FDA “Guidance for Industry: Quality Systems Approach to

Top Tactics for Maximizing GMP
Compliance in Blue Mountain RAM
Jake Jacanin, Regional Sales Manager
September 18, 2013
Presentation Objectives
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
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
 Design and maintenance of premises and systems
 Documentation availability and accessibility of
 Personnel training and qualifications
 Design and maintenance of equipment and systems
Top 10 GMP Deficiencies Categories
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
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,
 Events
– Calibration, PM, validation, testing, NCR,
training, cleaning
 Quality System
– Personnel performing policies, practices,
FDA 483 Observations
Failure to:
 “Adequately establish procedures to ensure
equipment routinely calibrated, inspected &
 “Follow preventive maintenance schedule outlined”
 “Maintain buildings in a good state of repair”
 “Validate a computer database used for a quality
 “Have SOP’s ensure equipment routinely serviced”
 “Develop & maintain documentation of calibrations”
Systems Approach Example
Compliant Asset Management Process
 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
 Servicing: Depth, detail and frequency
 Coordination: Event forecast, schedule and
 Personnel: Qualifications: Internal and external
 Preparation: Availability of standards, tools and
 Procedure: Detailed direction for performing event
Compliant Asset Management Process
 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
 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
“Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP
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,
 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)
“Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP
Personnel – Who is Qualified?
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
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
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
 CFR Reg’s mandate compliant asset
 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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