The stability studies according to the Guideline ICH Q1A are a mandatory requirement of European Agencies for the approval of a new dossier. According to the climatic zones, to keep the medicinal products under different conditions is needed to evaluate their stability and to fix an expiry date.
What is needed for these studies?
For these studies qualified and calibrated climatic chambers as well as the GMP certification are necessary.
What Netpharmalab offers to you…
At Netpharmalab we offer the possibility to store the samples in the different climatic chambers as well as the analysis of these samples throughout all the ICH stability study (usually 60 months).
The different climatic chambers for these studies that we offer are:
- 25ºC/ 60% RH
- 30ºC/ 65% RH
- 30ºC/ 75% RH
- 40ºC/ 75% RH
In this way, the stability studies can be performed for different climatic zones (from Zone II to Zone IVb), as well as the possibility of carrying out stability studies of cold storage products, as we also offer the possibility of storage under controlled conditions of 5 ± 3ºC.
In addition, at Netpharmalab we prepare the protocols, the results summaries, the reports and the stability tables according to the GMP.