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CAPA Process Steps in Pharmaceutical Industry
Each pharmaceutical manufacturer shall establish and maintain procedures for implementing corrective and preventive action (CAPA). And the procedures must ensure all requirements of CAPA subsystem are met. CAPA Subsystem in Context CAPA Process CAPA Sources Internal Sources External Sources CAPA Process Steps 1. Analyze Data Ensure all quality data sources ... Read More
Subpart of 21 CFR Part 211
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. FDA 21 CFR Part 211 covers the areas for finished drug products, such as labeling, production processes, equipment management and ... Read More
Microbiological Data Integrity Issues and Control Strategies
Microbiology lab is manual process based lab, less automation than chemistry lab, less regulatory guidance for microbiologist so that DI issue is the major concern in Microbiology lab. The sterility test, the bacterial endotoxin test and microbial enumeration test which involves counting microbial colonies are mostly prone to DI issues. ... Read More
Deviation in Pharmaceutical Industry
It causes a big confusion to understanding the occurrence of incidence and deviation in pharmaceuticals. In this article we briefly discuss on types of deviation and management of deviation. Deviation Terminology When we have any written procedure like standard operating procedure, protocol, standard test procedure, BMR etc. and someone works ... Read More
Contamination Control Strategy (CCS) for Pharmaceutical Industry
Defining a well-documented cross-contamination strategy involves several key steps. When defining a CCS (contamination control strategy), it is recommended to consider not only cross-contamination but also all other types of contaminants. While the majority of available guidance (e.g ECS, PDA, Annex-1 of EU GMP) primarily focuses on parenteral preparation, it ... Read More
Introduction to Pharma Digests
Welcome to pharmadigests.com! This is an introductory post of pharmadigests.com. Here we try to introduce the site with our happy readers. This is an educational website for pharmacy students, pharmacy professionals, and healthcare providers. Our aim to publish quality contents with comprehensive information on different areas of pharmacy and pharmaceutical ... Read More