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Reference project
Revalidation of analytical methods
A manufacturer of pharmaceutical products needs a revalidation of analytical methods for the approval of raw materials, after their supplier was changed.
EXCO is to provide formal and documented evidence that the chemical analytical methods of the manufacturer are suitable for their intended purpose and that they fulfil the requirements placed upon them.
Implementation
- Planning of method validation
- Executing preliminary tests
- Executing the actual validation in the laboratory
- Creating associated documentation (preliminary tests, validation plan, validation report)
Technologies used
- Gas chromatograph - flame ionization detector
- HPLC UV/VIS detector
- Software solution: Empower, ChemStation
Through successful synchronizing of the validation in the laboratory routine, our client could maintain their routine analysis without any delays.
Customer benefits
- The client receives validated methods, which are being used in daily practice.
- EXCO offers its client the expertise of qualified specialists, who work in line with the latest state of technology and GMP-relevant regulations.
Client
Pharmaceutical company, Mannheim