Pharma Digest
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
Validation and Qualification In Pharmaceutical Manufacturing
What is Validation? As per EU GMP – It is “Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to expected results. What is Qualification? Comparison between Qualification and Validation Why Validation? What to Qualify/Validate? ... Read More
GMP in Pharmaceutical Industry
GMP stands for Good Manufacturing Practices. It is a set of guidelines and regulations to ensure that pharmaceutical products are consistently produced and controlled to the quality standards appropriate for their intended use. This includes guidelines for the design, monitoring, and control of manufacturing processes, as well as quality control ... Read More
Patents and Exclusivity in Pharmaceutical Industry
Did you know that “patent” and “exclusivity” are two of the most commonly searched terms on the FDA website? Generics account for more than 80% of prescription drugs in the US, and that number continues to grow. With approaching patent expirations of several top selling prescription brand-name drugs, sponsors of ... Read More