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Audits and Regulatory Inspections

PharSafer® has conducted audits globally, both for Pharmacovigilance (PV) and Good Clinical Practice (GCP), covering the European Union, USA, Canada, Eastern Europe and South East Asia (Japan, India, Taiwan, South Korea) for many Pharmaceutical Companies.

Our auditors are rigorous in terms of identifying weaknesses in systems and procedures. We are employed by you to determine any non-compliance, whether these are at a company process level, training, or legislative non-compliance.

There would be little point in PharSafer® performing an audit and ‘holding back’ on any findings or gradings. The regulators would certainly not hold back and, therefore, it is important for our auditors to be honest and objective.

However, the key element of our audits is objectivity. We aim to ensure that any findings are aimed at the specific country legislation, processes and training provided.  Our approach towards to Root Cause Analysis (RCA) and Corrective Action Plan Activities (CAPA) is very much one with a human face looking for practical solutions which can be implemented and followed.

The audits we have performed have been on behalf of those various companies as a part of their own internal Quality Management assessment and compliance with their company own standards, as well as their marketing partners/distributors in line with their safety agreements. Additionally, the audits have been performed by PharSafer® as part of due diligence exercises for the purchase of entire companies or individual products.

All audits are conducted by experienced safety/clinical auditors from PharSafer®. All audit schedules and content are agreed with the client before being conducted.  All audit reports are presented as draft and finalised documents with categorised findings according to the seriousness of the finding. All audits are certificated, signed and dated. PharSafer® also participates in approval of any Corrective Action Plans, including identifying Root Cause Analyses, resulting from an audit to ensure that the findings will be adequately addressed and resolved.

Why Audit?

  • To understand where the Company/Affiliate/Marketing partner is at in terms of compliance to legislation, performance to targets and identify possible business process inefficiencies
  • To provide a measure of progress from the last audit as part of Quality Management
  • To identify areas of business/company risk, and the extent of that risk
  • To identify gaps in processes and training
  • Because it is a requirement of the Regulatory Agencies
  • To ensure the Company is prepared for a Regulatory Inspection
  • Most importantly, to ensure that the Company is providing the best approach to enable accurate assessment of the safety profile of its products in order to protect patients and advise prescribers.

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The purpose of a Pharmacovigilance Audit

  • Conduct a diagnostic overview of all pharmacovigilance and Medical Service activities to gain an understanding of the current position, best practices and the adherence to current regulations
  • To ensure company compliance and brand protection is observed, gaps and risks are identified and priorities can be established to achieve maximum compliance as rapidly as possible.

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The Audit Process

  • Company / Client Pharmacovigilance strategy
  • Regulatory compliance of third party assessments
  • Company structure / PV organisation for responsibilities and links
  • Assess skill and resource competency
  • Review interfaces and communications between strategic partners, affiliates, marketing partners and other outsource vendors
  • Review tools used in reporting in analysing safety data to determine improvements and possible enhancements
  • Review of signalling and surveillance activities including any activities resulting from such activities
  • Performance monitoring against Company and Regulatory standards
  • Quality assurance and control processes as part of the overall Quality Management Strategy.

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Types of Audit

  • Global Pharmacovigilance
  • Company Affiliates
  • Marketing Licensing Partners
  • Due Diligence Audits for newly acquired or proposed purchases of products and Companies (mergers and takeovers).

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Risk Management

  • Identify involved parties: Pharmacovigilance Systems / Affiliates / Marketing Partners
  • Communicate in a timely manner
  • Identify Risk Factors:
  • Volume of adverse events
  • Clinical Trial Activity
  • Number of external contracts
  • Label updates
  • Safety Reviews/Signal detection
  • Previous audit history
  • Compliance data
  • Training of staff and resource capabilities.

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PharSafer® have attended over 100 Inspections with Pharma clients around the world (up to date as of Dec 2014) and so have a lot of first-hand knowledge of what to expect from a Regulatory Inspection. Additionally having been inspected ourselves by various Regulatory Agencies 24 times over the last seven years on behalf of clients, we understand what the Regulators want to see also.

As part of getting Companies prepared for Inspections from the Regulatory Authorities, PharSafer® also help Companies by performing mock Inspection exercises, interviews and help with how to answer questions openly and honestly, how and what documents may be required, and an overall Company assessment.

We can also help through an Inspection as well by helping in the documents being retrieved and document checking as well as noting the questions asked, helping clarify questions and providing Company advice while being unobtrusive and staying in the background.

Following an Inspection we can also help in any RCA determinations and CAPAs and help fix the problems following an Inspection.

Additionally, PharSafer® has worked with many Companies in the preparation, conduct, and corrective actions following Regulatory Inspections for Pharmacovigilance and for GCP from the MHRA; IMB, FDA, ASNM; DKMA; MPA; BfArM; FDA; HPB; MEB; AGES; FAMHP; and EMA directed Inspections.

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Gap-fills versus Audits

Separate from a formal audit which needs to be documented with Root Cause Analyses (RCAs) and Corrective Action Plan Activities (CAPAs); PharSafer® also perform gap-fill analyses for clients.

These are designed with the knowledge that the system is not working properly and there are gaps in process; training etc… and rather than go through a formal audit (which can be conducted later); a gap fill analysis is what the Company really needs to explain what needs to be fixed, how to do it, what gaps there are in processes; whether the existing processes can be improved; so that the Company can go away with the knowledge of what to do, how to prioritise and once they have implemented everything, then conduct the audit to determine if what you think is a fully compliant and functioning system, is actually capable of withstanding a Regulatory audit.

The approach here is analogous to accepting that you have a house half-built; asking for help to complete it and then once complete calling in the building Inspectors to approve the completed house (audit).

Such gap-fill approaches do not get included into the PSMF because they are not formal audits and it does allow people performing the gap-fill to explain, discuss, offer advice and help wheras in audits this cannot happen.

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