cGMP MEDICAL LABELING
Medical companies must carry “pages” of patient instructions, technical information, multilingual text, and FDA required copy on a variety of containers and product packages. It doesn’t matter if it’s a bottle, vial, box, syringe, bag, or unusually shaped product, we can label it.
JH Bertrand has the capabilities to make booklet labels following a robust QA system based on the FDA’s CFR 210 & 211. We follow the cGMP standard. However, please be clear that we are not licensed by the FDA as we are a label manufacturing facility, not a drug manufacturing/packaging plant.
OUR CGMP QUALITY TOOLS – The basis of our quality program is exactly matching your specifications with zero defects.
• Follow cGMP standards as based on FDA’s CRF 210 – 211.
• Strong Protocols for file handling.
22 security cages discreetly labeled for confidentiality.
• Machine vision on label inspection equipment with specialized software oriented toward
• Software check of artwork preparation to insure that the proof to be submitted matches
customer supplied original file.
• Computerized verification of customer approved proof against our printing proof.
• Computerized verification of the signed off proof against a printed booklet sample.
• OCR verification of printed codes against customer supplied CSV or Excel files.
• Quality pulls following higher level ANSI standard.
• Production teams wear scrubs/head protection during manufacturing for cleanliness and professional reasons
• Video surveillance of the entire facility for security.
• 100% bar code and missing label verification.
• Professional shredding contract to destroy job waste.
• Partitioned rooms for manufacturing control.
• Manufacturing in “lab” like conditions.
• Active pest control program.
• Rigorous Line Clearance procedures.
• Strict adherence to Quality SOPs.
• Active training program.
• Additional storage-locked and controlled.
• Treated certified pallets.
JH Bertrand has clients in the pharmaceutical, clinical drug, medical device, biotechnology, dental, and medical chemical industries.
PDF brochure gives overview of our medical products division.
PDF’s best viewed at 100%.
Multilingual Labeling for Limited Space Containers
We Want to Partner with Your Medical Printer
JHB’s Medical Ad