Trends of the Pharmaceutical Industry is changing with huge pace and there is strong need of creating the Quality Assurance who has acquired skills in all dimensions so as to combat and sustain in this highly volatile environment with high level of competition. In this article we will ten discuss such skills which are the need of time.
There are various calculation and formulas required for the Calculation of MACO (Maximum allowable Carry Over), PDE (Permitted Daily Exposure) and NOEL (No Observed Effect Level) in Cleaning Validation. All these formulas are helpful in implementing the correct cleaning validation matrix and plan at facility. Herewith are detailed full proof […]
USP chapter 〈1790〉 titled ‘Visual Inspection of Injections’, is the most efficient document that describes every single aspects which should be taken care while performing the validation of visual inspection process for the sterile injectables.