The quality system is a fundamental part of pharmacovigilance and is usually in charge of the quality assurance department. How to manage it if there isn’t a dedicated staff?

Dr. Marika Ciappa, Patient Safety & GVP Quality Lead of AstraZeneca Italia, spoke about it at the AFI “Pharmacovigilance and Quality Session” webinar, who shared the pharmacovigilance quality processes followed in her company reality.

She explains, in fact, that in the Italian branch of AstraZeneca there isn’t a real department dedicated to Quality Assurance, but all the quality processes are divided into the various functions of Good Pharmacovigilance Practice, Good Regulatory Practice, Good Clinical Practice, Good Manufacturing Practice and Good Distribution Practice. Together they contribute to consistently document the Quality Management System used to meet quality and compliance requirements and ensure continued product and process suitability.

Here’s how the process monitoring works.

Compliance with regulations

The regulatory references for the quality of pharmacovigilance are the GVP, in particular module I, and the European regulations and directives, that define the necessary requirements in a more practical way.
More precisely, in module I of the GvP the quality in the pharmacovigilance system is defined as the set of all the features of the system dedicated to producing results relevant to the objectives of pharmacovigilance. Quality can and must be measurable, a fundamental requirement to understand if the quality level has been achieved.
The quality system must be detailed in a manual where the policies and procedures are defined to ensure compliance with the requirements. Compliance must be monitored and can be done through KPIs (Key Performance Indicators).

Monitoring of the compliance of the Quality System

An essential element of a quality system applied to pharmacovigilance is the compliance; for its maintenance, there are some elements that cannot be missing:

  • Procedural system of SOP / WI: Operating instructions that detail the development of the process in-depth
  • Quality Manual of a subsidiary: in general or only for pharmacovigilance
  • Definition of roles and functions, above all of the staff belonging to the quality system
  • Training of staff related to the quality system
  • Management of external providers
  • Internal and external audit plan
  • Management of deviations and/non-compliance complaints
  • Process measurement through KPIs.

KPI analyses

The KPIs are also described in Module I of the GVP and in the implementing regulations of the European Commission as measures used to evaluate the processes of pharmacovigilance activity.

KPIs have several classifications:

  • General indicators, ie which measure the volume of the process. An example is the volume of cases sent to the parent company or to the Authority
  • Quality indicators: evaluate the quality of the process output, based on certain standards (eg relationship with an output model or customer satisfaction)
  • Cost indicators: they measure the resources consumed to arrive at a certain result
  • Service or time indicators: measure the response time from the start of the process to its conclusion. An example is medical information: a time KPI can analyze the average response time to requests.

The choice of KPIs must be carried out scrupulously, for this it will first be necessary to have well defined the pharmacovigilance processes and the related requirements. Then determine the variants and have the processes adjusted to meet the objectives. At this point it will be possible to equip oneself with all the tools useful for qualitative and quantitative measurements of the results that allow for the collection and analysis to be carried out in pre-established times. Last but not least, you must always be ready to change the indicators: it is possible that new needs may emerge during the use of the chosen ones.

Performance measurement

The KPIs can therefore be useful for measuring different types of performance, below are listed those that the speaker reported from her experience in the branch of the Anglo-Swedish giant:

  • Monthly monitoring (Quality control) of local processes.
    A few years ago an OPI (Local Operational Instruction) was introduced whose purpose is to ensure that company processes with an impact on Pharmacovigilance are managed in compliance with quality and compliance standards with regulations, with global and local SOPs and with the manual. of quality. It takes place through the compilation of documentation such as proceduralized Excel tables and sheets by the pharmacovigilance team and reviewed by the Function Manager and the GVP Quality Lead. An example is the sending of periodic reports to the Authority or reports with license partners.
    The OPI must be updated frequently, at least once a year.
  • Monitoring of KPIs by the parent company: set at the beginning of the year by the parent company, they are subject to monthly review by all quality leads, who may eventually define some corrective/preventive measures. The control takes place annually through a checklist.
  • Upper management monitoring: quarterly meetings in which the Quality System and KPIs are analyzed. In particular, the status of risks and improvements in the quality system, the status of deviations, internal and external audits, complaints, adverse events and AOB (Any Other Business) are monitored, such as the continuity of the company business during the pandemic.
    On the other hand, the General Manager, the Quality Leads and the Senior Management Team meet annually for the analysis of progress and trends and for the drafting of the formal plan for the annual improvement of the quality system which contains the achievement of the clear objectives of GxP main problems and challenges, improvements and projects for the following year, related summary and conclusions.

In conclusion – continues the doctor – the measurement of processes is the beating heart of the Quality System; the use of KPIs allows the realization of the quality cycle and therefore the continuous updating of the system itself.
The constancy of the monitoring and analysis of processes must be a Must Have for an affiliate to ensure compliance with the requirements of a System.