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.
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