Current Good Manufacturing Practice regulations under 21 CFR 111 (supplements) and 21 CFR 211 (pharmaceuticals) require testing of finished products and incoming materials against established specifications. Our ISO 17025 accreditation pending laboratory provides analytical services formatted for integration into cGMP quality systems, batch records, and regulatory submissions.
cGMP regulations require that finished products be tested against established specifications before release. The testing lab must have documented methods, calibrated equipment, and a quality system — all captured in our ISO 17025 accreditation-pending framework.
Under 21 CFR 111.75 and 111.80, dietary supplement manufacturers must test finished batches against specification before release for distribution. Our COA satisfies the documentation standard.
21 CFR 111.75 also requires testing of dietary ingredients and other components — not just finished product. We accept raw material samples for ICP-MS, microbial, and identity testing.
Moisture content, water activity, and physicochemical parameters are part of the cGMP finished product specification. We test these parameters alongside analytical safety testing.
In-process testing at critical control points — blend uniformity, potency during granulation — requires rapid analytical support. We offer expedited in-process turnaround.
cGMP requires validated analytical methods for specification testing. We can provide method validation data and method transfer support for clients establishing in-house QC programs.
When FDA audits your facility, your COA from a certified lab is part of your batch records. ISO 17025 accreditation-pending COA demonstrates that your testing was conducted under a quality system.
Services for cGMP-compliant manufacturing:
Submitting takes less than 5 minutes. Most projects turn around in 5–10 business days from sample receipt.
Send a brief project description — sample type, quantity, and timeline. We confirm turnaround and quote within one business day.
We'll send a submission form and our San Diego shipping address. Most samples ship ambient or cold depending on stability requirements.
Results are delivered as a signed PDF COA within the agreed turnaround. Rush service (2–3 business days) is available for urgent timelines.
Send us your samples and receive an ISO 17025 accreditation pending Certificate of Analysis. Results in 5–10 business days.