Pharma Digest
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
Blending Process in Pharmaceutical industry
Blending or Mixing are the reorientation of particles relative to one another in order to achieve uniformity. Types of Blending Operating Principles of Blending Diffusion Blending (Tumble) Particles are reoriented in relation to one another when they are placed in random motion and inter particular friction is reduced as the ... Read More
Difference Between GMP and cGMP
GMP and cGMP are two common terms in pharmaceutical manufacturing. In this article we try to find out the differences between GMP and cGMP in pharma industry. “c” in cGMP “c” in cGMP stands for current, requiring companies to use technologies and systems that are up-to-date in order to comply ... Read More
Milling Process in Pharmaceutical Industry
Milling is a mechanical process of breaking particles into smaller pieces via one or more particle size reduction mechanisms. Types of Milling Milling Operation Principles Milling Equipment Classifications 1. Fluid Energy Mills Fluid energy mill subclasses have no moving parts and primarily are distinguished from one another by the configuration ... Read More
Granulation Process in Pharmaceutical Tablet Manufacturing
Granulation is the process of creating granules. The powder morphology is modified through the use of either a liquid that causes particles to bind through capillary forces or dry compaction forces. Importance of Granulation in Pharmaceutical Industry The granulation process will result in one or more of the following powder ... Read More