LEF’s experience in several areas as led to a body of knowledge which we share with our clients and partners, supporting the implementation and management of Quality Systems, including customized training sessions.
- Quality Systems Development, in accordance with GMP, GLP, GDO, ISO 17025 and ISO 9001 requirements;
- Preparation for regulatory inspections and clients audits;
- Development of customized training programs (GXP and ISO standards);
- Internal audits for GMP, GLP, GDO and ISO regulations compliance;
- APIs’ Suppliers, finish product manufacturers, excipients manufacturers and packaging materials suppliers audits according to:
- Consultancy for validation (cleaning, manufacturing processes and analytical methods);
- Preparing the Site Master File and other GXP documents.
LEF has also two new services available to Pharmaceutical Industry customers: PDE Determination (Permitted Daily Exposure) and Risk Analysis of the Elementary Impurities. Both services aim to support customers in order to ensure compliance following regulatory changes.
Determination of PDE, in the prevention of cross-contamination in shared facilities, should be based on a scientifically substantiated assessment by determination of the PDE toxicological parameter.
Element Impurity Risk Analysis aims to ensure that the levels of elemental impurities present in the finished product do not exceed established limits.