Pharmacy & Quality Assurance

SLE is a leading provider of logistics services for the pharmaceutical industry in Israel, specializing in quality assurance throughout the supply chain. We operate in full compliance with GDP requirements and the stringent standards established by global pharmaceutical companies whose products are managed and distributed through our facilities.

With over 125 years of accumulated experience and partnerships with more than 50 pharmaceutical, dermocosmetic, and medical device companies, we understand the critical importance of maintaining the highest levels of quality assurance at every stage of the supply chain.

Our Quality Assurance Department is staffed by licensed pharmacists who oversee, monitor, and audit all supply chain activities. Every process is supervised by experienced pharmaceutical professionals and supported by advanced technological systems that ensure compliance, traceability, product integrity, and operational excellence.

Quality Management System

Our Quality Management System includes:

• Standard Operating Procedures (SOPs) aligned with GMP and GDP requirements and compliant with the standards of global pharmaceutical companies
• GMP, MIA, and GDP certifications
• Authorizations for the handling of medical cannabis products
• Licensing for the storage and distribution of pharmaceuticals (finished products and raw materials), cosmetics, food and dietary supplements, medical devices, and Investigational Medicinal Products (IMPs)
• License for the importation and handling of radioactive materials
• Licensed pharmacy specializing in direct-to-patient services, including home delivery of medical cannabis
• Facility designed and constructed in accordance with FDA and EMA standards
• CFR 21 Part 11-compliant computerized systems
• Temperature-controlled storage facilities for:
  • 15°C to 25°C (Controlled Ambient)
  • 2°C to 8°C (Refrigerated)
  • -15°C to -20°C (Frozen)
  • Below -20°C (Deep Frozen)
• Temperature-controlled transportation fleet operating within 15°C to 25°C and 2°C to 8°C ranges
• Validated packaging solutions designed to maintain required storage and transportation conditions
• Internal audit program conducted by qualified auditors
• Successful completion of more than 30 annual audits and external quality inspections by global and local pharmaceutical companies, as well as regulatory authorities
• Controlled training and competency management program
• Change control management processes
• Ongoing risk management program for operational processes
• Periodic calibration and qualification activities in accordance with pharmaceutical industry standards

Full Control Throughout Storage and Distribution

SLE maintains continuous oversight of all storage and distribution activities, ensuring product quality and regulatory compliance until delivery to the customer.

Our control measures include:

• 24/7 continuous monitoring and recording of temperature and humidity throughout all storage areas
• Continuous temperature monitoring and recording during transportation, including real-time alerts for any deviations
• Qualification and validation programs for storage facilities, equipment, and computerized systems
• Periodic calibration activities performed according to pharmaceutical manufacturing standards
• Verification of imported pharmaceutical shipments for compliance with Israeli registration requirements and submission for QP batch release in accordance with Ministry of Health regulations
• Management of imported pharmaceuticals under Regulation 29(a)(3) of the Israeli Pharmaceutical Regulations
• Computerized systems for the management and documentation of quality complaints and medical complaints

By combining pharmaceutical expertise, advanced quality systems, rigorous regulatory compliance, and state-of-the-art technology, SLE ensures product integrity, patient safety, and the highest standards of quality throughout the entire supply chain.