Quality Control

Quality Control is an integral part of the manufacturing process. Dr. Korman Laboratories Ltd.'s Quality Control includes:

  • Inspection of incoming materials from suppliers to ensure compliance with our standard procedures and material specifications.
  • In-process inspection of all stages of the production processes, as well as batch release analytical and microbiological testing to ensure compliance with product specification. A list of performed tests is as follows:
    • Bacterial Endotoxin
    • Sterility
    • Visual examination
    • pH
    • Osmolality
    • Fill volume inspection
    • Viscosity
    • Extrusion force
    • Quantification of  main ingredients (such as Sodium Hyaluronate, Calcium Hydroxyapatite)
    • Detection of allowed limits in certain ingredients (such as 1,4-Butanediol diglycidyl ether)
  • A final inspection is performed after the packaging and labelling stage, whereas the batch record is released to the market when all inspections, result tests and records are fully compliant and meet the acceptance criteria.

All production and distribution records allow backward and forward traceability of the products.

Dr. Korman Laboratories Ltd.'s manufacturing premises are designed, built, maintained and certified through periodic monitoring and validation, to comply with EUGMP Class 5 clean room.

Regulation

Dr.Korman Laboratories Ltd.'s quality system is certified according to ISO 9001:2008, ISO13485:2003 and EN/ISO 13485:2012.

The dermal fillers in the concentrations 18 mg/ml, 23 mg/ml and 26 mg/ml are 93/42/EEC approved. The 12mg/ml dermal fillers as well as the bio- revitalization products are pending CE approval.

CONTACT US

Yosef Levi 23 Str.,
Kiryat Bialik, 2751123 Israel

Tel.: +972-(0) 46893930
Tel.: +972-(0) 46893931

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

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