MoCRA GMP Delayed Until October 2025: What You Need to Know
Learn about the FDA’s delay of MoCRA GMP to October 2025 and discover how cosmetic companies can prepare for compliance with MoCRA regulations.
... Read moreA site inspection is periodically conducted to ascertain that your manufacturing, packaging, labeling, importing, or distribution center complies with Health Canada regulations.
A Site Audit is a standardized process utilized by experts to determine whether you are complying with Health Canada and FDA standards in manufacturing, packaging, labeling, and distributing products. A site Audit or site inspection checklist brings a pristine faction of eyes to assess your logs and procedures and discover where there are deficiencies. With a site inspection checklist, our site audit specialists will check your site and compile a report, including recommendations, and analysis.
A site inspection makes sure that your manufacturing, packaging, labeling, importing, or distribution of facility properly document all activities consistently, practices due diligence in all areas, and meets the regulations set by Health Canada. We will work as your site audit specialist with expertise in providing a personalized, walk-through inspection of your facility. The site audit is essential and should be conducted periodically for the following reasons.
A thorough site inspection lets you operate with Standard Operating Procedures in place.
With site audit, you will be able to follow current Good Manufacturing Practices (GMPs).
A written audit report is provided detailing observations, deficiencies and where improvements are required.
Site audit leads to improving your operations and preparing you for a government audit on-site.
Ensure you are prepared and protected to meet Canadian regulatory standards
Following the Safe Foods For Canadians Regulations (SFCR) and FSEP to ensure your PCP or HACCP is in good standing.
Reviewing your documentation and processes as per NHP GMP requirements either before or during a Health Canada inspection.
Conduct a pre or post-inspection of your activities, operations and documentation aligning with drug GMPs.
Review operations and documentation with Health Canada's cosmetic manufacturing GMPs.
Ensure you are prepared and protected to meet Canadian regulatory standards
Following the Food Modernization Act (FSMA) to ensure a robust and compliant food safety plan is in place
Reviewing your documentation and processes as per 21CFR part 210 and Part 211 GMP for dietary supplements.
Review all processes, operations and documations as per 21 CFR Part 210 and 21 CFR Part 211.
Reviewing cosmetic Good Manufacturing Practices (GMP) as per the Modernization of Cosmetic Regulatory Act (MoCRA).
Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with Health Canada
I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.
A site inspection should be conducted periodically to ensure that your manufacturing, packaging, labeling, importing, or distribution center complies with Health Canada regulations.
A site audit is a standardized process utilized by experts to determine whether you are complying with Health Canada and FDA standards in manufacturing, packaging, labeling, and distributing products. A site audit or site inspection brings a pristine faction of eyes to assess your logs and procedures and discover where there are deficiencies. With a site inspection checklist, our site audit specialists will have a look at your site and compile a site audit report to outline deficiencies, areas of improvement and recommendations.
A site audit helps to ensure that your manufacturing, packaging, labeling, importing, or distribution facility properly documents all activities consistently, practices due diligence in all areas, and meets the regulations set by the regulatory body. We will work as your site audit specialist to provide a personalized, walk-through inspection of your facility.
Follow Latest News, Blogs & Industry Updates
Learn about the FDA’s delay of MoCRA GMP to October 2025 and discover how cosmetic companies can prepare for compliance with MoCRA regulations.
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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.