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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 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
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,
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”
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
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 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?
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
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