Everyone likes numerical rankings and Health Canada believes it is time to assign them to drug manufacturing plant inspections.
New guidance just published by the regulator shows it will institute a three-level ranking system for plants divided by high-risk and low-risk products, rather than issue a simple "compliant" or "non-compliant" designation.
The new rules are to make sure companies know what will create a non-compliance ruling and so set them up for some kind of intervention from the government. It should give plant operators some idea of what their worst offenses are and what needs to be addressed first. It also helps to ensure that all inspectors are treating violations the same way, the announcement says.
So how do they divide out?
- Risk 1: This is considered critical and likely to mean a plant is non-compliant, with all of the possible consequences of that. Those kinds of observations are for problems "that may result in an immediate or latent health risk and any observation that involves fraud, misrepresentation or falsification of products or data.
- Risk 2: These are issues that may result in the production of a drug not consistently meeting its marketing authorization.
- Risk 3: This is when a plant is not practicing good manufacturing practices.
High-risk products include anything where there may be a health risk from cross contamination, such as penicillin, and certain cytotoxic and biological products. Low-risk products are pretty much anything that are not sterile meds, like veterinary drugs.
The document says the overall inspection rating is based on the risk involved and will take into account the nature and extent of the deviations, whether they involve high-risk or low-risk products. It warns, however, that a plant could be considered out of compliance, and ordered to make changes or even to halt production, if it has a lot of Risk 2 violations or has failed to address Risk 2 and Risk 3 problems from earlier inspections.
The publication of the new rules came at about the same time the FDA's Janet Woodcock said some changes may be in order in how the U.S. agency tracks quality and handles inspections. In a recent letter to her underlings, Woodcock emphasized the need for a "robust" drug quality program. She also said she may create an "Office of Pharmaceutical Quality (OPQ)," to oversee quality throughout the lifecycle of a drug.
The agency has gotten more regulatory authority and responsibilities to oversee drug manufacturing throughout the world, and has been under public and political pressure to ensure drug are safe and effective.
- here are the guidelines (PDF)
- more from in-Pharma Technologist