Regulated products like cosmetics, foods, supplements, medical devices, and drugs must be handled strategically from manufacture to end-use, and Health Canada and other regulatory bodies require the use of refined processes (“a quality system”) in all aspects of the supply chain.
The quality system specifies exactly how the product will be handled during manufacture, transport, storage, testing, and sale. A failure in the system can lead to costly product destruction or recalls, so careful design and execution of the system is critical. For products themselves, a main quality need is the (finished) product specification, which outlines exactly how the finished product will be tested prior to release for sale.
Depending on the activities performed (e.g. manufacturing, importing, distributing, testing, warehousing etc.) different procedures need to be applied, and many facilities will need to demonstrate compliance to the applicable standard by undergoing an on-site or paper-based audit by Health Canada prior to receiving a license to operate. Health Canada also has the right to inspect Canadian facilities at any time. Our consulting team is ready to work with you to create or customize standard operating procedures (SOPs) for your facility or finished product specifications (FPSs) for your products.
Your regulatory obligation doesn’t end when you receive your product or facility license, and our full-service support extends after you have come to market. Recalls and complaints are inevitable in any industry, and these must be handled expertly to minimize the impact on your business. Our consultants can determine if a complaint is reportable, assist with the report, and recommend customized corrective/preventative actions to circumvent future concerns. We can manage complaint reporting and complete recalls on your behalf.
Finally, depending on your business plan, volume, personnel capabilities, and possible recall action, your on-site quality assurance person may not be able to fulfill all requirements throughout the life-cycle of your operations. NHP Consulting is able to fill in this gap on a permanent or short-term basis. We can provide both on-site and remote quality support, ensuring that you are able to initiate or continue with your business when an on-site quality assurance person isn’t available or needs additional support.