Some of the most common findings:
- Lack of proper systems and processes in place for detecting, reporting, and assessing adverse events related to their products.
- Failure to comply with regulatory requirements for reporting adverse events.
- Inadequate training of staff on pharmacovigilance procedures.
- Insufficient monitoring of post-marketing safety data.
- Issues with data integrity and accuracy in safety reports.
- Inadequate risk management plans for products.
- Failure to properly investigate and follow-up on reported adverse events.
- Failure to properly communicate safety information to regulatory authorities and healthcare professionals.
- It's important to note that these findings can vary depending on the specific company and products being audited, and that the purpose of such audits is to identify potential issues and improve the overall safety and efficacy of pharmaceutical products.
Regulatory Agency Inspections
Regulatory agencies during pharmacovigilance inspections can find a variety of issues, but some common key findings include:
- Lack of proper documentation and record-keeping: Agencies may find that companies are not properly documenting and maintaining records of adverse drug reactions (ADRs) and other pharmacovigilance-related data.
- Insufficient reporting of ADRs: Agencies may find that companies are not reporting ADRs to the appropriate authorities in a timely and complete manner.
- Lack of proper risk management plans: Agencies may find that companies do not have adequate risk management plans in place to identify, assess, and mitigate potential safety risks associated with their products.
- Insufficient training of personnel: Agencies may find that companies are not providing adequate training to their personnel on pharmacovigilance and ADR reporting requirements.
- Inadequate quality control processes: Agencies may find that companies do not have adequate quality control processes in place to ensure the accuracy and completeness of pharmacovigilance-related data.
- Lack of robust pharmacovigilance systems: Agencies may find that companies do not have robust and effective pharmacovigilance systems in place to effectively identify, assess, and manage safety risks associated with their products.
- Lack of compliance with regulations: Agencies may find that companies are not fully complying with pharmacovigilance regulations and guidelines.
Example from MHRA, U.K.
The MHRA (Medicines and Healthcare products Regulatory Agency) in the UK uses a pharmacovigilance inspection matrix to assess the compliance of pharmaceutical companies with pharmacovigilance regulations. The matrix is used to evaluate the systems and processes in place for monitoring the safety of medicinal products, including the reporting of adverse drug reactions and the management of risk. The inspection matrix covers a range of areas, including organization and management, pharmacovigilance systems, signal detection and assessment, and post-authorization safety studies. The inspection findings are used to identify any deficiencies and to develop a plan for corrective action.
Appended below is the Pharmacovigilance Inspection Metrics Report as an exhibit to support the above mentioned findings.
Pharmacovigilance Inspection Metrics Report (MHRA)
This write up has been authored by Kamal Shahani , Founder and Managing Director, Cliniminds. Cliniminds is the leading life sciences sector skilling organization. Cliniminds offers wide range of job oriented programs, up-skilling program and corporate training solutions in the field of clinical research, clinical data management, pharmacovigilance, QA Audits & Inspections, SAS, business analytics, biostatistics, medical writing, medical devices and regulatory affairs.