by maheshbhuva | Dec 1, 2025 | Analytical Chemistry, Out of specification, Pharmaceutical interview,, Quality control (QC)
The OOS FlowchartPhase I: Laboratory Investigation(Did the Lab make a mistake?) [ START: OOS Result Detected ] | v[ Notify Supervisor Immediately...
by maheshbhuva | Jun 1, 2024 | Analytical Chemistry, Out of specification, Quality control (QC)
Scope Input Martial In process stage Finish product Stability Note : Not applied in process stage which give procedure Further operation (e.g like give option in BMR if result not found as per Limit and further go operation e.g CF drying sample) Purpose: Ensure that...
by maheshbhuva | Nov 3, 2023 | 21 CFR, Uncategorized
21 CFR stands for Title 21 of the Code of Federal Regulations. It is a set of regulations issued by the United States Food and Drug Administration (FDA) that covers various aspects of regulatory requirements for pharmaceuticals, medical devices, food, cosmetics, and...
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...
