Our compliance posture in one place. Audit packages and signed certificates available under NDA — request from quality@premierlabglass.com.
Each item below is a live, current registration. Lapsed or pending items are not listed.
Registered QMS covering design, fabrication, anneal, inspection, and shipping. Annual surveillance audits by an accredited registrar.
Cert # available on requestVolumetric apparatus calibrated against NIST-traceable mass standards in our temperature-controlled bath. Cert ships with every Class A piece.
Calibration cert in boxDrug Supply Chain Security Act traceability for pharmaceutical container glass. Lot history, custody chain, and serialized records on every Type I order.
USP <660> Type I documentedRegistered with the U.S. Department of State Directorate of Defense Trade Controls (DDTC). Cleared for fabrication of items on the U.S. Munitions List under appropriate authorizations.
M-Code available under NDAPharmaceutical primary-container glass fabricated under CGMP-aligned procedures. Compatible with customer drug product manufacturing audits.
Audit-ready under NDAUSP General Chapter <660> Type I and Type III container glass produced and tested per pharmacopeial methods. Hydrolytic resistance class HGB 1.
CofA on every pharma lotCompliant with EU Restriction of Hazardous Substances and Registration, Evaluation, Authorization and Restriction of Chemicals. Lead-free glass throughout.
Compliance letter on requestFTC "Made in USA" qualified — all manufacturing operations performed in Toledo, Ohio. Substantially all material content sourced from US and qualified Allied suppliers.
BAA / TAA compliantActive registration in the System for Award Management. CAGE code on file. Eligible to bid on federal contracts and fulfill agency POs without intermediation.
UEI available on requestStandard documentation by piece type. Anything below not on the default list is available on request — flag it on the PO and we'll include it.
| Document | What it certifies | Standard / Optional |
|---|---|---|
| Certificate of Inspection (CoI) | Each piece passed dimensional, visual, and stress inspection | Standard · all orders |
| Calibration Certificate | NIST-traceable volume calibration to Class A tolerance | Standard · Class A volumetric |
| Material Test Report (MTR) | Glass composition and hydrolytic class from supplier lot | Optional · request on PO |
| Certificate of Origin (CoO) | Country of manufacture, BAA / TAA qualifying status | Standard · government & pharma |
| DSCSA Pedigree Record | Lot serialization and chain of custody for pharma container glass | Standard · USP <660> orders |
| USP <660> Compliance Letter | Type I or Type III determination per pharmacopeial method | Standard · pharma orders |
| Pressure-Test Record | Reactor or pressure vessel proof-tested to specified pressure | Standard · reactors / vacuum apparatus |
| EAR / ITAR Determination Letter | Export classification (ECCN or USML category) of the piece | Standard · international & controlled |
| Polariscope Annealing Record | Residual-stress reading from post-anneal verification | Optional · request on PO |
| RoHS / REACH Statement | Confirmation of compliant glass composition (lead-free) | Optional · EU orders |
Email quality@premierlabglass.com with your form or audit scope. Mutual NDA available on request. Customer audits welcome with two weeks notice.
We've been through the questionnaires before. Send the form and we'll have it back inside a week.