Certifications go far beyond logos on a label; they reflect a manufacturer’s commitment to safety, quality, traceability, and global compliance. Each standard, from cGMP to Fair Trade, addresses a specific part of the capsule manufacturing process, ensuring consistent practices and verified quality.
Together, these certifications form the foundation of integrity in pharmaceutical and nutraceutical production. Below is an overview of the key ones and their relevance to compliance and market access.
1. cGMP Certification
Current Good Manufacturing Practice (cGMP) certification, regulated by the U.S. FDA (21 CFR Parts 210 & 211), ensures that every stage of capsule production; environment, equipment, personnel, and documentation, follows strict, repeatable protocols.
A cGMP-certified manufacturer:
- Maintains validated production processes and controlled environments.
- Tracks materials and batches for full traceability.
- Ensures consistency, purity, and safety across every lot.
This standard is mandatory for pharmaceutical manufacturers and increasingly expected in nutraceutical production as well.
2. FDA GRAS
GRAS (Generally Recognized As Safe) is an FDA designation confirming that the raw materials used in capsule production are proven safe for human consumption.
In the case of empty capsules, this includes gelatin derived from bovine hide or plant-based hydroxypropyl methylcellulose (HPMC).
Manufacturers using GRAS-approved materials demonstrate adherence to toxicological safety and scientific transparency, reducing regulatory hurdles during formulation approval.
CapsCanada, for instance, ensures our raw materials meet FDA GRAS-approved capsule materials, which confirms full compliance with U.S. safety standards.
3. Halal and Kosher Certifications
Halal and Kosher certifications validate that a capsule’s raw materials and manufacturing process comply with Islamic and Jewish dietary laws, respectively.
While both emphasize purity, cleanliness, and traceability, their requirements differ in how raw materials are sourced and handled.
For example:
- Halal prohibits porcine derivatives and alcohol at any stage of production.
- Kosher enforces segregation between dairy and meat-derived materials and requires rabbinical supervision.
Dual certification allows capsule manufacturers to meet the needs of culturally and religiously diverse markets while guaranteeing integrity in sourcing and processing.
Understanding the difference between Halal and Kosher certification helps global manufacturers ensure inclusivity and access across diverse markets.
4. Non-GMO Certification
A Non-GMO label certifies that none of the materials used in capsule production have been genetically modified.
In capsule manufacturing, this reinforces clean-label integrity and traceable sourcing, both of which are key to consumer trust and compliance in the European and North American nutraceutical markets.
5. BSE- and Prion-Free
Bovine Spongiform Encephalopathy (BSE), commonly known as mad cow disease, led global regulatory agencies to implement strict controls on animal-derived ingredients.
A BSE- and prion-free certification guarantees that the gelatin used in capsule production comes exclusively from healthy, inspected animals, and from regions where BSE is not present.
This certification ensures full compliance with WHO, EMA, and Health Canada standards, safeguarding both consumers and international supply chains.
6. The Vegan Society Registration
Capsules registered with The Vegan Society contain no animal-derived materials, are not tested on animals, and are produced under strict cross-contamination controls.
This certification, available for HPMC capsules, allows manufacturers to use the Vegan Trademark, a globally recognized symbol of ethical production.
7. Fair Trade
Although traditionally associated with agriculture, Fair Trade certification is gaining importance in the pharmaceutical and nutraceutical supply chain.
It validates fair labor conditions, responsible sourcing, and environmental stewardship across suppliers and partners.
For capsule manufacturers, Fair Trade reinforces ethical standards in raw material procurement.
CapsCanada: A Certified Partner You Can Rely On
All CapsCanada capsules, including G-CAPS® (gelatin) and K-CAPS® (vegetarian HPMC) are produced under:
- cGMP manufacturing standards
- FDA GRAS-approved raw materials
- Halal and Kosher certification
- Non-GMO, BSE- and prion-free compliance
- The Vegan Society registration (for K-CAPS®)
- Fair Trade-aligned sourcing principles (EU)
These certifications ensure the safety, integrity of every capsule and also transparency across the entire supply chain, from raw materials to global distribution.
Ready to Discuss Your Next Project?
Certifications are the language of trust in today’s nutraceutical and pharmaceutical industries. They confirm that a product is safe, traceable, compliant, and ethically produced, and that every step in its creation can stand up to regulatory and consumer scrutiny alike.
If you want to ensure your formulations meet these same global standards, contact a CapsCanada expert to discuss your next project.
