giqar 20 giugno stagi - ssfa.it · - management of psur - corrective and preventive actions -...

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Quality in pharmacovigilance systems

June 20th, 2014

Lisa Stagi, Medical Compliance Leader Roche Spa

ü Regulation 1235/2010 e Directive 2010/84Legal basis

ü Regulation 520/2012Minimum requirements for quality systems for carrying out the pharmacovigilance activities

ü GVP Modulo IPV Systems and their Quality Systems

Quality systems in pharmacovigilance: legal requirements

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Quality systems in pharmacovigilance: legal requirements

Consistency with principles in ISO standards

ISO 9000 standard for quality management systems implementationdefines:

- How an organization manages process in a quality framework- How to manage compliance to defined requirements- How to manage customer satisfaction- A set to aim at continuous improvement (ISO 9004)

“What is quality and quality management system?”

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Definition of Quality Management

“Quality is:

The degree to which a set of inherent characteristics fulfills requirements”According to the ISO 9000 standard

“A Quality Management system is defined as:

The organizational structure, responsibilities, procedures, processes

and resources for implementing quality management”According to US FDA 21 CFR 820

Definition of Quality Management System (QMS)

Framework and mindset at same time

• It is a framework that sets out the structure, responsibilities and procedures that help us identify, measure, control and enhance core business processes • The goal of a QMS is to maintain compliance and improve business performance. • It is composed by different elements interconnected

“QMS is the difference between excellence and disaster”

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A mature GVP QMS includes 5 elements...

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Implemented both at a Global level and at Affiliate level

Communication links between Global and local functions

The cycle assures continuous improvement

QMS Framework Strategy & Governance Strategic direction and principles that demonstrates Roche’s commitment to operate in a compliant way and is dedicated to continuous improvement

Organisational EffectivenessOrganisation that is structured in a clear way and is well resourced with people that are capable and trained to perform their activities

Processes and ProceduresPolicies, SOPs, work instructions, processes and training materials that enables the business to be correctly skilled and compliant

RecordsObjective evidence and associated network of IT systems, documentation and tools to collect, process, manage and store all data associated with GCP/GVP

Continuous ImprovementProcess by which Roche continually improves the effectiveness of our procedures and overarching QMS

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Practical examples of QMS in GVP

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QMS Core Documents QMS Components

GCP/ GVP QMS Manual

• The fundamental document that summarises the content of the QMS framework

GCP/ GVP Quality Plan

• Operational tool designed to oversee the implementation of the Quality Manual (updated annually)

• Clearly defined roles, job descriptions and training documented for all individuals

• Standardized and simplified processes and SOPs across the organisation

• GVP documents stored in structured and easily accessible compliant systems

• Opportunities for improvement are

& targets (KPI management and monitoring)

• Opportunities for improvement are identified through regular review of metrics & targets (KPI management and monitoring)

• Regular management reviews to assess Quality performance

Strategy & Governance

Organisation Effectiveness

Processes & Procedures

Record

Continuous Improvement


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QMS Components

Regular management reviews to assess Quality System performance in order to provide management with adequate information

Periodic assignment and review of quality objectives

Governance model maps and charters

Strategy & Governance

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QMS Components

Clearly defined roles, job descriptions and training documented for all individuals- QPPV with sufficient authority to affect the operation in thequality system and the activity of pharmacovigilance- organization chart and clear definition of roles and responsibilities (function in charge of PV system implementation and oversight, execution, audit activities)- job descriptions with description of main role responsibilities, including QPPV - defined procedures to be followed in case of emergency (back up)



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QMS Components

Clearly defined roles, job descriptions and training documented for all individuals- staff competent, qualified and trained, (documented way) including QPPV - initial and continuing training, documented - reliable and updated training records- Training efficacy


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QMS Components

The marketing authorization holder has the responsibility to ensure that in relation to outsourced activities is applied to an effective system of quality

à importance of procedures on vendors management and vendor continuous oversight, in order to assure a fully compliant system:

- Pharmacovigilance agreements in place- KPI defined to have oversight of vendor activities- Audit plan



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QMS Components

Standardized and simplified processes and SOPs across the organization- continuous monitoring of pharmacovigilance data - Risk minimization and risk prevention, managing new risks or changes to existing risks - the scientific assessment of the risks of medicines - transmission to the EudraVigilance database of accurate and verifiable dataon serious and non-serious adverse reactions, according to the timing defined by regulation- SOPs to guarantee the quality, integrity and completeness of the information provided on risks of medicines - To avoid double reporting - For validation of the signals


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QMS Components

Standardized and simplified processes and SOPs across the organization

- effective communication with the competent Authorities- Business Continuity Plan- Managing the PSFM - Management of PSUR - Corrective and preventive actions - Post-authorization safety studies - the updating of product information - Safety management during clinical trials- Adequate provision of information relevant to safety to health professionals and patients



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QMS Components

GCP / GVP documents are stored in structured and easily accessible compliant systems

- Recording all the information of PV, handled and stored in such a way they can be reported, interpreted and verified thoroughly - Pharmacovigilance data and documents relating to individual medicines authorized preserved as required - Records management system for all documents used for pharmacovigilance activities in order to: ü Find these documents ü Track how and when were examined / made decisions on safety

issues - Tracking and follow-up of adverse reaction reports - Keeping the elements of the PSFM according to law requirements

Record

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QMS Components

Opportunities for improvement are identified through regular review of metrics & targets (KPI management and monitoring)

Periodic review of Quality Plans

Implement Quality Monitoring (à routine sourvellaince of activities performed through Quality Control and Quality Assurance activities)



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QMS Components

Quality Control activities

- Double check activities and quality control plan for more relevant processes (IRT collection, RMP…)

- Monitoring of process performance through KPI, regularly collected and reviewed

-KPI identified based on the main attributes of processes (in terms of accuracy, consistency, completeness and medical adherence) à dashboarddeveloped to be considered by senior management.

- KPI out of control subject to CAPA (Corrective & Preventative) management


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QMS Components

Quality Assurance activities

Audit - Periodic audits based on risk and process analysis, with a defined audit planà to ensure compliance with quality system requirements described à to determine the effectiveness à outsourced activities covered by audit plan

- Audits carried out by people who do not have responsibility or implications à Independent auditors required (Quality Assurance function)

- Documented reports and follow up



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QMS Components

Quality Assurance activities

CAPA management

- Defined SOPs to track, manage and periodically review corrective and preventative actions, to be reported to senior management in management review

- Deviation management


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“Quality is not an act, it’s a habit”Aristotile

Mindset

AccountabilityProactive ThinkingCommitment

Quality owned by all

CapabilitiesSkillsKnowledge Experience EducationTraining

Leadership & business acumenQualified Staff

Compliancesustainability & proactive risk management

Our approach to QMSFully engrained quality in the organization

Systems & ProcessesGxP ProcessBusiness Process

Robust business processes & systems

Process capability/KPIs

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Most importantly: Keep it Simple !

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Grazie per l’attenzione