THE BASICS OF A QMS

FOR PV PROCESSES

May 21st, 2021

QUALITY MANAGEMENT SYSTEM

 Module I of GVP refers to ISO 9001

▪ Responsibility, involvement of the top management
▪ Quality policy
▪ Setting up and availibility of the adequate resources
▪ Implementation of a QMS
▪ Continuous improvement of the processes
▪ Implication of the QPPV

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HUMAN RESOURCES

 Job descriptions:
▪ Describing the tasks and responsibilities, up to date, with qualifications pre-requisite defined for the position,
hierarchical/functional link defined, dated and signed
▪ CV dated and signed
 Training:
▪ Specific PV training
▪ Initial and continue (every year or 2),
▪ Tailored training plan for each functions, including tasks, organisation, products, SOP, tools, …
▪ Traceability = tracking tools, indicators …
 Qualification procedure:
▪ Relevant test – qualifying rating
▪ Requalification process for those who have been absent in an extended period of time to be defined
▪ SOP and tracking tools

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QUALIFIED PERSON FOR PHARMACOVIGILANCE

 Each pharmacovigilance system can have only one QPPV

 The QPPV shall reside and operate in the EU
 Level of oversight and possibility of intervention on the PV system, the QMS applied to the PV and
the risk management system
 Contact detailed submitted to the authorities (contact person in case of inspection)
 Reachable at any time – backup system in place and documented
 Qualified - the QPPV is assisted by a medically trained person where appropriate
 Position in the organisation allowing demonstrably (evidence) to:
▪ Intervene on the compliance system
▪ Intervene on the decisions on the B/R balance
▪ Signature of PBRER, Protocole PASS
▪ Acess to the PSMF - regulatory compliance indicators

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QUALITY DOCUMENTATION

 The “must have” SOP:

▪ Management of the documentary system and archiving
▪ Initial and continuous training of the staff
▪ Process of contractualisation
▪ System for the management of deviations and non-compliances
▪ System of internal and external audits
▪ Preparation and update of the PSMF
▪ Management of the documents of the products information
▪ Collection and management of PV data (with FU process)
▪ Management of medical information during and outside working hours
▪ Surveillance of internet interfaces and social media
▪ Process of detection and management of signals
▪ Preparation and update of RMP
▪ Business continuity services for the collection of PV data

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KEY PERFORMANCES INDICATORS

 Monitoring method - targets for the performance - measuring frequency

 Measurement of the performance of the submission of:
▪ Safety variations (internal and external deadlines)
▪ ICSR
▪ PSUR
 Measurement of the quality of submitted:
▪ ICSR
▪ PSUR
 Evaluation of the effectiveness of additional risk minimisation measures and commitments
related to the MA
 Any other KPI which evaluates the performance of the PV system

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PV AUDITS AND THE RISK-BASED APPROACH

Audit Planning - Strategic level

• Should describe how the audit activities will be delivered over a period of time: the postulates based on a risk approach
on which the audits program is based, the processes that should be subject to an audit, the topics to be audited, the
Risks assessment (2 to 5 years)
methods and assumptions (i.e. risk assessment) applied. Upper management should be involved.

Audit Planning - Tactical level

• Should define the processes and activities of the PV system that should be audited, the objectives of the audits and the
scope of the audits (duration, location, periodicity, …). The QPPV ensure that the program meets the objective. Capacity Audits programme (1 year)
for follow-up audits should be foreseen in the audit programme.

Audit Planning - Operational level

• Should plan the individual audit engagements, prioritising audit tasks based on risk and utilising risk-based sampling and Audit plan (1 to 3 days)
testing approaches

Audit execution – Reporting

• Should be signed by the auditor and forwarded to the QPPV – classification of deviations according to the definitions of Audit report
module IV of the GVP

Audit Follow-up – CAPA

• Should be defined by the QPPV & the auditee. The QPPV should monitor the CAPA plan until closing. The evidence of CAPA plan
the CAPA resolution should be recorded

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MANAGEMENT OF CONTRACTS WITH PARTNERS AND SERVICE PROVIDERS

 Control of these actors who carry all or part of the system / activities of PV and activities
impacting the PV – involvement of the QPPV as soon as there is a project for a contract
 Interface legal service – PV: secure – reconciliation of contracts / SDEA
 Pre-selection process & Qualification process
 Full list of all contracts available
 PV staff informed ++: deadlines to be respected in particular for the exchange of safety
data > impact on local compliance
 Signed contracts, practical description of tasks outsourced with deadlines, PV
requirements in accordance with the regulations for the activity outsourced, quality aspect
and training of the provider / partner covered with means of verification by the ordering
party = you

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MANAGEMENT OF THE INTERFACES WITH PV

 Objective > describe, train, reconcile, verify and … control !

 Marketing Department:
 Control of the data collected via marketing studies, social media, and other
 Legal Department:
 Partners and subcontractors’ contracts: formats, clinical studies contracts (CRO) and
observational studies
 Medical information :
 PV case « hidden » behind a question
 Quality Complaint:
 Mixed cases, inefficacy
 Trends and recurrences: signal detection > inform the QPPV

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PHARMACOVIGILANCE SYSTEM MASTER FILE

 Description of the current PV system used by MAH regarding its product portfolio
 Primary Source of Major Findings
▪ Document not referenced in the system
▪ Insufficiently detailed activities (only a reference to the SOPs)
▪ Insufficient PV case sources (missing the complaints, the medical information, the EMA)
▪ No description of the risk-based audit strategy and process timelines
▪ Critical and major deviations in progress not listed in annex
▪ No date of application of the procedures in Annex E
▪ KPI missing
▪ LPPVs’ (subsidiaries + partners), subcontractors’ contacts (names, phone numbers and e-mails) insufficiently
detailed
▪ Missing status of the products
▪ Market research, patient-oriented programs not included in the Annex

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FOR MORE INFORMATION
CONTACT US

Laurence Richard
Head of Development &
Operations
Senior Quality Auditor
lrichard@productlife-group.com
www.productlife-group.com

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