GVP and GCP Inspections: How They Affect Clinical Research

When a drug is ready to be widely distributed, GVP and GCP inspections are necessary steps to take beforehand. GVP inspections are done for any establishment selling or importing a drug after its approval, while GCP inspections are undertaken during clinical trials. Such inspections are meant to ensure these trials are compliant with regulations, the establishments are reporting any adverse reactions to the drug(s), and that integrity and quality control standards are met. Short for Good Pharmacovigilance Practice and Good Clinical Practice respectively, these inspections are also completed to make sure all participants will be safe during the trials.

Here’s what you should know about GVP and GCP inspections, and the role they play in clinical research.

GVP Inspections: How Drug Safety Can Be Maintained When It’s Time to Sell Them

Any GVP inspection should ensure that an establishment—known as a Market Authorization Holder (MAH)—selling drug products must have a robust management program in place when there is a risk of any adverse drug reactions. In Canada, these establishments also must adhere to regulations set out by the Food and Drug Act. 

The GVP inspection process aims to ensure the safety and efficacy of a drug once it has been approved and has hit the market, and that the establishment selling them is adhering to federal regulations. Once these inspections have taken place, the Canadian federal government stipulates that any establishment selling these products and undergoing GVP inspections will need to:

• Keep their records of adverse drug reactions (ADR) for the next 25 years
• Prepare ADR reports to Health Canada after collecting and evaluating data regarding adverse reactions
• Establish a system that ensures the highest possible quality for these reports and maintains high standards for managing ADRs
• Prepare post-approval annual summary reports

Glad adult man pharmacist writing down assortment of drugs in pharmacy

All of this is important if you are considering a clinical research program, since you will learn about pharmacovigilance activities and Good Pharmacovigilance Practices (GVP) during your studies. Any Market Authorization Holder must first undergo a GVP inspection before they are permitted to sell the drug. 

As mentioned earlier, records of ADRs must be kept for 25 years, so that the federal government can continue overseeing the drug’s safety and track the reactions of those taking it. The government may also request changes to labelling during this timeframe.

GCP Inspections: Ensuring Drugs Are Safe During Clinical Research Trials

Before a GVP inspection can be conducted, the drug product must also be inspected during the clinical trial stage. Any individual accountable for the clinical trials being carried out is known as a qualified investigator.

Qualified investigators must make sure participants are safe during clinical trials

Whenever drug products are being tested on human participants, an inspection must be undertaken to ensure the clinical trials adhere to the Drugs for Clinical Trials Involving Human Subjects section (Division 5) of Health Canada’s Food and Drug Regulations. During inspections, factors that are evaluated include:

• The training and experience of all personnel conducting the trial
• Compliance with Health Canada requirements about obtaining informed consent from volunteers before the trial
• The documentation and reporting of any adverse reactions and events
• The proper handling, storage, and manufacturing of the drug
• Confirmation of possible provisions for the maintaining of ADR records for the next 25 years
• The party conducting the trial is sufficiently supervising all medical care

Organizations conducting these clinical research trials (known as sponsors) must keep their human participants safe without unnecessary risk for their health, and ensure participants are informed in writing about the study and its potential risks. Once the inspection has been completed, a rating of either “compliant” or “non-compliant” will be given. Should the latter rating be issued, sponsors and qualified investigators must complete the following actions:

• Corrective action must be taken immediately for all instances of non-compliance
• A plan for these corrective actions must be developed, written by the sponsors, and submitted to Health Canada
• The plan must also list targeted deadlines for completing these actions
• Authorization for clinical trials may be suspended either at a specific location or entirely

If a GCP inspection finds instances of non-compliance, action must be taken to correct them

Even if a compliant rating is issued, corrective actions may need to be taken for certain aspects of the trial. A second inspection may also become necessary to ensure these actions are successfully completed. By conducting GCP inspections, participants in clinical trials can be assured that they are undergoing these trials with as little risk to their health and safety as possible.

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