Lean Management in the Pharmaceutical

Industry

Introduction of Pharmaceutical Industry The pharmaceutical industry discovers, develops, produces, and markets drugs

or pharmaceuticals for use as medications. Pharmaceutical companies may deal in generic or brand medications and medical devices.

The early days - Egyptians, Greeks, Arabs, China, India 1945–1970 The post-war years Further advances in anti-infective research Development and marketing of antihypertensive drugs Oral Contraceptives Mid 1800s-1945 From botanicals to the first synthetic drugs 1970-PresentTreatment of metabolic disorders Ventolin ,Lipitor (1997), Viagra ,Avandia ,Vioxx, Gleevec Search for gene therapies, stem cell-based therapies Stem-cell replacement of a trachea

Trend in Pharmaceutical Industry Many pharmaceutical manufacturers are following some of the lean

manufacturing principles in the way for significant improvement of operational efficiency and quality

Looking for ways to decrease risk and increase efficiency, transparency and collaboration in the supply chain

Pharma products will become more diverse

Lean

Lean History1995 TOYOTA PRODUCTION SYSTEM1979 QUALITY SYSTEM1983 NUMMI, SYCHRONONS MANUFACTURING1990 LEAN MANUFACTURING, ESENACH1995 DELPHI MANUFACTURING SYSTEM1996 GM-GMS1998 COMPETITIVE MANUFACTURING

Identify the value stream & eliminate waste & variationMake value flow at the pull of the customer

Involve, align & empower employees

Continuously improve knowledge in pursuit of excellence

Specify value

Identifying Waste Value-Added Work: Activities that transform material or information into drug that treat or prevent disease and relieve the patience’s pain

Non-Value Added Work: Excessive movement of products Batch records, samples or invalid test Cause of rework and corrections

Lean Tools

Lean House 5S Visual Controls Workstation Design Standard Work

Lean House

5S

5S implementation in Pharmaceutical IndustryGSK Australia implement 5s in Lab

Lab Bench Top Before 5S

Lab Bench Top After 5S

Visual Controls

A system of signs, information displays, layouts, material storage and handling tools, color-coding, and pokayoke or mistake proofing devices

A place for everything and everything in its place

Displaying key process indicators to process participants can react to real-time information

Visual Controls implementation in Pharmaceutical IndustryVisual Controls in GSK Australia Lab

Spaghetti Chart Visual Equipment Home Location

Visual Controls implementation in Pharmaceutical IndustryVisual Controls in GSK Australia Lab

Consumables Kanban Point of Use Consumables

More 5s+Visual Control Example

Use of Visual Management Boards and visual material controls in NVD labs

More 5s+Visual Control Example

Use of Kanban systems for storage of chemicals and materials in NVD labs

Workstation Design

Creating suitable work spaces based on the nature of the tasks involved Centrally locate shared services and support functions (e.g. sample

management / glass wash) Layout of workstation can support different shift patterns without loss of

efficiency

Standard Work

Every step in every operation is performed in a predictable manner

Standard work is already in situ, with Standard Operating Procedures (SOPs), manufacturing instructions, testing methods and validation protocols

Technical standards will be identified and fixed in line with regulatory requirements

Operational procedures, however, are often light on detail and as a result, variations in these may not be detected

Summary Pharmaceutical manufacturing process is more complicate than other

manufacturing industries

Pharmaceutical industry has failed to keep up with other industries in terms of manufacturing efficiency and productivity due to its high costs and burden involved in revalidating any process change

Effective lean management principles to be identified in the Pharma environment and utilized to improve the operational efficiency

Recommendation

Creating the right culture People involvement Visual controls Leadership standard work Sensei & Gamba walk Problem solving & rapid process improvement Systems Thinking Managing expectation

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