GMP
Certification Covers:
1.
Manufacturing Process Control
• Ensures that products are consistently produced
according to predefined quality standards.
• Covers everything from ingredient sourcing to
final packaging.
2. Ingredient Purity & Quality
• Verifies that raw materials meet identity,
strength, purity, and composition requirements.
• Helps prevent contamination, adulteration, or
mislabeling.
3. Facility & Equipment Standards
• Requires sanitary, well-maintained, and controlled
production environments.
• Covers equipment calibration, cleaning, and
maintenance procedures.
4. Personnel Training & Hygiene
• Ensures employees are trained in hygiene, safety,
and quality control.
• Establishes protocols to prevent
cross-contamination.
5. Quality Control & Testing
• Requires in-house or third-party lab testing of
raw materials and finished products.
• Checks for contaminants like heavy metals,
microbes, and unauthorized ingredients.
6. Record Keeping & Traceability
• Mandates proper documentation of ingredient
sources, production steps, and testing results.
• Ensures batch tracking in case of recalls or
audits.
7. Packaging & Labeling Accuracy
• Requires correct labeling of ingredients, dosages,
and usage instructions.
• Prevents misleading claims or misbranded products.
8. Complaint Handling & Recalls
• Establishes procedures for handling consumer
complaints.
• Ensures quick action if a product is found unsafe
or defective.
While the FDA enforces cGMP compliance, third-party
GMP certification adds an extra layer of trust and
transparency, especially for consumers looking for
high-quality supplements.
GMP certification does cover testing for
contaminants like mold, heavy metals, and other
impurities, but the specific requirements depend on
the certifying body (e.g., NSF, USP, NPA).
GMP Certification
& Contaminant Testing
1.
Microbial Contaminants (Mold, Bacteria, Yeast, etc.)
• GMP standards require testing for mold, bacteria,
yeast, and pathogens like E. coli, Salmonella, and
Staphylococcus aureus to ensure products are safe
for consumption.
• Testing methods include microbial plate counts,
PCR analysis, or other validated techniques.
2.
Heavy Metals (Lead, Arsenic, Mercury, Cadmium, etc.)
• Supplements must be tested for toxic heavy metals,
especially since plant-based or mineral-derived
ingredients can absorb these from soil and water.
• Common testing methods include ICP-MS (Inductively
Coupled Plasma Mass Spectrometry) to detect trace
amounts.
3.
Pesticides & Residual Solvents
• If botanical or plant-based ingredients are used,
GMP certification often requires screening for
pesticides, herbicides, and residual solvents from
extraction processes.
4.
Ingredient Identity & Purity Testing
• Ensures raw materials match the stated identity
and do not contain undeclared or adulterated
ingredients.
• Prevents contamination from allergens, toxins, or
counterfeit materials.
5.
Mycotoxins & Aflatoxins
• Some GMP-certified programs, such as USP and NSF,
require additional aflatoxin and mycotoxin testing,
especially in herbal supplements, grains, and nuts.
6.
Stability & Shelf-Life Testing
• Ensures the product maintains potency and does not
degrade before the expiration date.
