Quality assurance is the department that assures the quality of the drug product.
SOP for Disaster management for Chromatographic Software Data System Purpose: This procedure establishes a disaster management plan for handling any natural disaster or a human-made …
In Pharmaceutical, an Annual product quality review (APQR) is of high importance to summarize the product quality for an improvement or to know the product …
SOP for Handling Of Rejected Batches In Pharma Industry Every organization is having its own SOP on the handling of rejected batches. Let’s understand common …
Types Of FDA Inspections If the organization is manufacturing drugs or drug devices or it is the processor of the USFDA product, then the organization …
What is the full form of CAPA? What is CAPA in pharma? what is the difference between CA and PA? Such types of questions generally …
What Is Change Control process In Pharma? Change control is one of the change management processes in pharmaceuticals. Whenever it needs to change in the …
Drug Master File (DMF) is a confidential data provided by the manufacturer to the Food and Drug Administration (FDA) for review, before approving any product …
Background: Today here we are going to discuss Abbreviated New Drug Application (ANDA) in pharmaceutical and how ANDA has arrived in the industry. …
