2025-07-11

Understanding USP <61>, <62>, <2021>, and <2022>: Microbiological Testing for Dietary Supplements in Western Canada

Introduction

As the popularity of dietary supplements continues to rise across Western Canada, ensuring product safety has never been more crucial. One of the most important aspects of supplement quality control is microbiological testing—specifically in alignment with USP <61>, <62>, <2021>, and <2022> standards.

For manufacturers and quality teams in Alberta, British Columbia, Saskatchewan, and Manitoba, understanding these guidelines is a key step toward regulatory compliance and consumer safety.

What Are USP <61>, <62>, <2021>, and <2022>?

USP <61> — Microbial Enumeration Tests

This standard outlines how to measure total aerobic microbial counts (TAMC) and total combined yeast and mold counts (TYMC) in non-sterile products.

USP <62> — Tests for Specified Microorganisms

Designed to detect pathogens such as:

E. coli
Salmonella spp.
Staphylococcus aureus
Pseudomonas aeruginosa
Candida albicans

These organisms are objectionable and must be absent from dietary supplements.

USP <2021> and <2022>

These chapters adapt <61> and <62> for dietary supplements, which often contain complex natural ingredients that can influence microbial content and testing conditions.

Why These Standards Matter in Supplement Testing

Adhering to these USP guidelines ensures that your products:

Are free of harmful microorganisms
Meet Health Canada and FDA safety benchmarks
Maintain batch consistency
Support safe shelf life and consumer use

For companies exporting supplements or marketing across Canada, testing based on these USP standards is often mandatory.

Considerations for Western Canadian Producers

Operating in Western Canada brings regional challenges such as:

Seasonal ingredient variability
Diverse manufacturing conditions
Increased demand for traceability and transparency

Integrating microbiological testing early in your production process reduces the risk of product recalls and protects your brand reputation.

How to Implement USP-Compliant Testing

To get started:

Know your product — its ingredients, format, and intended use
Determine applicable USP chapters based on formulation and distribution plans
Choose an ISO-accredited lab familiar with dietary supplements and USP standards

Need Support?

At PBR Laboratories Inc., we specialize in microbiological testing for dietary supplements using USP <61>, <62>, <2021>, and <2022> protocols. Based in Edmonton, Alberta, we support manufacturers across Western Canada with reliable, ISO-accredited testing solutions.

Whether you're launching a new product or validating your process, we're here to help.