• 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

Contract GMP-laboratory of the service center of L.B. Bohle Maschinen + Verfahren GmbH represented as L.B. Bohle-Formula Pharmaceutical Services GmbH,
www.lbbohle-formula.de