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Quality

Certified quality, traceable to every batch.

Certified to ISO 9001 since 1996, and to ISO 15378, the GMP standard for producers of primary packaging materials for pharmaceutical products.

Quality lab and inspection
Certifications & Approvals

Recognized by the regulators that matter.

Our plants operate to cGMP, with Drug Master Files filed with the USFDA and Health Canada, so your regulatory submissions can move forward with a qualified supplier already on file.

ISO 15378
ISO 15378
Primary packaging GMP
ISO 9001
ISO 9001
Certified since 1996
USFDA
USFDA DMF
Drug Master File
Health Canada
Health Canada
Canadian DMF approved
USP / EP
USP / EP
Type I glass
cGMP
cGMP
Manufacturing practice
EcoVadis
EcoVadis
Silver rating, top 15%
Our Quality Team

A dedicated team, across every site.

Our Quality Team has grown with professionals drawn from the pharmaceutical industry, sharpening how we manage operational procedures, the quality manual, inspection audits and employee training across all three factories.

18
Quality Team members, across three factories
5
Lab resources, dispersed across our sites
1
Dedicated manager of Quality Assurance
5 yrs
Batch records retained after dispatch
Batch Traceability

Every lot, traced from raw material to dispatch.

Each product lot starts with a batch record within our business units, capturing every production variable that occurred during manufacturing. No two lots ever share the same number, and that unique number carries through the order confirmation, transport document, invoice, box label, pallet label, screen print film and certificate of lot clearance.

With this number, we can trace a batch's origin, its raw material, the start and end times of the production line, the operator and QC supervisor, the shift technician and the warehouse staff involved. At the end of production, we issue a lot clearance certificate listing every control carried out and its outcome.

Unique lot numbering

Every batch individually traceable, no number repeats.

Ongoing staff training

Every team member trained continuously and certified by QA.

Lot-clearance certificate

Issued with every shipment, listing all controls and outcomes.

Need Documentation?

Ask us for DMF letters of access or a sample certificate of analysis.

Contact our team