the role of the qp in ma compliance - hpra
TRANSCRIPT
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The Role of the QP in MA Compliance
Breda Gleeson, Market Compliance Inspector
IMB GMP & Market Compliance Information DayDublin, October 14th, 2010
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Objectives
• Outline the responsibilities of the QP in MA Compliance
• Convey the importance for the QP to have assurance in MAH systems and processes
• Provide guidance on how best the QP can gain such assurance
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Legal Requirements
• Medicinal Products (Control of Manufacture) Regulations, S.I. No.539 of 2007
Article 13(3)(a) - The function of the qualified person is to ensure that every batch of medicinal product is manufactured and checked in compliance with the provisions of the marketing authorisation
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Certification of MA Compliance
• Basic arrangements for batch release defined by the MA
• MAH responsible for maintaining MA in line with technical and scientific progress• MAH office or global regulatory office with
local representation • May or may not be part of the same
corporation as the manufacturer• Often based in location separate to the site of
manufacture
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Certification of MA Compliance
• QP required to rely in part on the MAH• Third party reliance should be well founded
• Reliance based upon• Controls in place at the MAH for assuring
regulatory compliance• Quality management system supporting those
controls and activities
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How can the QP gain assurance?
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QP Assurance
Knowledge of MAH Systems and Procedures
Compliance Checks
Technical Agreement
Product Quality Review
Audit of MAH Office
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Knowledge of MAH Systems and Procedures
• MAH should have a well defined quality management system• All activities pertaining to the maintenance of MAs
controlled by the QMS
• Evidence of effectiveness
• Appropriate oversight of the quality system• Self-inspection programme• Competent Authority inspections
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Considerations…….
• How is registered product information managed and controlled by the MAH?
• How are regulatory commitments and regulatory changes managed, tracked and implemented?
• How are commitments and changes communicated to the manufacturing site?
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Considerations…….
• At what point in the process are commitments and changes communicated to the manufacturing site?
• What documentation is provided to the QP to support batch certification / release activities, and how is this generated and controlled?
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Compliance Checks
• Verification of compliance status and identification of system / process gaps at MAH Office
• Sample size and frequency of checks dependent upon• Number of MAs held by MAH• Major changes in MAH systems or processes• Compliance history
• Checks should be documentedSlide 10
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Technical Agreement
• Important to have well defined and documented division of responsibilities
• Consideration given to the inclusion of the following responsibilities:• Communication of regulatory commitments and
changes to the manufacturing site • Tracking regulatory changes and commitments
and ensuring their implementation within the agreed timeframe
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Technical Agreement
• Generation and updating regulatory information file in use at manufacturing facility
• Co-ordinating quality defect / adverse reaction investigations and recall actions
• Reporting quality defects to Competent Authorities• Generation and review of PQRs• Management of stability programme• Provision for audits• Requirement for MAH to notify QP of serious
systematic failures
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PQRs
• Verify compliance and identify MA non-compliance trends via the review of • MA variations submitted, granted and refused• Changes carried out to the processes or analytical
methods• Quality related returns, complaints and recalls• Post-marketing commitments• TAs
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Audit of MAH Office
• Invaluable means of assessing the effectiveness of systems and procedures
• Not a formal requirement, but strongly advisable if significant MA non-compliances identified
• Provision for audits included in TA
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IMBs Monitoring of MA Compliance
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Quality Defects & Recall Programme
GMP Inspections
MAH Inspections
Sampling & Analysis
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MA Non-compliance Case Study
• Q1 2010: IMB review performed on the compliance of package leaflets (PL) in a number of Irish marketed anti-depressant products• Main finding - none of the required suicide
warnings included on the PL of two products
• Quality defect investigation triggered • Non-compliant batches recalled to pharmacy level • MA non-compliance issue more extensive• Company committed to a PL review of its entire
product portfolio Slide 16
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MA Non-compliance Case Study
• Q2 2010: PvG inspection at MAH office• No formal QMS in place• Procedure for processing regulatory changes
breached on several occasions• Severe difficulty in establishing current approved
documentation for some products
• IMB requested the voluntary suspension of QP certification / release of a number of products
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MA Non-compliance Case Study
• Q2 2010: Joint IMB / CA inspection of MAH office• Systems in place insufficient to ensure MA
compliance• Lack of confidence in compliance of products on
the marketplace• Review being performed by company was
insufficiently robustLack of detailed protocolChecks not adequately documented Lack of appropriate QA and QC
• Critical deficiency issued
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MA Non-compliance Case Study
• Company requested to • Suspend compliance review until detailed
procedure in place• Submit detailed investigation protocol for IMB / CA
approval• Extend review to include all artwork components
and CMC-type changes• Compliance review investigation report to be
submitted to IMB / CA
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MA Non-compliance Case Study
• Competent Authorities notified• Other Supervisory Authorities• Class II Rapid Alert issued
• Outcome of non-compliances• Number of products recalled across a number of
markets• Cessation of QP certification / release
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MA Non-compliance Case Study
• Current status of compliance review• Investigation protocol for artwork review approved
and company's review is ongoing• Investigation protocol for CMC review under
approval
• IMB / CA re-inspection of MAH office scheduled for Q4 2010
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Conclusion
• QP has a role in assuring MA compliance
• Should have in place a plan for obtaining and maintaining assurance in the MAH systems and procedures
• Should be able to verify that assurance is well founded
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Slide 23
Thank You