We provide full ICH stability studies for third parties according to procedures previously agreed with the customer.
Theses studies may include: transfer and optimisation of methods, analytical standards management, storage in different climatic conditions, programming of analytical time points and full analysis.
Our services include:
- Stability studies in accordance with ICH guidelines in controlled temperature and humidity conditions (Zone I to IV).
- In-use stability studies.
- On-going stability.
- Accelerated studies.
- External management of stability.
Our stability chambers are certified and monitored via a system of alarms that constantly control theirhumidity and temperature.
We have the following temperature and humidity conditions:
- 25°C/60 % RH
- 30°C/65 % RH
- 40°C/75 % RH
- 30°C/75 % RH (climactic zone IV)
We have the following facilities and equipment:
- Aralab FitoClima 12000 PH Walk-in Temperature and Humidity Stability Chamber- (2 units).
- BINDER KBF-720 Climate Chamber (5 units).
- BINDER KWF-720 Climate Chamber (1 unit).
In short, we facilitate testing in relation to how the quality of the active ingredients or the drugs varies over time. We determine the useful life of the drug and the recommended storage conditions.
- Pharmaceutical Laboratories
Accreditations and Recognition
The Pharmaceutical Development Control Laboratory is certified by the Spanish Agency for Medicines and Healthcare Products (AEMPS) in Good Manufacturing Practice (GMP) guidelines: Physical and chemical quality control medicines for human use and medicines under research.
The manufacturing plant is certified by the Spanish Agency for Medicines and Healthcare Products (AEMPS) in Good Manufacturing Practice (GMP) guidelines: Manufacture and import of pharmaceuticals for non-sterile human use, including psychotropic and narcotic substances / Manufacture and import of non-sterile investigational medicinal products.
The drug manufacturing plant has been granted the ISO 13485 certification for quality management for the medical devices industry.