Pharmaceuticals and Quality Assurance

 
SLE is a leading trading company that provides logistic services to the pharmaceutical & healthcare market with a quality assurance system in compliance with GMP / GDP requirements and to the standards of the global and local pharmaceutical companies, who distribute their products through us.

With more than 100 years' experience and collaboration with about 35 pharmaceutical, Dermocosmetics and medical equipment companies, we understand the importance of maintaining high quality assurance through all the supply chain stages.

Our quality assurance department is comprised of quality assurance teams who monitor all stages of the supply chain, using advanced technological systems for backup and control.

The Quality Management System includes:

 

  • Compliance system SOP's that meet the GMP / GDP requirements and the standards required by the global pharmaceutical companies.
  • GMP, MIA and GDP permits.
  • Permits for handling medical cannabis products.
  • License to store and distribute medicines (finished products and raw materials), cosmetics, food and nutritional supplements, medical equipment, research products (IMP).
  • License to import and handle radioactive products.
  • A licensed pharmacy specializing in direct delivery to patients, including medical cannabis supply to the patient's home.
  • A facility built in compliance with FDA and EMA standards.
  • A computerized system compatible with CFR 21 Part 11.
  • Controlled storage areas at 15-25°C, 2-8°C, (-15°C)- (-20°C), (<-20°C).
  • Vehicles with full temperature control: 15-25°C, 2-8°C.
  • Validated packaging for distributing products under the required conditions 15-25°C, 2-8°C, (-15°C)- (-20°C), (<-20°C) Internal assessments carried out by qualified inspectors.
  • Compliance undergoing more than 30 annual inspections and external quality assurance inspections by global and local pharmaceutical companies and regulatory authorities.
  • A supervised training system.
  • Change management controls.
  • Ongoing risk management system for processes.

All stages of storage and distribution are monitored until the order reaches the end-client

 

  • Temperature and humidity of storage areas are constantly monitored and recorded 24 hours a day.
  • Monitoring and recording of constant temperature during distribution, including real time anomalous alerts to the distribution center.
  • Validation processes for storage facilities, equipment and information systems.
  • Periodic calibrations according to the standards of pharmaceutical production sites.
  • Compliance checks with Israeli registration requirements and QP release submitted according to the Ministry of Health requirements for imported preparations' shipments.
  • Imported product control according to Regulation 29A3 of the Medical Preparations Regulations.
  • Managing a computerized system for controlling quality and medical complaints.