Health Canada looks to crack down further on noncompliant manufacturers
In a letter sent to manufacturers last month, the regulator noted that “in light of the some of the concerns” around GMP compliance, there may be an uptick in the frequency of planned and unplanned inspections as well as unplanned onsite visits for the purposes of compliance verification.
The regulator is working with the US FDA and other global counterparts on these inspections.
“By spring 2015, Health Canada plans to publish a list of foreign facilities including the rating provided,” spokesman Eric Morrissette told In-Pharmatechnologist.com. “Summaries of inspections for foreign facilities will be included in a future iteration of the inspection transparency plan.”
Transparency
Health Canada is also looking to ramp up its own transparency efforts related to its inspections and findings. The regulator recently posted all of its inspection results from 2012 through 2014. Six companies were declared noncompliant in 2014, which included importing issues related to SciCan, and quality control at Contract Pharmaceuticals.
And 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,” according to the letter.
Recent Findings
The crackdown comes as Health Canada has uncovered a number of deficiencies specifically around API manufacturers and data integrity issues.
“During recent inspections focused on activities related to API, Health Canada has noted a number of issues in the areas of traceability (supply chain integrity), vendor qualification, cleaning validation, data integrity and packaging conditions and has taken compliance and enforcement actions, where appropriate,” Health Canada says.
Data integrity issues have also recently been noted in several facilities domestically and globally, including for India’s Ipca Laboratories, Sri Krishna Pharmaceuticals and Dr Reddy’s. 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.”
The drug regulator adds that it expects that all regulated companies adhere to Good Manufacturing Practices (GMP) by ensuring processes, systems, training and expertise of employees are meeting the regulatory requirements.
