The guide was published on August 25, 2022. It is aimed at aseptic and sterile manufacturers of medicinal products for human and veterinary use and elevates the quality standards and analytical requirements for laboratory services. After a one-year transition period, it now comes into force on August 25, 2023, and defines significantly more stringent requirements for the following aspects:
- Quality assurance and quality management system
- Production and technologies
- Supply systems
- Facilities and equipment
- Environmental and process monitoring
- Qualified personell
We at Labor LS are happy to support you in the implementation and execution of qualification projects and laboratory services accoording to the latest GMP standards.