In 2015, TGA initiated its pilot for the Pharmacovigilance Inspection Program (PVIP). Among the select few service providers, Commercial Eyes (A ProductLife Group Company) has contributed to the program’s inaugural success. Since then, our team has continuously enhanced its expertise, demonstrating proficiencies in TGA inspections over the years. We have also undergone numerous client-based audits, with business partners based locally and overseas. In the past 12 months alone, we have participated in at least 30 audits, whether initiated by a client’s business partner or the client themselves.
We are proud of our proven track record, having successfully navigated through the PVIP, undergoing 11 TGA inspections, without any critical findings. We have also undergone a rigorous US FDA Audit with no 483 findings.
Commitment to Excellence
Our track record highlights the dedication to uphold excellence on both regulatory compliance and client satisfaction. Key to this is our well-equipped Patient Safety Team, which comprises of science-background professionals with extensive experience and knowledge in pharmacovigilance.
Through active participation in inspections conducted by the TGA and audits by business partners, our team have acquired invaluable insights and expertise. As a result, we ensure that our clients are consistently prepared for audits and inspections. This, in turn, has enabled us to monitor our clients’ pharmacovigilance practices. We ensure they remain compliant with regulatory guidelines and are inspection-ready. And in response to the evolving regulatory landscape, we offer an expanded suite of services aimed at providing comprehensive guidance and assistance to both new and existing clients.
Inspection Readiness Support
With our extensive experience in successfully navigating regulatory inspections, We offer tailored consultation services to ensure that clients are fully prepared for inspections conducted by regulatory authorities. Our Patient Safety Team will work closely with your team to review your pharmacovigilance systems, procedures, and documentation, ensuring compliance with regulatory requirements and industry best practices. Our team will also provide coaching advice on how to respond properly to face-to-face interview questions.
Gap Analysis and PV System Review
Recognising the importance of maintaining robust pharmacovigilance systems, Our team provides comprehensive gap analysis services to assess the effectiveness and compliance of your existing pharmacovigilance systems. We will conduct a thorough review of your documents and processes, identify any gaps or areas for improvement, and provide actionable recommendations to strengthen your pharmacovigilance framework.
Business Partner Audits
In addition to regulatory inspections, we understand the significance of maintaining strong relationships with business partners in the pharmaceutical industry. To support this, our team can provide support on business partner audit services to evaluate the pharmacovigilance practices of your partners and vendors. We will conduct thorough audits, assess compliance with contractual obligations and regulatory requirements, and provide insights to help you mitigate risks and strengthen your partnerships.
Case Studies
Our team assisted a client in preparing for a TGA inspection through conducting a comprehensive PV system gap analysis. We simulated an inspection-like scenario by leveraging on previous inspection experiences which included reviewing the client’s processes through document requests and facilitating interview sessions. Subsequently. we provided an extensive inspection report and also offered guidance on addressing the identified deficiencies. The insights gained from this exercise proved instrumental for the client as they underwent an internal audit after the project’s completion.
Our team provided Inspection Readiness support by focusing on reviewing the client’s workstreams, including Regulatory Affairs, Medical Affairs, Commercial, Quality, and other relevant departments. We achieved this through the review of procedural documents, conducting stakeholder and key personnel meetings, and organising employee upskilling activities, such as mock inspection interview sessions. These efforts resulted in a tailored solution to ensure our client’s success.
Our team supported a global PV client in auditing their business partners. Collaborating closely with the client, we developed an extensive audit plan encompassing the client’s business partners and local affiliates. This comprehensive approach ensured that the client maintained a robust PV framework and remained compliant with regulatory bodies across various territories. Our knowledge and expertise beyond Australia and New Zealand were instrumental in this process, showcasing our ability to navigate international regulatory requirements.
To learn more about how Commercial Eyes can support and guide you through TGA Inspection preparation, internal gap analysis and PV system review or conducting business partner and vendor audits, please contact Lorenza Ricacho, Regional Head of Patient Safety at [email protected].
Lorenza Ricacho
Regional Head of Patient Safety
Lorenza has been with Commercial Eyes since 2011 and leads our Patient Safety and Risk Management team supporting our clients from the pharmaceutical, medical devices, generics & OTC, cosmetics sectors...
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