Does a QA system always necessarily culminate in quality deliverables, is a million dollar question? And the answer to this question would vary from situation to situation based on the background & context. All said and done QA system in healthcare industry in India varies from almost non-existent to a standard at par with global requirements.

Quality Assurance, (which needs to be differentiated from ‘Quality Control’) is a very broad field, encompassing all GXP (GMP, GLP, GCP, GVP, GDP etc.) domains and beyond. India being the manufacturing hub of quality medicines, and one of the major exporter of API to US & EU, it is easier to understand that QA system including Good Manufacturing Practices are fairly prevalent and India boasts of many FDA approved manufacturing facilities. India’s participation in global clinical trials through Indian Affiliates of all major pharma companies & CROs ushered in and strengthened GLP and GCP disciplines in India. However same cannot be said about QA in Pharmacovigilance arena.

And in this area, the global players like US & EU have made rapid and far reaching progress, Indian pharma industry is lagging behind, being a late starter. The pharma companies in general and the Indian mid segment/ generic pharma companies started pretty late with their PV set ups, and few are still just contemplating. With the newly drafted GPVP guidelines for Indian pharma industry by CDSCO, its expected that PVQA in India would be more heard of and/or practised, in India in near future.

The Indian generic pharma companies always (erroneously) considered PV obligations to be responsibility of MNCs (Innovative companies). In addition, the PV set up has been always perceived as ‘Cost Centre’ without ‘Return On Investment (ROI) by the senior management and never got the type of support, it required.

However, with advent of the Pharmacovigilance Program of India (PvPI) version 2.0, and the various initiatives taken, the PV is reaching to people/places which was earlier not thought of. The implementation of GPVP guidelines would not only strengthen the PVQA but would also add to the understanding & realization of MAHs about their ultimate responsibility towards patients’ safety & well-being which of course can only be achieved through overall robust QA system including the Quality Assurance in PV domain.

The ‘EMA Module I -Pharmacovigilance Systems and their Quality Systems’ Effective 02 July 2012 discusses in detail about the essentials of PVQA and nuances thereof. It includes but not limited to topics such as;
n    Quality, quality objectives, quality requirements and quality system (section- I.B.2.)
n    Quality cycle (section- I.B.3.)
n    Overall quality objectives for pharmacovigilance (section- I.B.4.)
n    Responsibilities for the quality system within an organization (section- I.B.6.)
n    Training of personnel for pharmacovigilance (section- I.B.7.)
n    Facilities and equipment for pharmacovigilance (section- I.B.8.)
n    Compliance management by marketing authorization holders (section- I.B.9.1.)
n    Record management (section- I.B.10.)
n    Documentation of the quality system (section I.B.11.)
n    Critical pharmacovigilance processes and business continuity (section- I.B.11.3.)
n    Monitoring of the performance and effectiveness of the pharmacovigilance system and its quality system (section- I.B.12.)

Under section I.B.12, “Monitoring of the performance and effectiveness of the pharmacovigilance system and its quality system” the module extensively discusses topics such as, internal periodic reviews of the systems by those responsible for management; audits; compliance monitoring; evaluating the effectiveness of actions taken with medicinal products for the purpose of minimizing risks and supporting their safe and effective use in patients.

Through the Module I, EMA’s mandate on ‘Internal PV Audits’ is pretty clear & loud. Without any ambiguity the module stipulates the following;

“Risk-based audits of the quality system shall be performed at regular intervals to ensure that it complies with the requirements for the quality system, the human resource management, the compliance management, the record management and the data retention and to ensure its effectiveness. Audits of the quality system should include audit of the pharmacovigilance system which is the subject of the quality system. In relation to the pharmacovigilance system of a marketing authorization holder, a report shall be drawn up on the results for each quality audit and any follow-up audits be sent to the management responsible for the matters audited The report should include the results of audits of organisations or persons the marketing authorization holder has delegated tasks to, as these are part of the marketing authorization holder‘s pharmacovigilance system. As a consequence of the monitoring of the performance and effectiveness of a pharmacovigilance system and its quality system (including the use of audits), corrective and preventive measures should be implemented when deemed necessary. In particular as a consequence of audits, corrective action(s), including a follow-up audit of deficiencies, shall be taken where necessary. Additionally, the competent authorities should have in place arrangements for monitoring the compliance of marketing authorizations holders with legally required pharmacovigilance tasks and responsibilities. They shall further ensure compliance with the legal requirements by means of conducting inspections of marketing authorization holders”.

The above mandate does not leave any other option for the MAHs (specially operating in EU) but to fall in line and conduct risk- based audits of PV Systems, including affiliate offices, marketing partners, vendors (particularly conducting market research programs /patients support programs) and to include all ‘Critical’ & ‘Major’ findings in the PV System Master File (PSMF) till CAPAs are in place and these observations are closed. Hence by virtue of including the critical & major findings from internal audits, the PSMF becomes an extremely important & effective tool in the hands of competent authorities/health authorities to evaluate the health of the PV system of all the MAHs operating in their territories.

And this is clearly a big challenge for the pharmaceutical companies as most of them do not either have a PVQA team in place or sufficiently large /competent QA team to conduct PV audits of all the stakeholders as required by the EU Regulations. Looking at the current trends in the industry, more and more pharmaceutical companies are forced to either set up/strengthen their own PVQA function and/or outsource PV audits to competent service providers. Its only matter of time, that other health authorities take a cue from EMA and expect all MAHs to comply with audit requirements, and hence any complacency and/or procrastination by pharma companies in this regards, can only be a potential business risk not worth taking.                                          

(The author is CEO & Founder of PVCON Consulting Services)