Validating environmental scan
21-Feb-2020 07:03
The steam is used to heat the load and to provide the moisture needed for sterilization.
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These align process validation activities with a product lifecycle concept and the International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.
The earlier guidelines were developed before the elaboration of the new ICH guidelines.
