What is a Deviation in pharmaceuticals?
What is a Deviation in pharmaceuticals? Managing deviations is one of the most important aspects of pharmaceutical manufacturing. Defining deviation as a departure from written …
Quality Assurance
Quality assurance is the department that assures the quality of the drug product.
SOP for Disaster management for Chromatographic Software Data System in pharma
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 …
What is Annual Product Quality Review (APQR) in pharma?
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 the pharmaceutical industry
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 …
What are the 4 types of FDA inspections?
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 …
CAPA Process In Pharmaceutical Quality Management System
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?
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 …
What is Drug Master File (DMF) and types of Drug master file in pharmaceutical
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 …
Understand the Abbreviated New Drug Application in Pharmaceutical
Background: Today here we are going to discuss Abbreviated New Drug Application (ANDA) in pharmaceutical and how ANDA has arrived in the industry. …