Any drugs distributed on the Canadian market must remain safe and effective for public use. Pharmacovigilance inspections ensure that the establishments producing those drugs are following the correct regulatory requirements. This involves performing GCP and GVP inspections.
GCP inspections happen during the clinical trial stage to ensure compliance, while GVP inspections happen in the post-approval stage to verify that establishments continue to evaluate the safety and effectiveness of their drugs.
As a professional working in clinical research, you should have a clear understanding of the goals, process and impact of these inspections. With this knowledge, you’ll be ready to handle inspections as either a clinical research coordinator or a pharmacovigilance officer. Here are some tips to get started.
Understand What Inspectors Look for
After completing your clinical research training, you might be looking to play a crucial role in conducting and managing clinical trials for new drugs. Or you might be looking to work as an inspector or auditor who monitors pharmacovigilance in trials. In each case, you’ll need to understand the purpose of GCP and GVP inspections in order to act or prepare for them accordingly.
A GVP inspection is designed to determine whether a drug establishment is following post-approval regulations. Inspectors will be looking to verify that establishments are:
- Monitoring the ongoing safety of drugs
- Reporting any adverse drug reactions (ADRs) to the federal government
- Preparing annual summary reports after a drug has been approved
A GCP inspection, on the other hand, aims to reduce the risk to subjects enrolled in clinical trials. Along with compliance, GCP inspections also verify the integrity of data and encourage sponsors to continue in their research activities.
Prepare Checklists After Clinical Research Training
Preparing for these inspections carefully is half the battle of passing them. At the same time, knowing what to look for will make your job as an inspector a whole lot easier. Professionals with a clinical research diploma know that there are many elements to monitor during the trial and approval stage of a new drug.
When it comes to GVP, inspectors will typically look for:
- Records of ADRs
- Reports on any failures in the effectiveness of new drugs
- Annual summary reports dating back 25 years
During the clinical stage, GCP inspectors will be examining clinical trials at the premises of pharmaceutical companies. In that case, inspectors will look for evidence of:
- Qualified personnel
- The proper handling, storage, and manufacturing of the drug
- Protection of the rights and safety of research subjects
Regulated organizations are expected to understand their obligations, ensure their products and processes are compliant with regulations and assist inspectors with the necessary documents. Preparing a checklist ahead of time is a good way to ensure that the inspection runs smoothly.
At AAPS, students gain the skills to prepare and host a regulatory inspection, and to facilitate the response to inspection findings. Students will learn about preparing inspection checklists that are required for conducting inspections and audits including examining products, processes or systems.
Take Corrective Actions
It’s important to know what to expect after an inspection and how to handle the results, particularly as a clinical research professional. Clinical research organizations will receive an overall rating of compliant or non-compliant. If a non-compliant rating is given, the inspector will likely request corrective actions to be done immediately. As a clinical research professional, you’ll need to develop a plan to implement corrective actions, including target deadlines. Likewise, as an inspector, you’ll need to schedule another inspection to evaluate those actions. If the risks of the drug to the public are too great, market approval should be reevaluated.
With a clear understanding of what to expect from GCP and GVP, you’ll be ready to manage these inspections as either an investigator or a clinical researcher.
Are you looking to get started with clinical research courses?
Contact AAPS to learn more about our program!