book

Supply Chain Management in Pharmaceutical Industry by Pearson

Name: Supply Chain Management in Pharmaceutical Industry by Pearson
ISBN: 9789361597640

by Avadhut C. Sukhtankar, Sanjiv M. Haldankar,, P. M. Wadekar,, Neel Sharma,, Rajeev P. Patil

April 2024

Intermediate to advanced

998 pages

14h 52m

English

Pearson India

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Cover
About Pearson
Title Page
Contents
Preface
Acknowledgements
About the Authors
Part A
Chapter 1: Introduction to Pharmaceutical Industry in India
1.1 History of Indian Pharma Industry1.2 Prior to Indian Patent Act 19701.3 Period Between 1970 and 19801.4 Indian Pharma Industries After 19901.5 Indian Pharma Industry Today1.6 Public Sector in Pharmaceutical Industry1.7 Contributions of Research Laboratories1.8 Patents and Pharma Industry1.9 Indian Patent Act and Pharma Industry1.10 The US and the Indian Patent Act1.11 Drugs Price Control Order (DPCO)1.12 Bulk Drug Policy1.13 Quality and Pharma Industry1.14 Current Market Reflections (May 2023)
Chapter 2: Introduction to Supply Chain Management
2.1 History2.1.1 Background2.2 Definition of Supply Chain2.3 Driving Forces of Supply Chain2.4 Components of Supply Chain2.5 Supply Chain Integration2.5.1 Process of Supply Chain Integration2.6 Supply Chain Management Processes2.7 Objectives of Supply Chain Management

Chapter 3: Value Chain in Pharmaceutical Industry
3.1 Introduction to Value Chain3.2 Michael Porter’s Value Chain3.3 Value Activities—Primary and Support3.3.1 Primary Activities3.3.2 Support Activities3.4 Competitive Advantage & Sustainability3.4.1 Differentiation3.4.2 Capabilities3.4.3 Conclusion
Chapter 4: Supply Chain in the Pharmaceutical Industry
4.1 Supply Chain Components in the Pharmaceutical Industry4.1.1 Upward Integration4.1.2 Downward Integration4.2 Factors Driving Supply Chain Integration4.3 Supply Chain Strategy—Various Elements4.4 Supply Chain Framework4.5 Benefits of Supply Chain Integration4.5.1 Overall Cost Reduction is One of the Important Benefits of Supply Chain Integration. Cost Reduction is Achieved in the Following Ways4.5.2 Supply Chain Integration Also Positively Impacts Customer Satisfaction and Enhances Customer’s Responses Mainly Due to the Following4.6 Barriers to Supply Chain Integration
Part B: Inward Activities
Chapter 5: Demand Generation and Forecasting
5.1 Introduction5.2 Production Planning5.3 Forecasting5.4 Time Series Methods5.5 Causal Quantitative Model
Chapter 6: Inventory Management in the Pharma Industry
6.1 What is Inventory?6.1.1 Definition of Inventory6.2 Why Hold Inventories?6.3 Why Avoid Inventories?6.4 Concept of Decoupling6.5 Basic Inventory Model6.5.1 Need for Inventory Control6.5.2 Objectives of Inventory Control6.5.3 Factors Influencing Inventory6.5.4 Impact on Profitability6.5.5 Types of Inventories6.6 Inventory Costs6.6.1 Introduction6.6.2 Ordering Costs6.6.3 Inventory Carrying Costs6.6.4 Understocking Cost (KU)6.6.5 Overstocking Cost (KO)6.7 Inventory Control Techniques6.8 Selective Inventory Control6.9 Inventory Norms and Replenishment6.10 JIT – Just in Time6.11 Vendor Managed Inventory
Chapter 7: Procurement in Pharma
7.1 Purchasing Function7.1.1 Objectives and Scope7.1.2 Responsibilities7.1.3 Place of the Purchase Function in Management7.1.4 Purchasing Policy and Procedure7.2 Planning for Purchase7.2.1 The Plans – Product Related Materials7.2.2 The Plans – Non-Product Related Materials7.3 The Purchasing Cycle7.3.1 The Purchase Requisition7.3.2 Purchase Enquiry7.3.3 Quotations and Comparison7.3.4 Purchase Order7.3.5 Supply7.4 Purchasing Organization7.4.1 Organization – Centralized/De-Centralized7.4.2 People7.4.3 Training and Development7.5 The 8 Rights Principle of Purchase7.5.1 Right Quality7.5.2 Right Quantity and Time7.5.3 Right Source/Vendor7.5.4 Right Price
7.6 Strategic Procurement or Purchasing Strategies
7.6.1 Traditional Classification7.6.2 External Factors7.6.3 Supply Positioning Classification7.6.4 Primary Materials7.6.5 Money Matters – Foreign Exchange7.7 Vendor Perception Model7.8 Purchasing Machinery/Capital Equipment and Spares7.8.1 Purchasing Machinery7.9 Purchasing Services7.9.1 Services7.9.2 Service Procurement Contracts7.9.3 A Comparison Between Procurement of Services and Procurement of Materials7.10 Purchasing Negotiations7.10.1 Introduction7.10.2 Negotiations: Why7.10.3 Negotiations: When7.10.4 Negotiation: Objectives7.10.5 Negotiation: Planning7.10.6 Negotiation: Organization7.10.7 Price Negotiations:7.10.8 Negotiations - Process7.10.9 Negotiating Strategy and Tactics7.10.10 The Negotiation Process7.10.11 Personal Ability and Qualifications of a Good Negotiator7.10.12 Cross-Functional Buying7.11 Purchase Order7.11.1 Contracts7.11.2 Purchase Order – A Legal Document7.11.3 Essential of a Purchase Order7.11.4 Format and Distribution of Copies7.11.5 Supplier’s Acceptance of Order7.12 Purchasing Performance Evaluation7.13 Enviro-Conscious Purchasing/Sustainable Purchasing
Chapter 8: Vendor Development/Management
8.1 Development8.2 Supplier Relationship Management
Chapter 9: Warehousing in Pharma Industry
9.1 Introduction9.2 Receiving9.3 Storage9.4 Issues9.5 Stores Organization9.6 Stores Relationships9.7 MROS Stores9.8 Finished Goods Warehouse
Chapter 10: Procurement of Capital Equipment and Spares
10.1 Purchasing Machinery10.2 Purchasing Spare Parts10.2.1 The Maintenance Contract10.3 Disposal of Old Machinery
Part C: Operational Activities
Chapter 11: Supply Chain Planning and Strategies
11.1 Introduction to Topic11.2 Definition and Introduction11.3 Supply Chain—Strategy11.4 Elements of Supply Chain Strategy11.4.1 Demand Flow Strategy11.4.2 Customer Service Strategy11.4.3 Collaboration Strategy11.4.4 Information Technology Strategy
Chapter 12: Order Processing and Fulfillment
12.1 Basic Concept12.2 Strategic Process12.3 Operational Process12.4 Responsiveness in Order Fulfillment12.5 IT Systems in Order Fulfillment
Chapter 13: Transportation Strategy in Supply Chain
13.1 Role of Transportation in Supply Chain13.2 Role of Transportation in Logistics13.3 Selection Criteria of Transportation Modes13.4 Characteristics of Different Transportation Modes13.5 Transportation Network Design13.6 Trade-Off Between Transportation and Inventory Costs
Chapter 14: Good Manufacturing Practices
14.1 What are Good Manufacturing Practices? (GMP)14.1.1 What is Quality Assurance (QA)?14.1.2 What is Quality Control (QC)?14.2 Overview of Pharmaceutical GMP Requirements14.3 GMP and Pharmaceutical Supply Chain Management14.3.1 Supplier Development—Identification, Evaluation and Qualification14.3.2 Quality Agreements/Contracts14.3.3 Manufacture and Controls of Products14.3.4 Storage, Transport and Distribution of Products14.3.5 Dealing with Counterfeit Medicines, Serialization, Track and Trace Regulations14.3.6 Handling of Complaints, Quality Defects and Recalls14.3.7 Quality Risk Management (QRM)
Chapter 15: Regulatory Requirements in Pharmaceutical Industry 265
15.1 Overview of Regulatory Requirements in the Pharmaceutical Industry15.2 Key Regulations Relevant to Supply Chain Management15.2.1 Good Distribution Practices (GDP)15.2.2 Directorate General of Foreign Trade (DGFT), India: Authentication, Track and Trace Requirements15.2.3 US Drug Supply Chain Security Act (DSCSA), November 201315.2.4 European Falsified Medicines Directive (FMD)15.2.5 Contract Manufacturing Arrangements for Drugs: Quality Agreements—US FDA Guidance for Industry, November 201615.3 Product Registration15.4 Post-Approval Changes and Life Cycle Management
Part D: Forward Activities
Preamble
Preface
Chapter 16: Introduction to Logistics and Distribution
16.1 Introduction to Distribution16.2 Historical Perspective16.3 Importance of Logistics and Distribution16.4 Functions and Responsibility of Distribution16.4.1 Scope of Physical Distribution16.4.2 Conflicting Objectives of Physical Distribution16.5 Typical Supply Chain Structure16.5.1 Structure of the Physical Distribution System16.5.2 Role of Logistics in Supply Chain Management16.5.3 Role and Importance of Supply Chains16.5.4 Structure of a Supply Chain and the Factors That Affect Its Design16.5.5 Ways to Integrate Logistics Along with the Supply Chain16.5.6 Benefits of Integrated Logistics Within an Organization16.5.7 Importance of Location Decisions16.5.8 Methods for Finding the Best Location for Distribution Centre16.6 Reimbursement Model Vs Supply Chain Structure
Chapter 17: Primary Distribution
17.1 Definition17.2 Central Warehousing Agent17.3 Inventory Management and Accounting17.3.1 What is Inventory?17.3.2 Definition of Inventory17.3.3 Inventory Challenge17.3.4 Inventory-Related Terms and Concepts17.3.5 Major Kinds of Inventories17.3.6 Inventory as Balance Sheet Items/Inventories are Relatively Liquid Assets17.3.7 Methods of Inventory Valuation for Reporting Purposes17.3.8 How Do Organizations Update Inventory Values?17.3.9 FIFO and LEFO: How Do They Differ?17.3.10 How Does Inventory Lose Value?17.3.11 Inventory Write-Offs are Usually Not Extraordinary Items17.3.12 Method of Calculating Inventory Turns17.3.13 Important Objectives of Inventory Management17.3.14 Physical Counting of Inventory17.3.15 Why is Physical Counting/Inspection Necessary?17.3.16 Various Methods Followed in Pharma Industry for Counting/Inspection of Physical Stock
Chapter 18: Secondary Distribution
18.1 Introduction18.2 Role and Responsibility of CFA18.2.1 Introduction18.2.2 Concept of CFA18.2.3 Difference Between Carrying and Forwarding Agent and Central Warehouse Agent18.2.4 Role and Responsibility of the CFA18.2.5 Methods Adopted By Pharmaceutical Organizations as Regards CFA Commission18.2.6 Security for Goods Stored in CFA Warehouse18.3 Consignee Agent Role/Responsibility18.3.1 Definition18.3.2 The Differences Between Consignee and CFA are Given in Table 18.218.3.3 Role and Responsibility of the Consignee Agent18.4 Super Stockiest/Stockiest Role and Responsibility18.4.1 Introduction18.4.2 Definition18.4.3 Super Stockiest18.4.4 Role and Responsibility of the Super Stockiest18.4.5 Role and Responsibility of the Stockiest18.4.6 Differences Between Super Stockiest and Stockiest are Given in Table 18.318.5 Retailer/Retail Chain/E-Pharmacy/Institutional Sales18.5.1 Introduction18.5.2 Retail Chain/E-Pharmacy18.5.3 Organized Pharma Retailing18.5.4 E-Pharmacy18.5.5 Institutional Sales
Chapter 19: Good Warehousing Practices
19.1 Warehousing Activity19.2 Warehousing and Carrying and Forwarding Agent19.3 Premises, Facilities and Storage Areas19.4 Temperature, Environment and Stock Control19.4.1 Normal Storage Conditions19.4.2 Defined Storage Conditions19.4.3 Monitoring Storage Conditions19.4.4 Storage Requirements—Documentation: Written Instructions and Records19.5 Control of Obsolete and Outdated Pharmaceutical Products19.5.1 Returned Goods19.5.2 Dispatch and Transport19.5.3 Product Recall19.6 Other Points in Relation to Good Warehousing Practices
Chapter 20: Transportation of Pharmaceutical Products
20.1 Introduction20.2 Guidelines for Transportation of Pharmaceutical Products20.3 Good Transportation Practices (GTP)20.3.1 Introduction20.3.2 Pharmaceutical Transportation20.3.3 Importance of Good Transportation Practices (GTP)20.3.4 Transport Risk Assessment20.3.5 Transport Validation20.3.6 Storage Conditions20.3.7 Calibration of Temperature Measurement Devices20.3.8 Support from Manufacturer20.3.9 Essential Elements of Good Transportation Practices (GTP)20.3.10 Conclusion20.4 Temperature-Controlled Transport Operation20.4.1 Introduction20.4.2 Refrigerated Vehicles–Temperature-Controlled20.4.3 Temperature-Modified Vehicles20.4.4 Passive Shipping Systems20.4.5 Active Transportation Systems for Air Transport20.4.6 Managing Refrigerated Road Shipments20.4.7 Pre-shipment/Dispatch Day Actions Listed Below are Based on Risk Mitigation Principles:20.4.8 Introduction to Air Transport
Chapter 21: Reverse Logistics in Pharmaceutical
21.1 Introduction21.2 Reverse Logistics in the Pharmaceutical Industry21.2.1 Findings and Conclusion21.3 Current Scenario in Handling Reverse Logistics in India21.3.1 Reverse Logistics: Importance and Difference21.3.2 Drivers of Reverse Logistics21.3.3 Simplification of the Reverse Logistics Process21.4 Standard Procedure for Destruction/Incineration21.4.1 Procedure for Destruction21.4.2 Product Recalls21.4.3 Returned Products21.4.4 Counterfeit Pharmaceutical Products21.4.5 Importance of Metrics21.4.6 Conclusion21.5 Case Study
Chapter 22: Role of Trade Bodies in Pharma
22.1 Organization of Pharmaceutical Producers of India (OPPI)22.2 Indian Drug Manufacturers’ Association (IDMA)22.3 All India Organization of Chemist and Druggist (AIOCD)
Chapter 23: Goods and Service Tax (GST)
23.1 What is GST?23.2 What Will be Its Effects on India’s Pharmaceutical Industry?23.3 The Government Restored Confidence of India’s Pharmaceutical Industry By Implementing GST23.4 FAQs Relating to GST: Drugs and Pharmaceuticals23.5 What is E-Way Bill and Who Needs to Carry It?23.6 Five Things to be Noted in Connection with E-Way Bill Under the GST Regime and How It Works23.7 GST May Eliminate C&F Agents in Pharma Distribution
Chapter 24: Three PL and Four PL
24.1 Introduction24.2 What is 3PL?24.3 What is 4PL?24.4 Definition24.5 Services Provided24.6 Differences Between 3PL and 4PL Company
Part E: Related Topics
Chapter 25: Online Sales in Pharmaceutical Industry
25.1 Introduction25.2 Impact of Online Sales on Customer Service25.3 Impact of Online Sales on Cost25.4 Indian Pharma Sector and Online Sales
Chapter 26: Total Cost Approach in Distribution
26.1 Introduction26.2 Different Components of Total Cost Approach26.3 Conclusion
Chapter 27: Financial Aspects in Supply Chain
27.1 Working Capital Management27.2 Current Assets27.3 Relevance27.4 Inventory Reduction27.5 Orders to Cash Cycle27.6 Sales–Cost Savings27.7 Impact of Profitability–Reduction in Material Cost27.8 Return on Assets27.9 Relevance of Finance in the Supply Chain
Chapter 28: Outsourcing in the Pharmaceutical Industry
28.1 Outsourcing in Pharma Industry28.2 Definition28.3 Reasons for Outsourcing28.4 Strategic Reasons28.5 Tactical Reasons28.6 Decision-Making for Outsourcing28.7 Issues in Outsourcing in the Pharma Industry28.8 Areas of Outsourcing28.9 Advantages and Disadvantages28.10 Outsourcing Practices28.10.1 (A) Vendor Managed Inventory28.10.2 (B) Loan License and Third Party (LL and TP) Manufacturing Practice
Chapter 29: Global Supply Chain
29.1 Globalization29.2 Economic Globalization29.3 International Supply Chains29.4 Impact of Globalization29.5 Global Supply Chain29.6 Competitive Advantages29.7 Global Supply Chain Management29.8 Supply Management29.9 Global Supply Chain Strategy29.10 Global Sourcing29.11 How to Manage Global Sourcing and Procurement29.12 The Global Sourcing Process
Chapter 30: Imports
30.1 What Import Means?30.2 Import Procedure30.3 Customs Valuation30.4 Valuation Factors30.5 Non-Dutiable Factors30.6 Import and Registration30.7 Grant of Registration Certificate30.8 Import Export Code (IEC)30.9 HSN Interpretation—Harmonic System Nomenclature30.10 General Rules for the Interpretation of the Harmonized System30.11 Common Pitfalls with Importing and Exporting
Chapter 31: International Trade
31.1 Glossary of International Trade – Terms31.2 What Does Export All Mean?31.3 Advantages and Disadvantages of Exporting31.4 India’s Export Scenario31.5 Steps to Export Pharmaceutical Products31.6 Goods Readiness and Documentation31.7 Goods Removal from Works31.8 Documents for Clearing and Forwarding Agent31.9 Customs Clearance EDI31.10 Arrival of Goods At Docks31.11 Let Export Order31.12 Loading of Goods31.13 What are the Key Problems of India’s Export Sector?31.14 PIT Falls to Avoid31.15 Export Incentives
Chapter 32: Information Technology in Pharma Supply Chain
32.1 Introduction32.1.1 Importance of Information Flow in Supply Chain32.2 Use of Information in Pharma Industry – Supply Chain32.3 IT Solution in Supply Chain32.3.1 EDI (Electronic Data Interchange)32.3.2 Internet Technologies (Intranet, Extranet and e-Business)32.4 Enterprise Resource Planning (ERP)
Chapter 33: Cold Chain Pharmaceutical Products
33.1 Introduction33.2 What are Cold Chain Medicines?33.3 Temperature Monitoring33.4 Packing for Despatch33.5 Transportation33.6 Preventive Maintenance33.7 Contingency Plan33.8 Excursion Handling
Chapter 34: Supply Chain Performance Measure
34.1 Concept of Performance Measure34.2 Definition of Performance Measure34.3 Performance Measurement in Supply Chain34.4 Procurement Performance34.5 Vendors Performance34.6 Inventory Performance34.7 Manufacturing/Operations Performance34.8 Distribution Performance
Chapter 35: Supply Chain Issues and Challenges in Pharmaceutical Industry
35.1 Introduction35.2 Responsive Supply Chain Systems and Its Characteristics35.3 Major Transformation35.4 Strategic and Competitive Areas35.5 Challenges to be Addressed By Supply Chain Managers:35.5.1 Sustainability in Supply Chains35.5.2 Outsourcing35.5.3 Vulnerability35.5.4 Collaboration35.5.5 Search for Talents35.5.6 Coping with Supply Chain networks35.5.7 Mindset – Whole as an Enterprise35.5.8 Innovation
Chapter 36: Critical Success Factors in Supply Chain in Pharmaceutical Industry
36.1 Introduction36.1.1 Critical Success Factors and Controls36.2 Critical Success Factors in Supply Chain Management of Pharma Industry36.2.1 Leadership and Integrity36.2.2 Network of Good Supplies36.2.3 Inventory Management36.2.4 Cost Reduction36.2.5 Market Knowledge and Update36.2.6 Understanding Customer Requirement36.2.7 Distribution and Services36.2.8 Cycle Time and Automation
Best Supply Chain Quotes
References
Annexures
Bibliography
Index
Copyright