Pharma Digest
Difference Between Quality Control (QC) and Quality Assurance (QA)
Quality control and quality assurance are two essential concepts that help ensure the safety and quality of the finished products. While both concepts share the same goal of maintaining high standards, they approach this goal in different ways. Quality control involves inspecting and testing products at various stages of production ... Read More
In-Process Control Procedure in Pharmaceutical Industry
IPC are checks that are carried out during manufacturing process running and/or before the manufacturing process is completed. The function of in-process controls is in-process monitoring in order to comply with the specifications. This may include control of equipment and environment too. In-process materials should be tested for identity, strength, ... Read More
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
Difference Between Calibration and Qualification
A list of differences between calibration and qualification are mentioned below: Similarities Read also:
Coating Process in Pharmaceutical Industry
Although both sugar coating and film coating are utilized by a significant number of pharmaceutical companies worldwide, the film-coating process is the one most often preferred today. Film coating was formally introduced into the pharmaceutical industry in the middle of the last century. It should be noted that there has ... Read More
Frequently Asked Questions and Answers on cGMP
Q1. Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or other file? The CGMP regulations for finished pharmaceuticals require the retention of cleaning and use logs for non-dedicated equipment. But no similar requirement exists for retaining what are intended to ... 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
ICH Quality (Q) Guidelines and Their Relevance to Pharmaceutical Manufacturing
In this article we discuss on ICH Quality (Q) Guidelines and their relevance to different phases of drug development and manufacturing. ICH Q1A(R2) – Stability Testing of New Drug Substances and Products This guideline provides recommendations on the stability testing of new drug substances and products, including the design of ... Read More
Difference Between Out of Specification (OOS) and Out of Trend (OOT)
OOS and OOT are two common terms in pharmaceutical quality control laboratory. In this article we mention the similarities and differences between Out of Specifications (OOS) and Out of Trend (OOT) Similarities between Out of Specifications (OOS) and Out of Trend (OOT) a. Both OOS and OOT are conducted in ... 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
Compression Process in Tablet Manufacturing
Compression or compaction is the pharmaceutical unit operation of applying pressure or force to the powder to densify it and generate the physical bonds between the powder particles. The critical parameters of this operation are (1) the material properties of the particles being compacted and (2) the equipment used for ... Read More