- Development of analytical methods for drug substances and products
- Pharmaceutical investigations in accordance with international pharmakopoes
(e.g. Pharm.Eur., USP, BP) - Validation of analytical methods corresponding to Note For Guidance On Validation
Of Analytical Methods/Procedures - Stability testing of drug substances and products corresponding to Note For Guidance
On Stabilty Testing - In-use stability testing of human medicinal products (CPMP)
- Stability testing of biotechnological/biological products corresponding to Note For
Guidance On Quality Of Biotechnological Products - Storage of drug substances and products in climatic zones I to IV and under accelerated
conditions (CPMP/ICH) - Photostability testing of drug substances and products (CPMP/ICH)
- Identification and isolation of degradation products and impurities in drug substances
and products. - Biopharmaceutical testing of drug products according to Guidance for Industry
- Analytical testing and confirmation in accordance with §14 AMG (signed by head of
quality control, AMG) - Analytical release of starting materials for GMP-manufacturing (API, excipients,
intermediate products if appropriate) - On-going stability testing under GMP-conditions
- Accompanying analytical testing for validation of manufacturing processes
- Container Integrity-test
