Quality

Quality without Compromise!

 

Our high level of quality is the result of much effort, planning and professional execution.
 
Our professional and experienced quality assurance department is committed to the strictest Israeli and international procedures and regulations in order to deliver the results at an uncompromising quality standard.
 
We hold the following certifications and licenses:
 
  • GDP and GMP permits.
  • Manufacturer / Importer Certificate (MIA).
  • General license for cosmetics.
  • Permits for the storage and distribution of medicines, raw materials, cosmetics, medical devices, research products (IMP), food and nutritional supplements.
  • GDP permit, commercial and pharmacy permit for medical cannabis products.
  • License to import and treat radioactive products.
  • A licensed pharmacy specializing in direct delivery to the patient.
  • The facility was designed and constructed to comply with FDA and EMA standards.

 

In order to maintain high quality our controls are reflected in:

 

  • Storage in temperature- & humidity-controlled and monitored facilities using an on-line control system adapting to the storage conditions required for each material: 15-25°C, 2-8°C, -15°C (-20°C).
  • Distribution vehicles with temperature sensors: 15-25°C, 2-8°C.
  • Valid means of distribution according to the required storage conditions.
  • Loading and unloading in a cooling area to support biological drugs that require full cooling control throughout the process.
  • Information systems that comply with the requirements of 21 CFR part 11: Inventory management and orders, controlling and monitoring of temperature and humidity, Managed Document Managing (EDMS), managing changes in information systems (MIS), information system for managing equipment and structure.
  • Managing procedures through a valid information system as part of the quality system.
  • Authorization and training system for all company employees, including advanced learning systems.
  • Risk management for the FMEA (Failure Mode & Effect Analysis) to identify and locate risks and failure points and to define preventative actions.
  • A system for implementing repair and preventive actions (CAPA), following complaints investigations, inconsistencies, risk management, tests, findings of inspections by regulatory authorities and distribution partners, and trends arising from monitoring processes in a quality system.
  • Controlled packaging adjustment system according to GMP requirements.
  • A comprehensive security system to prevent theft and / or distribution of suspected counterfeit products.
  • Pesticide Control system, electronically monitored.