by maheshbhuva | Jun 6, 2023 | Analytical Chemistry, Job in pharmaceutical companies, stability
In the pharmaceutical industry, a “finished product retest” refers to the process of evaluating a sample from a previously manufactured and packaged pharmaceutical product to assess its quality, safety, and efficacy. The purpose of the retest is to ensure...
by maheshbhuva | May 22, 2023 | stability
Accelerated testing Increase the rate of chemical or physical change of drug product by using exaggerated condition as part of formal stability study. Intermediate testing conducted as at 30°C/65% designed to moderately increase the rate of chemical or physical...
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 | 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...
by maheshbhuva | Apr 6, 2023 | 621 USP CHAPTER
Adjustment of Mobile Phase Adjustment in composition of the mobile phase Adjustment ph of the aqueous component of the mobile phase Adjustment in concentration of salts in the buffer component of a mobile phase Adjustment in composition of the mobile phase Minor...
