1. MAH Responsibilities and the Role of the QP
Ann McGee
Managing Director
Pharmalex Ireland
QP Forum
12th April 2018
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6. MAH Responsibilities and the Role of the QP
Who is the Marketing Authorisation Holder (MAH)?
The Company or other legal entity in whose name the Marketing Authorisation has been granted
Typically a legal entity with no organisational structure
Often the MAH is the Regulatory function of an affiliate
MAH responsibilities cannot be delegated. Activities can be delegated but still require oversight by the MAH
Role of QP??
Who takes responsibility for what?
How many MAHs have a structured QMS, for example a structured change management system?
What does all this mean?
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7. MAH Responsibilities and the Role of the QP
What is the level of QP in organisation?
Who do they report to?
Are they involved in decision making?
Have they got the required visibility?
Are they kept informed of MA variations?
Do they have input into significant change controls; new product introduction?
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8. MAH Responsibilities and the Role of the QP
1. Control of Clinical Trials / Studies (pre and post marketing
10. Control of responsible Marketing and Promotion
2. Oversight of manufacturing from API to QP release to market
9. Provision of Medical information
Legal Obligations of Marketing Authorisation Holder (EU)
Related activities may be delegated but responsibility is retained by MAH
3. QP Arrangements
8. Pharmacovigilance & QPPV
4. Control of Labelling and Packaging
5. Supply and Distribution
7. Complaints, Quality Defects and Recall
6. RP Arrangements
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9. MAH Responsibilities and the Role of the QP
Responsible for ethical clinical trial design and execution
1. Control of Clinical Trials / Studies (pre and post marketing
MAH
MAH
Clinical trials/studies must be managed in compliance with GCP
Considerations for the QP
What clinical trials is the organisation conducting?
QP review of batch record
Release of batch according to Annex 13
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10. MAH Responsibilities and the Role of the QP
Oversight of the supply chain to ensure medicinal products are manufactured and distributed in accordance with GMP and GDP and to ensure that falsified medicines are prevented from entering the supply chain
2. Oversight of manufacturing from API to QP release to market
MAH
EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
Annex 16: Certification by a Qualified Person and Batch Release
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11. MAH Responsibilities and the Role of the QP
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12. MAH Responsibilities and the Role of the QP
QP – review of the documented supply chain
How can the QP gain assurance?
Who are the stakeholders in supply chain?
What about physical transport considerations?
What about storage considerations?
What about product ownership?
What about financial transactions?
What about compliance status?
Knowledge of control of supply chain
Vendor qualification and management
Quality agreements with stakeholders
External audits
Change management
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13. MAH Responsibilities and the Role of the QP
Provision of a QP
QP as the eyes and ears of the MAH & structures to enable this to operate
3. QP Arrangements
MAH
Considerations
Multiple QPs in the chain
QP at a CMO
QP to QP agreements
How to ensure that Contract QPs are kept current?
Is the QP satisfied that they have connections with the right people – RP, QPPV?
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14. MAH Responsibilities and the Role of the QP
Must be current and correct
Liaison between MAH and manufacturing/batch release sites
Regular review of finished packs from batch release sites
4. Control of Labelling and Packaging
MAH
Incorrect labelling is the source of many product recalls
How is the QP kept up-to-date on current labelling?
Is QP involved in change management process?
Does the QP have a relationship with Regulatory Affairs?
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15. MAH Responsibilities and the Role of the QP
GDP requirements
Management and control of procuring, supply, distribution, storage, transportation
RP roles & responsibilities
5. Supply & Distribution
6. RP Arrangements
MAH
QP RP
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16. MAH Responsibilities and the Role of the QP
QPPV appointed by MAH
Involvement of PhV function?
Reporting requirements to authorities
7. Complaints, Quality Defects & Recall
8. Pharmacovigilance & QPPV
MAH
Relationships QP QP QP RP
QPPV QP
How are these relationships built and maintained?
What is the level of trust?
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17. MAH Responsibilities and the Role of the QP
Contracted activities
MAH must ensure an appropriate standard of quality and compliance exists at third party organisations
Activities may include:
Manufacturing & distribution
Logistics
Testing and QP release of manufactured product
Pharmacovigilance services
Regulatory affairs services
Management of safety information
Supply chain services
Contract clinical trial/GCP services
Representatives in local markets receiving and forwarding product quality complaints and ADR reports
Complaint coordination and investigation at contract manufacturing/distribution sites
Recall management at contract manufacturing/distribution sites
WHERE DOES THE QP COME INTO THIS??
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18. Ms. Ann McGee +353 1 846 4742 Ann.mcgee@pharmalex.com
Suite 2 Stafford House
Strand Road
Portmarnock
Co Dubllin
D13 H525
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19. Additional Information
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20. 9. Provision of Medical Information
Medical Information function
Establish a scientific service to compile and collate all information relating to product
9. Provision of Medical Information
MAH
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21. 10. Control of responsible Marketing & Promotion
Back-up slide
Activities to be conducted in compliance with IPHA Code of Practice and SI541 (Control of Advertising)
Training in these codes/regulations required for relevant personnel
MAH
10. Control of responsible Marketing & Promotion
Promotional materials
Procedures to manage development, approval, distribution, update
Ensure only current promotional materials and SmPCs are provided to HCPs
MAH
MAH
Management and control of free medical samples
Training for Sales Reps regarding product information, complaint and adverse reactions report handling
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