The stability of the finished products must be monitored according to a suitable and continuous program which will allow to detect any instability issue (e.g. changes in the impurity levels).
The purpose of the ongoing stability studies is to monitor the behaviour of the active substance and determine that it remains within specifications under the storage conditions of the labelling within the re-analysis period in all future batches.
At least, one production batch per year must be added to the ongoing stability program (unless it is not manufactured during the year) and it must be tested at least annually in order to confirm its stability.
In some cases, additional batches must be added in the ongoing stability program (e.g. after any significant change or significant deviation in the manufacturing process or in the container closure system that may impact the stability of the finished product).
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 according to the ongoing stability protocol.
The different climatic chambers for these studies that we offer are:
- 25ºC/ 60% RH
- 30ºC/ 65% RH
- 30ºC/ 75% RH
In addition, at Netpharmalab we prepare the protocols, the results summaries, the reports and the stability tables according to the GMP.