by maheshbhuva | Jul 25, 2023 | Glassware
In the pharmaceutical industry, glassware is also classified based on its quality and accuracy, much like the Class A and Class B classifications commonly used in laboratory glassware. The classification of glassware in pharma is typically based on standards set by...
by maheshbhuva | May 20, 2023 | stability
Here both are the different Accelerated stability testing only 40°C/75 RH Study here time period are 1,3,6,12 Each batch perform Accelerated stability study Here we have to seen that naturally degraded drug product which is covered  According to WHO guidelines...
by maheshbhuva | May 18, 2023 | Hplc
Phosphate buffer Citrate buffer Formate buffer Acetate buffer Tris(hydrixymethyl) -aminomethane Phosphate buffer Pka 2.1 Ph range 1.1 tob3. 1 Pka 7.2 Ph range 6.2 to 8.3 Pk 12.3 Ph range 11.3 to 13.3 Citrate Pka 3.1 Ph range 2.1 to 4.1 Pka 4.7 Ph 3.7 to 5.7 Pka 5.4 Ph...
by maheshbhuva | May 3, 2023 | 483 observation, Analytical Chemistry, Out of specification
Do we need to raise an OOS, if OOS result is observed during API Method transfer First defined which lab mean by At receiving lab At originating lab YES Required Caution: inform API vendor about failure Investigation release analysis Assess impact on DP(drug product)...
by maheshbhuva | Apr 9, 2023 | Deviation, Documents error (DIN), QMS
Why investigation? To identified error  Random error Impacts precision (Weight error dilution  error injection to injection error Example document error, document error [ note : Precision show random error which is not control for us] +- positive and negative error...
