Compliance - The Blue Mountain Summit

Report
Compliance
From The
Ground Up
September 18, 2013
Earlene Gibbons
Director, Operational Technology
Unique Opportunity
• Green Field Construction
– Solid Dose Manufacturing
– 200,000 sq. ft. facility
– New Equipment
• Blank Slate
– No existing systems
– No in house experience
– No additional team members
• No formal budget allocated for GxP
systems
– However…
Zero to GxP in 8 Months
• 100% Outsourced Manufacturing to Insourced
Manufacturing
• Systems to support the facility, manufacturing,
and quality required identification,
procurement, installation and qualification
• The schedule of system installations had to be
prioritized and integrated into the construction
schedule
GxP Systems
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Building Management
Calibration Management
Maintenance Management
Document Management
ERP / Materials Management
QMS
LIMS / Chromatography Data
First Things First
• One of the first systems required to be
available for use was a calibration
management system
– Manufacturers’ Bench Calibrations
– Installation Calibrations
– Validation Calibrations
• The calibration management system
availability had to be closely coordinated
with the BMS startup and commissioning
Calibration
“Automatic, mechanical, or electronic equipment or
other types of equipment, including computers, or
related systems that will perform a function
satisfactorily, may be used in the manufacture,
processing, packing, and holding of a drug product.
If such equipment is so used, it shall be routinely
calibrated, inspected, or checked according to a
written program designed to assure proper
performance.
Written records of those calibration checks and
inspections shall be maintained.” CFR 211.68
Selection Requirements
System Requirements
Vendor Selection Criteria
Regulatory Compliant
Project Management Services
Part 11 Compliant
Implementation Services
Ease of Use
Training
Paperless
Understanding of Best Practices
Scalable
On–Going Support
Reporting (Standard & Ad Hoc)
Reputation
Configurable
Customer Service
Cal / PM Harmonization
Life Sciences Industry
Experience
Audit Trail
With
a little
help
from
our friends…
Startup & Commissioning
• Start up is the series of events required to
turn equipment or systems on for the first time
• Equipment Commissioning is the process of
testing equipment to verify it functions
according to the design specification
• Commissioning is performed under Good
Engineering Practice (GEP)
Validation / Qualification
• Installation Qualification documents that the
equipment was installed correctly:
– Design features
– Installation conditions
– Environmental conditions
– Calibration and PM schedules
– Safety features
– Software documentation
– Spare parts list
– Vendor documentation / Turn-over package
• Equipment Validation/ Qualification is documented
evidence that provides a high degree of assurance
that the equipment requirements and specifications
are met and will fulfill its intended purpose
RAM Implementation
• Project Planning
• Data Migration
– External Calibration Manager to RAM
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Validation
SOPs
Training
Go-Live
Master Data
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Accurate
Consistent
Secure
Scalable
Asset Management
Blue Mountain RAM is the system of record for
our equipment / asset management
• Types
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Equipment
System
Location
Personnel
Loop
• Classification
– Critical / Direct
– Non Critical / Indirect
Calibration
• A calibration management program ensures
equipment and instruments are calibrated
according to written instructions
• The calibration management program must
document the calibration date, person
performing the calibration and the date due of
the next calibration
• Calibration Periods
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Manufacturers Recommended intervals
Daily
Monthly
Quarterly
Semi Annually
Annually
After an event
Preventive Maintenance
• Preventive maintenance should be performed
at appropriate intervals to prevent equipment
malfunctions that are preventable with regular
monitoring
• PM activities include visual inspection of the
equipment, following the manufacturer’s
recommendations for routine maintenance
and regular inspection / replacement of parts
that routinely wear out or fail
Preventive Maintenance
• The equipment classifications identified and
assigned for calibration management provide
the foundation for the maintenance
management program.
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Unique Equipment Numbers
Preventive Maintenance Plans
Work Instructions (R3)
Historical Maintenance Records
Scheduling
Training
Spare Parts
Utilities
Quality Assurance
• Review and approve new and / or edited
records for equipment, instruments and
systems entered into RAM
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MDT
Standards
New Assets
Calibrations
PM
Val (upgrade)
SS (upgrade)
WPT (upgrade)
Day to Day Compliance
• Calibration and Preventive Maintenance
are required to maintain the equipment in
good working order
• Quality review of both calibration and PM
activities can be performed by exception –
reviewing only the records that are out of
tolerance
• Ease of reporting Calibration and
Maintenance activities provides regulatory
authorities / auditors with the documentation
of maintaining the equipment in compliance
with cGMP
Compliance
Compliance is not optional!
• Non-Compliant organizations risk
– Warning letters
– Delays in getting product to market
– Losing market share to competitors
Compliance is mandatory!
Corporate Compliance
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RTP upgrade to R3
Silver Spring upgrade CalMan to R3
Leveraged existing rules, workflows
Workflow Improvements
Integration with ERP and other corporate
systems
• Multi-Site Harmonization
Corporate Compliance
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Consistent Support Structure
Consistent approach to compliance
On-boarding New Facilities
Global Harmonization
References
• Code of Federal Regulations, Title
21, Part 210
– Current Good Manufacturing Practice in
Manufacturing Processing, Packing, or
Holding of Drugs
• Code of Federal Regulations, Title
21, Part 211
– Current Good Manufacturing Practice
for Finished Pharmaceuticals
• Blue Mountain RAM User Manual

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