Manufacturing
Basics of Line Clearance in Pharmaceutical Industry
Line clearance is an essential process in the pharmaceutical industry to ensure the safety and quality of products being manufactured. It involves a thorough inspection and verification of equipment, facilities, and materials before starting a new batch production or after completing a batch. The 3 C’s of line clearance, which ... Read More
Cleanroom Behavior in Pharmaceutical Industry
Cleanroom Behavior is a crucial aspect in preventing contamination in manufacturing areas. Operators must adhere to specific cleanroom behaviors, including the following practices: Slow and Deliberate Movement Operators should move carefully to minimize air turbulence, which can lead to particle generation or shedding. This principle should be observed throughout the ... Read More
Overall Equipment Effectiveness (OEE)
Its importance in manufacturing, its components, and how it can be used to enhance production processes. The Importance of OEE OEE is a crucial metric for measuring the performance of a manufacturing process. Evaluating a production line’s overall efficiency provides actionable insights that can help companies identify bottlenecks, reduce waste, ... Read More
Risk Analysis and Containment Solutions for High Potent APIs (HPAPIs) Manufacturing
The development of technical solutions for this new approach to containment must necessarily start from embracing the same approach to the topic used by the pharmaceutical companies, and adopt the very same risk analysis principles used in the industry to ascertain the hazards for each and every product, from OEB ... Read More
High Potent APIs (HPAPIs) | Challenges in Development and Manufacturing
Highly potent active pharmaceutical ingredients (HPAPIs) are pharmacologically active substances that exhibit biological activity at extremely low concentrations, such as daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of < 10 μg/m3 at an eight hour time-weighted average. Each HPAPIs have specific OEL that must be ... Read More
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
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