Overview - Pharmacovigilance Audits and Inspection

The reason regulations are stringent is to ensure maximum patient safety along the entire drug development pipeline- from research to post-marketing activities. Maintaining compliance with regulatory requirements is crucial as it ensures patient safety. For this reason, as pharmaceutical products progress through their life cycle, they must be compliant to laws, procedures, and regulations set by authorities.Similarly, pharmacovigilance Services and quality systems that are put in place must consistently be reviewed and verified by conducting regular audits.

DDReg’s Audit personnel review all pharmacovigilance systems and their implementation and operation. Our team is committed to ensuring that all pharmacovigilance processes are in adherence to regulatory requirements such as ICH guidelines, E2B(R3), E2C(R2), GVP modules, FDA, E2E etc. Additionally, DDReg provides training in PV Audit to ensure that the organization’s staff are aware of maintaining compliance to such regulatory services requirements.

DDReg Pharmacovigilance Compliance Audits Expertise:

  • Experienced and highly educated and trained on subjects related to PV audits
  • Review compliance audit to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Conducts regular gap assessments of PV staff at site location
  • Provides organizational training on safety audits and inspections

Basics of Audit and Compliance services in pharmacovigilance

Pharmacovigilance activities are pivotal in ensuring patient safety and safeguarding public health. As the Pharmaceutical industry evolves, it affects pharmacovigilance and drug safety surveillance. Hence, the need for robust audit and compliance services in pharmacovigilance is highlighted, especially with respect to safety data exchange agreements (SDEA).

The SDEA serves as a critical framework for sharing safety information among key pharmacovigilance stakeholders that are involved in drug development and post-market safety surveillance. It outlines the terms and conditions for the exchange of safety information, fostering transparency and collaboration. Given the intricate nature of pharmacovigilance, audit and compliance services act as a safeguard to ensure that the SDEAs are not only established but also diligently adhered to.

Audits are integral in evaluating how effective a pharmacovigilance system and/or process is to ensure that adverse events are promptly reported so that effective and appropriate pharmacovigilance risk management strategies are in place. Compliance services help to align pharmacovigilance practices with regulatory requirements and industry standards. Indeed, these services offered by DDReg help pharmaceutical organizations navigate the complex web of regulations and guidelines, mitigating the risk of non-compliance which could lead to severe consequences.

In a era where the globalization of clinical trials and drug development is the norm, the SDEA becomes a linchpin in fostering international safety collaboration. Audits and compliance services at DDReg ensure the SDEA is not just a formality but a living document that reflects the commitment of all parties to prioritize patient safety. By emphasizing the importance of these services, the pharmaceutical industry can elevate pharmacovigilance practices, ultimately enhancing the overall safety profile of drugs.

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