Facts About the Current Good Manufacturing Practices
The Food and Drug Administration (FDA) regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing…
Tag: Paid Manufacturing Course
SOP for Cleaning and Sanitization of Drain Traps
This SOP is applicable for cleaning and sanitization of drain traps. What will you learn In this course, you will learn about stepwise procedure of…
Guidelines on Recall and Rapid Alert System for Drugs
The CDSCO guidelines is applicable to all quality defective product reports. all reported incidents of safety and efficacy received for all drugs including vaccines &…
USFDA Inspection Form 482, Form 483 & Form 484
During an USFDA inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in…
Why Does USFDA Issues Warning Letter?
United States Food and Drug Administration (USFDA) issues a warning letter to a manufacturer or pharma company that has violated some rule in a federally…
IND, NDA & ANDA Drug Evolution Process
Drug evolution process is a novel concept proposed to develop chemical libraries that have a high probability of finding drugs or drug candidates. It converts…
HVAC System Validation Tests
Validation of HVAC System includes compiling documents of design, drawing of the design and its plan, Master plan of the validation process, TAB – testing,…
Implementation of Lean Six Sigma in a Pharma Company
The six sigma quality improvement theory allows continuous improvement in business. This process is so composite, businesses will require a flexible systems that will allow…
SOP For Operation And Cleaning of The Automated Friabilator
Automated Friability can be used to measure efficiency of tableting equipment or as an indicator of formulation suitability as well as routine QC functions. What…
SOP For Determination of Shelf Life of Solution in Laboratory
Shelf life and the limited useful life of compounded pharmaceuticals are no longer than 2 months. As with pharmaceutical compounding, a limited period of use of…