FDA “Guidance for Industry: Quality Systems Approach to

Report
Top Tactics for Maximizing GMP
Compliance in Blue Mountain RAM
Jake Jacanin, Regional Sales Manager
September 18, 2013
Presentation Objectives
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Convey importance of asset and event mgt
Communicate systems approach to asset mgt
Show broad scope and intricacies involved
How to meet national and international
regulations using Blue Mountain RAM
Presentation Overview
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Asset compliance definitions
Relevant regulatory observations and findings
Current compliance trends and observations
Compliant cGLP and cGMP asset mgt
Quality Systems approach to asset mgt
Top 10 GMP Deficiencies Categories
 Documentation of manufacturing and related
activities
 Design and maintenance of premises and systems
 Documentation availability and accessibility of
records
 Personnel training and qualifications
 Design and maintenance of equipment and systems
Top 10 GMP Deficiencies Categories
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Cleaning validation and testing
Equipment and process validation controls mgt
Product quality review
Supplier, contractor, vendor control and audit
Calibration of measuring and test equipment
Life Sciences Regulatory Trends
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Quality Systems inspections increased
Regulatory inspections increased significantly
Citations and violations increased significantly
Warning letters doubled over past several years
Relevant Definitions
 FDA Warning Letter
– Correspondence to company representative
– Noncompliance to regulatory standards (CFR’s)
 FDA Form 483
– Notice of inspectional observations identified
 Consent Decree
– Voluntary order or judgment between parties
Relevant Definitions
 Voluntary compliance
– Acknowledgment and corrective action
 Assets
– Equipment, instrument, system, location,
personnel
 Events
– Calibration, PM, validation, testing, NCR,
training, cleaning
 Quality System
– Personnel performing policies, practices,
procedures
FDA 483 Observations
Failure to:
 “Adequately establish procedures to ensure
equipment routinely calibrated, inspected &
maintained”
 “Follow preventive maintenance schedule outlined”
 “Maintain buildings in a good state of repair”
 “Validate a computer database used for a quality
function”
 “Have SOP’s ensure equipment routinely serviced”
 “Develop & maintain documentation of calibrations”
Systems Approach Example
Compliant Asset Management Process
Asset:
 Assessment: Purpose, role, worthiness
 Determination: Importance relative to product
 Induction: Approach, process and methodology
 Classification: Criticality and risk relative to product
 Specification: Service events and services required
Compliant Asset Management Process
Asset:
 Servicing: Depth, detail and frequency
 Coordination: Event forecast, schedule and
notification
 Personnel: Qualifications: Internal and external
 Preparation: Availability of standards, tools and
parts
 Procedure: Detailed direction for performing event
Compliant Asset Management Process
Asset:
 Reporting: Event outcome, status and availability
 Actions: Active, repair required, obsolete/ retire
 Recording: Means to record, document findings
 Labeling: Label generation based on asset status
 Deviations: Document and communicate findings
Compliant Asset Management Process
Asset:
 Review: Analyze and approve event results
 Recall: Next event generated automatically
 Changes: Role, parts, specifications, locations
 Approval: Review and approval of changes
 Measurement: KPI’s, metrics and analytics
Asset Induction
Specification Form – Manual Method
Who is Responsible to Specify?
Under a quality system, the technical experts who
have an understanding of pharmaceutical science,
risk factors, and manufacturing processes related
to the product, are responsible for defining specific
facility and equipment requirements1
1FDA
“Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP
Regulations”
Asset Classification - Criticality
Asset Criticality Assessment
 Evaluation of assets role in production of product
 Potential impact to Product, Process, Safety
 Collaborative process using qualified people
– e.g. Owner, Quality, Engineering, Metrology,
Maintenance
 GAMP Classifications
– Critical
– Non-critical
– No Impact
Asset Criticality Classification
 Identify and determine asset purpose and role
– HPLC monitors products purity
 Document assets classification and rational
– Asset is critical since it monitors product purity
 Process provides gains in productivity
 Perform with new and repurposed assets
Review and Approval
Under cGMP regulations, the quality unit (QU) has
the responsibility of reviewing and approving all
initial design criteria & procedures pertaining to
facilities & equipment & any subsequent changes
(§ 211.22c)
1FDA
“Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP
Regulations”
Personnel – Who is Qualified?
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Manage training for personnel and contractors
Recall and document periodic training events
Establish levels of required expertise “Crafts”
Specify and assign work by craft and expertise
Personnel Record
Vendor and Contractor Management
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Manage vendors and contractors
Document contact and contract info
Document and embed contracts and req’s
Document and maintain performance
Recall events for audit and contract review
Parts Inventory and Records
Job Plan
Work Event Scheduling
Specification e.g. – Calibration Data
Procedure: Detailed and Criteria
Labeling
CALIBRATION LABEL
ID: SPS-1
Cal Date: 02/ 06/2013
Due Date: 03/06/2013
Technician: JAJ
Asset Non-Conformance
Asset Event Deviation-NCR
Change Request and Review
Measurements and Metrics
Conclusion
 CFR Reg’s mandate compliant asset
management
 Scope is broad, intricate and challenging
 Quality Systems approach is required
 Systems approach increases success rate
 Agencies expect show and tell
 Blue Mountain RAM: Best solution to maintain an
asset’s compliance

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