Health Canada, the national regulatory authority of Canada, has advised drug establishment license holders that it will increase the frequency of planned and unplanned inspections as well as unplanned onsite visits as part of its compliance and enforcement activities relating to good manufacturing practices (GMPs). The department said that it is increasing inspections in the wake of problems arising in several areas, including supply-chain integrity for active pharmaceutical ingredients (APIs) and data integrity.
Specifically, the department said during recent inspections focused on APIs, it has noted a number of issues in traceability (supply-chain integrity), vendor qualification, cleaning validation, data integrity, and packaging conditions. The department said it has taken compliance and enforcement actions, where appropriate.The data-integrity issues were noted in several facilities domestically in Canada and globally.
"Health Canada continues to monitor these issues and expects regulated parties to provide information as requested while also demonstrating how the integrity of data is ensured in their facilities as well as any facilities with which they are linked through contractual agreements.," said the department in a statement.
The department said that it also plans to increase transparency as it relates to the inspection process. Initial transparency initiatives have involved posting lists of inspections and ratings as well as summary report of inspections resulting in a non-compliant rating. Beginning April 1, 2015, GMP inspections will be summarized and posted as part of Health Canada's Openness and Transparency Framework. These summaries will be posted as soon as possible following the onsite inspection or review of GMP evidence, prior to the rating being finalized. If changes occur following the initial posting of observations, the posted version would also be updated. Health Canada is also planning increased transparency regarding on-going issues related to health products and establishments, building on the transparency initiatives that were launched in late 2014. To that end, the Department has posted an Inspection Tracker: Drug Manufacturing Establishments. This tracker provides a regular snapshot of the potential health and safety issues Health Canada is tracking with companies that make, package, test, wholesale, distribute, or import drugs for sale in Canada.
Source: Health Canada