sealed tubes, Aerosol containers, etc.
Quality control and quality assurance of packaging materials: Detection of defects in packaging materials, Quality testing of formed packs, Quality testing of containers and closures, Testing of child resistance and temper evidence property of packaging materials. Quality control tests for containers and closures as per Indian Pharmacopoeia.
Legal and regulatory requirements: Requirements of labels and labeling as per Drug & Cosmetics act and rules. Product / patient information literatures. Regulatory aspects of storage, handling and distribution of packaging materials with special emphasis on cGMP and cGLP requirements.
Books recommended:
Dean, D.A.; Evans, E.R.; and Hall I.H., Pharmaceutical Packaging Technology.
Leon Lachman, Herbert A. Lieberman, Joseph L. Kanig, The Theory and Practice of Industrial Pharmacy.
Drug and cosmetic Act and Rules.
MPY-201-IP : Pharmaceutical Quality Assurance
Pharmaceutical Quality Management System: Total Quality Management (TQM), six sigma concept, Quality by Design (QbD) vs Quality by Testing (QbT) concept, Official and non- official quality control tests for tablets, capsules, liquid orals, semisolids, injectables and other sterile products with their acceptable limits as per official books and regulatory requirements. In- process quality control (IPQC) testing of dosage forms.
Quality assurance in contract manufacturing. Sources and control of quality variation- material, machine, man, method and environment. Quality testing of raw material, in-process material and finished products. Quality assurance in analytical laboratory. Quality assurance concepts in pharmaceutical packaging operations.
Pharmaceutical manufacturing documentation (PMD) – Guidelines for designing and implementation of PMD programme. Advantages and applications of pharmaceutical documentation, Regulatory requirement of pharmaceutical documentation: Standard practices in preparation, issue, use and archival of documents, records, reports and disposal of documents.
Validation of pharmaceutical manufacturing facility: Purpose, approaches, planning, change control. Area qualification of non-sterile production area. Qualification of sterile production area, media fill test, aseptic processing area. Validation of pharmaceutical plant utilities: Pharmaceutical water system, HVAC system, air handling, air change system, environmental control system.
Organizational & personnel responsibilities. training and records. equipment selection, User Requirement Specifications (URS), maintenance of analytical instruments. Standard practices in Quality control laboratory, Calibration and certification of equipments. Validation of disinfectants, Validation of cleaning and sanitization of clean room and materials.
Pharmaceutical Process Validation – Robert A. Nash, Alfred H. Wachter
Process Validation in manufacturing of biopharmaceuticals: Guidelines – Anurag Singh Rathore, Gail Sofer, G. K. Sofer
Pharmaceutical Quality Assurance – Manohar A. Potdar
Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials (v. 1) by WHO.
The Pharmaceutical Regulatory Process, 2nd ed. – Ira R. Berry, Robert P. Martin
Medical Product Regulatory Affairs: Pharmaceutical , Diagnostics, Medical Devices – John J. Tobin and Gary Walsh
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Biologics, 2nd ed. – Douglas J. Pisano and David S. Mantus
Good Drug Regulatory Practices: a Regulatory Affairs Quality Manual (Good Drug Development Series) – Helene I. Dumitriu
MPY- 202-IP : Industrial Management
Pharmaceutical Management: Meaning, Process of management: Planning, organizing, staffing, directing, coordinating and controlling- a preliminary idea of concepts, processes and techniques. Fundamental concepts of production, financial, personal, legal and marketing functions with special reference to Pharmaceutical Management. Introduction to budgeting, costing, auditing and budgetary control. Entrepreneurship development.
Production management: Fundamentals of production, organization, economic policy, manufacturing economic, production capacities, production lines and job balancing, visible and invisible inputs, methodology of activities. Development of efficient work methods, quality control and management of R&D. Pharmaceutical quality management system.
Production planning and control, production processes- mass job and project; plant location and lay out; work study, materials management-purchase, inventory control and store keeping. Different techniques of inventory management. Productivity management: concepts problems, tools and techniques for improvement. Operation research techniques by PERT and CPM.
Consideration for design of large scale manufacturing units including intricate design criteria for units to manufacture sterile and non-sterile products with special reference to tablets, capsule, injections and special dosage forms.
Design and development of packaging units including recent advances in packaging techniques for various types of sterile and non-sterile dosage form. Warehouse design, construction, maintenance and sanitation; Cost effective design, good warehousing practice.
Principles and Methods of Pharmacy Management III rd edition Harry A. Smith
Management “Global Perspective Heinz Weihrich, Harold Koontz by Tata Mcgraw Hill.
Guidelines for Developing National Drug Policies; WHO Publications, 1998.
A Guide to Total Quality Management by Kaushik Maitra and Sedhan K. Ghosh.
ISO 9000 and Total Quality Management by Sadhan K. Ghosh.
Business Organization and Management by Shukla M. C.; S. Chand and Company
Personal Management by Filippo E. B. Mac Graw Hill.
Personal Management Tripathi P. C.; S. Chand and Company.
Project Management by Choudhary, S.; Tata Mac Graw Hill.
MPY- 203-IP: PHARMACEUTICAL REGULATIONS
FDA’s Product Approval Processes
New Drug Approval Process.
Generic Drug Approval Process.
Biologics Approval Process.
USFDA: Regulations. Effects of patent and trademark laws. Patent certification in drug approvals.
Requirements of cGMP with specific reference of USFDA (21 CFR part 210 and 211), European Medicines Agency (EMEA) guidelines.
Overview of GMP guidelines with specific reference of World health organization (WHO), Medicines and Healthcare products Regulatory Agency (MHRA), Medicines control council (MCC), Therapeutic goods administration (TGA) and ANVISA brazil guidelines.
Guidance for Industry: IR/ MR Solid Oral Dosage Forms Scale - Up and Postapproval Changes (SUPAC)-Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
Guidance for Industry: Sterile/Non Sterile Semisolid Dosage Forms Scale - Up and Postapproval Changes (SUPAC)-Chemistry, Manufacturing and Controls, In Vitro Release Testing, and In Vivo Bioequivalence Documentation
Guidance for Industry : Dissolution testing of immediate release solid oral dosage forms.
Guidance for Industry : Extended release oral dosage forms: Development, evaluation and application of In Vitro/In Vivo Correlations.
Guidance for Industry : Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System Unit V
The role of patents in the approval process
The Patent Listing (“Orange Book”) Requirement
The “Paragraph IV” Certification and Notice Requirement
ANDA Filing As An Act of Infringement
The Automatic 30-Month Stay of ANDA Approval
180-Day Exclusivity for first paragraph IV filers
I. R. Berry, The pharmaceutical regulatory process, Marcel dekker.
L. Shargel, I. Kanfer, Generic drug product development solid oral dosage forms, Marcel dekker.
MPY- 204-IP : PHARMACEUTICAL PACKAGING TECHNOLOGY
Functions of packaging, Packaging management, Package development, packaging and stability, packaging specification, Regulatory aspects of pharmaceutical packaging. Packaging material science: Basic materials used in packaging, their properties, method of manufacturing and applications-Paper, Plastics, Glass, Metal, and Elastomers.
Containers and closures: Closure Systems: Basis of closure system, Types/mechanism of closure system, Sealing and adhesion techniques, Materials used for closure systems.
Introduction and applications of Glass containers, Plastic containers, Collapsible tubes, Plastic tubes, Aerosol containers, Closures, Liners, and Rubber stoppers.
Introduction and applications of Form-Fill-Seal (FFS) technology.
Packaging techniques and machineries: Tamper resistant and child resistant packages: Introduction, method of preparation, and applications of Blister and Strip packs, Film Wrappers, Bubble packs, Shrink seals, Sachet and Pouches, Tape seals, Breakable caps, Sealed tubes, Aerosol containers, etc.
Quality control and quality assurance of packaging materials: Detection of defects in packaging materials, Quality testing of formed packs, Quality testing of containers and closures, Testing of child resistance and temper evidence property of packaging materials. Quality control tests for containers and closures as per Indian Pharmacopoeia.
Legal and regulatory requirements: Requirements of labels and labeling as per Drug & Cosmetics act and rules. Product / patient information literatures. Regulatory aspects of storage, handling and distribution of packaging materials with special emphasis on cGMP and cGLP requirements.
Books recommended:
Dean, D.A.; Evans, E.R.; and Hall I.H., Pharmaceutical Packaging Technology.
Leon Lachman, Herbert A. Lieberman, Joseph L. Kanig, The Theory and Practice of Industrial Pharmacy.
Drug and cosmetic Act and Rules.