Pharma Blog
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
Regulatory Guidelines for CSV
Embarking on the path to a successful Computer System Validation (CSV) roadmap begins with a solid understanding of the applicable regulatory requirements within your industry and region. Investing the time to understand which regulations you must comply with, which are advantageous, and which, are the gold standard, is a crucial ... Read More
Inadequate Investigations: A Common Observation by the FDA
During cGMP inspections, one of the most commonly cited observations by the FDA is the inadequate investigation into deviations. Pharmaceutical companies must address this issue to maintain compliance and ensure patient safety. Here are some key points to keep in mind regarding deviation investigations in the pharmaceutical industry: Observation Highlight ... Read More
Quality by Design (QbD) in Pharmaceutical Development
Quality by design (QbD) is a scientific and risk-based approach to pharmaceutical product development that begins with predefined objectives. Instead of relying on finished product testing alone, QbD ensure the product quality throughout the development process. Objective of QbD Approach Elements of QbD QbD comprises different elements of pharmaceutical development ... Read More
Basic Guideline for Prometric Examination (UAE)
Prometric exam is a world’s most recognized licensing and certification organization. In this article we discuss on the medical professional licensing way in UAE throgh prometic examination. There are 3 types of license available in UAE for medical professional: 1. The Ministry of Health, UAE (MOH) 2. Dubai Health Authority ... Read More