The Quality Assurance & Environment Department is an independent function reporting directly to the executive board. LEF QA department assures the management of LEF Quality Systems, including
- Documentation system (Quality Policy, Quality Manual, Site Master File, SOP’s)
- Training and Qualifications of LEF’s staff
- Management of Qualification Maintenance and Calibration programs of facilities, utilities and equipment
- Internal Quality Assurance activities
At LEF, biological samples are analyzed in compliance with GLP - OECD guidelines. Preformulation, formulation and analysis of Pharmaceutical products are performed in compliance with GMP and all regulatory applicable guidelines and legislation.
As an EN ISO/IEC 17025 accredited laboratory, LEF participates in national and international proficiency tests (FIP, EDQM, RELACRE), covering all the analytical tests provided to the customers.
Services
- Quality Systems Development (GMP, GLP, ISO 17025 and ISO 9001)
- Technical support in quality procedures elaboration and implementation
- GMP, GLP, ISO 17025 and ISO 9001 Audits
- Training