Manufacturing
Clean-in-Place in pharmaceutical Industry
CIP, or Clean-in-Place, is a critical process in the pharmaceutical industry, ensuring that equipment and systems are effectively cleaned without disassembly. Importance of CIP in Pharmaceuticals Key Components of CIP Systems Steps in a CIP Process Read also: Resource Person: Omar Salah
Basics of Tablet Tooling
Tooling can be defined as tools to craft a particular shape. Tableting tools i.e., Punches and dies are essential tools to shape any granules into a solid dosage form by applying compaction force in a compression machine. Any shape be it round, oblong or bullet shape or any special shape ... Read More
Purpose of Tablet Coating
Tablets are the most commonly used dosage form which are manufactured in Pharmaceutical Industries. Many tablets in pharma are coated and some tablets are uncoated. Tablet coating is the process where we apply a thin coat of film formers & related excipients over the tablet surface. REASONS FOR TABLET COATING ... Read More
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