Site Audit

A site inspection is periodically conducted to ascertain that your manufacturing, packaging, labeling, importing, or distribution center complies with Health Canada regulations.

What is a Site Audit?

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. 

Why is a Site Audit Important?

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.

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Standard Operating Procedures

A thorough site inspection lets you operate with Standard Operating Procedures in place.

Good Manufacturing Practices (GMP)

With site audit, you will be able to follow current Good Manufacturing Practices (GMPs).

Suggestions for Improvement

A written audit report is provided detailing observations, deficiencies and where improvements are required.

Improved Operations

Site audit leads to improving your operations and preparing you for a government audit on-site.

Health Canada Audit Solutions

Ensure you are prepared and protected to meet Canadian regulatory standards

Food Facility Audit

Following the Safe Foods For Canadians Regulations (SFCR) and FSEP to ensure your PCP or HACCP is in good standing.

NHP Site Audit

Reviewing your documentation and processes as per NHP GMP requirements either before or during a Health Canada inspection.

Drug Establishment Audit

Conduct a pre or post-inspection of your activities, operations and documentation aligning with drug GMPs.

Cosmetic Facility Audit

Review operations and documentation with Health Canada's cosmetic manufacturing GMPs.

FDA Audit Solutions

Ensure you are prepared and protected to meet Canadian regulatory standards

Food Facility Audit

Following the Food Modernization Act (FSMA) to ensure a robust and compliant food safety plan is in place

Dietary Supplement Facility Audit

Reviewing your documentation and processes as per 21CFR part 210 and Part 211 GMP for dietary supplements.

Drug Facility Audit

Review all processes, operations and documations as per 21 CFR Part 210 and 21 CFR Part 211.

Cosmetic Facility Audit

Reviewing cosmetic Good Manufacturing Practices (GMP) as per the Modernization of Cosmetic Regulatory Act (MoCRA).

Hear from Some of Our Amazing Clients

Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with Health Canada

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NHP
health canada natural health products database
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NHP Database
nhpd ingredient database
Shams W.Pawel Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael MT Consulting

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.

Donal Gauvreau Sapro

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!

Frequently Asked Questions

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.

  1. Standard Operating Procedures (SOPs)
  2. Good Manufacturing Practices (GMP) Records
  3. Data logs
  4. Certificates of Analysis and Batch Production Records

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