Transcript Slide 1

Regulatory Compliant Performance
Improvement for Pharmaceutical Plants
AIChE New Jersey Section
01/13/2004
Murugan Govindasamy
Pfizer Inc.
Overview:
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Introduction
Significance of Regulatory compliance and guidelines
Automation Project – How to make it successful?
Downtime Monitoring
Conclusion
Discussion
Significance of
Regulatory Compliance and Guidelines
Regulatory Basis
Food, Drug & Cosmetic Act
Section 501(a)(2)(B) of the Food, Drug & Cosmetic Act
deems a drug product to be adulterated if :
“the methods used in, or the facilities or controls used for, its
manufacture, processing, packaging, or holding do not
conform to or are not operated or administered in conformity
with current Good Manufacturing Practice to assure that
such drug meets the requirements of this Act as to safety
and has the identity and strength and meets quality and
purity characteristics, which it purports or is represented to
possess.”
The Code of Federal Regulations (CFR) is a codification of
the general and permanent rules published in the Federal
Register by the Executive departments and agencies of the
Federal Government. Title 21 of the CFR is reserved for rules
of the Food and Drug Administration. Each title (or volume) of
the CFR is revised once each calendar year.
PART 211 - Current Good Manufacturing Practice for
Finished Pharmaceuticals – ‘the regulations in this part
contain the minimum current good manufacturing practice for
preparation of drug products for administration to humans or
animals.’
CGMP - Current Good Manufacturing Practice
REGULATORY
BASIS
FD&C ACT
1962
21 CFR
PART 320
21CFR
PART11
CLINICAL
STUDIES
21 CFR
11.10
21 CFR
211.68
COMPUTER
SYSTEMS
AUTOMATED
SYSTEMS
PROCESS
VALIDATION
21 CFR
PART 211
ANALYTICAL
METHOD
VALIDATION
CONTAMINATION
21CFR
PART 820
21 CFR 211
PROPOSED
AMMENDMENTS
QUALITY
SYSTEM
REGULATIONS
MEDICAL
DEVICES
TESTING
QC
RESPONSIBILITIES
Regulatory Guidelines:
Code of Regulation - General:
21CFR210 - Current Good Manufacturing Practice in
Manufacturing, Processing, Packing or Holding of Drugs:
General
21CFR211 - Current Good Manufacturing Practice for Finished
Pharmaceutical
Automation specific:
21CFR211 - 68 - Automatic, mechanical, and electronic
equipment
21CFR211 - 11 - Electronic Records; Electronic Signatures
--------------------------Guidelines:
GAMP4 - Good Automated Manufacturing Practice Guidelines
GAMP:
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Excellent tool for a project
Streamlines the requirements
Value adding activities
Common Language
Definitions
Validation
“Validation is defined as establishing documented evidence that
provides a high degree of assurance that a process, system,
equipment or assay will consistently produce the desired results
according to predetermined specifications and quality attributes.”
Qualification
“Qualification is defined as the documented evidence that the
equipment and systems will work correctly and consistently,
leading to expected results.”
V Model
USER REQUIREMENTS
SPECIFICATIONS
Verifies
FUNCTIONAL
SPECIFICATIONS
Verifies
DESIGN
SPECIFICATIONS
Verifies
SYSTEM BUILD, INSTALLED, &
CONFIGURED
PERFORMANCE
QUALIFICATION
OPERATIONAL
QUALIFICATION
INSTALLATION
QUALIFICATION
Validation Project Plan
- A Life Cycle Approach
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Pre-Qualification Process
Qualification/Validation Process – IQ, OQ & PQ
Commissioning/Implementation
System Maintenance
Change Control
Re-Validation Criteria
Retirement of the System
What to follow?
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GMP
Regulatory Documents
Regulatory Guidance
Industry Guidance
Internal Policies and Procedures
Quality People + Quality Process
= Quality Product
Automation Project
- How to make it successful?
Automation Projects
- Requirements for a successful project
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Clear Business Objective
Root Cause Analyzed, better than alternatives
Justified Investment
Well defined project plan
Champion to lead - from start to finish
Management Support
Major Objectives:
(Objectives which directly relates to the efficient
Manufacturing)
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Throughput Increase – Cycle time reduction, Capacity
Increase, High-speed
Quality Control / Improvement – Product Quality,
Compliance Requirement, Info. for decision making
Cost Control – Asset utilization, Efficiency Improvement,
Waste Reduction, COGS
Inventory Control – JIT, Scheduling, Push to Pull
EHS – Safety Requirement, Ergonomics
Specific – Product Launch, Process Optimization,
Information for Management
Automation Projects
- always good to…
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Avoid purchasing Serial #1 – Look for history
Know the alternatives and the consequences
Know the bottlenecks and pitfalls
Plan phased approach - if applicable
Enforce company standards and specifications wherever
possible. Alternate standards can be used if justified.
Select the suitable vendors who can establish long term
partnership
Select the most suitable hardware & software. They may
not be the best in the market
Automation Projects
- Watch out for…
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Scope creep – not a surprise in any automation project
Validation Issues – Good planning in the beginning will
avoid this
No user buy in - forced automation (typically an
automation engineer carries the project on his/her
shoulder).
No major objective (project - just for a sake of
automation)
Right solution or just a band aid?
"Do it right or do it twice."
Automation Projects
- Challenges…
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Return On Investment
Keeping up with technology
Validation Scope
Risk Assessment
Adopting to change (Automation)
Efficiency Improvement through
Downtime Monitoring
– a brief discussion
Downtime Monitoring
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Automatically capturing machine downtime and the
reasons for analysis
Key Performance Indicators (KPI)
Downtime monitoring – Excellent tool, good opportunity
for automation, success is measured on the use
Use: Problem solving through Root Cause Analysis
Can be scaled to fit
Utilization and Efficiency Improvement
- Business Model for performance tracking
Conclusion
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Understand the regulations
Follow the guidelines and Procedures
Plan Automation as a tool to improve a process
Design and qualification are key to success
Automation project is a success only when it ‘produces’
Discussion