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
booklet labels.

• 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.

Validated equipment

• 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.

Resources:
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