INVIMA ISSUES A PROJECT FOR MEDICINES STERILIZATION PROCESSES
INVIMA issued the project regarding sterilization processes for medicines. This was issued to reply the reports of microbiological contamination in sterile products which are considering a risk in public health
This project reminds to holders, manufacturers and importers of sanitary of sterile medicines the different requirements that must be complied for the sterilization processes (heat, filtration and/or radiation).
Additionally, it establishes a series of terms and requirements for the compliance of provisions in resolution 1160 of 2016 of sterile chemical synthesis medicines, which will come into force as of April 9th 2021. On the other hand those applications filed after of April 9th 2021 must submit the method of sterilization.