In the area of Quality Management, we specialize in advising and implementing Good Distribution Practice and Good Manufacturing Practice.
Range of services:
- organization and creation of quality structures in the enterprise,
- implementation of quality systems compliant with the requirements of GDP, GMP,
- development of documentation, procedures and instructions of the quality system compliant with GDP, GMP requirements,
- organization and conducting quality trainings in the field of quality systems, Good Distribution Practice,
- organization and conducting training for internal auditors based on GDP / GMP requirements,
conducting quality audits of the Quality System,
- development of risk assessment and validation procedures and qualifications for distribution processes, including warehouse space mapping methodologies and transport validation,
- preparation of quality agreements in accordance with the requirements of GDP and GMP,
- support in the interpretation and implementation of legal provisions in the field of pharmaceutical production and distribution, marketing of medicinal products, medical devices, foodstuffs.