RECORDS MANAGEMENT & DECOMISSIONING                                                                    

Stability Program & Storage



MGM offers a comprehensive drug stability program with FDA and ICH guidelines.

We can manage all aspects of your stability programs. MGM will develop a complete package according your needs:

Making up a protocol to client requirements, Store samples, perform analytical testing, make stability calculations, prepare interim and final reports and maintain stability tables.

All aspects of studies are completely monitored, whether testing is done by our lab or yours.

• Stability storage at typical ICH conditions

• Custom storage conditions

• Sample management during study

• Stability study protocol development

• Stability table preparation and maintenance

• Stability testing

Storage Conditions (typical ICH conditions)

• 25°C/60% RH

• 30°C/35% RH

• 40°C/<25% RH

• 40°C/75% RH

• Custom conditions, please ask!!