Pharmacovigilance Inspections in the EAEU: Key Changes and Preparation  January 25, 2024

Pharmacovigilance Inspections in the EAEU: Key Changes and Preparation 

The additions to the pharmacovigilance system inspection rules emphasize the possibility of inspecting Marketing Authorisation Holders (MAHs) at any time. Important to know: 

  • Inspections can be conducted without prior notice in exceptional cases, for example, when significant risks to public health are identified 
  • Routine practice includes prior notification, usually 45 days before the planned inspection 
  • The notification period may vary depending on the situation and the need for an urgent assessment.  

Preparing for a pharmacovigilance system audit is a key step to ensure compliance with applicable regulations and a high level of pharmaceutical standards. This process requires careful preparation and attention to detail to ensure the effectiveness and completeness of the inspection.

Preparation for a pharmacovigilance system inspection includes the following steps:

1. Review of Documents
Inspectors examine the provided documents from the inspected organization, describing the pharmacovigilance system, including data on previous inspections and their results.

2. Scope Determination of the Inspection
Based on the type and objectives of the inspection and the reviewed documents, inspectors determine which components of the pharmacovigilance system will be inspected.

3. Development of the Inspection Program
Inspectors approve a program that includes the objectives and scope of the inspection, the division of responsibilities among inspectors, the date and location of the inspection, and a list of documents and resources for the assessment.

4. Logistical and Organizational Preparations
The format of the inspection (online or offline) is approved, and the inspected organization shall be notified of all upcoming activities and requirements, including the possible use of remote communication tools.

During the pharmacovigilance system inspection, various aspects are assessed, including compliance with documentation, operation of computerized systems, interviews with staff, and analysis of internal and external correspondence. The inspection may be adapted according to factors discovered or specific circumstances, including changes in the scope or focus of the inspection.

All observations and results of the inspection are carefully documented and identified non-compliances are categorized and discussed at the final meeting between inspectors and representatives of the inspected organization. Following the inspection, a corrective and preventive actions plan (CAPA) must be compiled within 30 working days of receiving the report. 

Inpharmatis offers comprehensive support in preparing for a pharmacovigilance inspection, including: 

1. Preliminary Audit of the Pharmacovigilance System
Inpharmatis experts will conduct a detailed pre-audit of your pharmacovigilance system to identify potential vulnerabilities and areas for improvement.

2. Training Interviews with Staff
Conducting interviews with your employees to enhance their readiness for real inspectors' questions.

3. Preparation for Logistical and Organisational Aspects
Provide consultations on all logistics and organizational aspects to ensure the successful result of the inspection.

4. Preparation of Recommendations Based on the Audit Results
Organisation and optimisation of pharmacovigilance documentation and processes, ensuring their compliance with current regulatory requirements.

* Also, Inpharmatis specialists propose expert support of CAPA plan preparation

Request a consultation now at info@inpharmatis.com.

Article author
Hanna Balyka,
Pharmacovigilance Manager
Inpharmatis