Supported by graduates and PhDs, NextPharma centres of excellence for analytical services provide services in the development, optimisation and validation of new analytical methods, regular analytics, and stability studies according to ICH guidelines.
NextPharma guides customers' projects through all phases of analytics:
- Development and validation
- Documentation for registration purposes
- Storage of stability batches in different climatic zones (according to ICH guidelines plus customer-specific related conditions)
- Stability testing
- Quality control of raw materials, bulk and finished products
The centres of excellence provide a high level of flexibility for development projects.
NextPharma has been providing microbiological services at its Göttingen facility for over 50 years. A major investment was undertaken in 2010, including the addition of five new laboratory rooms equipped with state-of-the-art air handling, laminar-flow benches and temperature-controlled incubators. The department is compliant with GMP, and all microbiological tests are performed and validated according to the required pharmacopoeia. The team provides a comprehensive range of services in microbiology and hygiene, including GMP-compliant environmental monitoring, hygiene training at customers facilities and compilation of hygiene plans.
The services include:
- Microbiological testing of non-sterile products
- Testing of purified water and raw materials
- Preservative effectiveness tests
- Tests for endotoxins
- Hygiene monitoring in production areas
- Training in advanced hygiene techniques
- Compilation of hygiene plans