Steam sterilization and water shower sterilization are both methods used to sterilize equipment and materials, particularly in pharmaceutical manufacturing. Here’s a comparison between the two: Steam Sterilization – Process: Uses saturated steam under pressure to kill microorganisms. The steam penetrates the materials and transfers heat energy, which causes the coagulation of proteins, effectively killing…
In this post, we will know what the difference between AQUEOUS and NON-AQUEOUS film coating. First, we must know why we use aqueous, why we use non-aqueous, and why we do not use one type of for all products. Comparison between the two types in the process: Some notes Read also: Resource Person:…
Competitive generic therapy (CGT) and List Off-patent and Off-exclusivity are two important concepts that are often confused with each other. We will explore the main difference between these two concepts. Competitive Generic Therapy (CGT): NMT one approved drug in the active section of the Orange Book (RLD/Generic) + no unexpired patents or exclusivities listed…
Sterilization and depyrogenation are two different processes used in various industries, including pharmaceuticals and healthcare. Here are the differences between them: 1. Definition – Sterilization: Sterilization is the process of eliminating or destroying all forms of microbial life, including bacteria, viruses, fungi, and spores. – Depyrogenation: Depyrogenation is the process of removing or inactivating…
In the pharmaceutical industry, calibration, validation, and qualification are crucial processes that ensure the accuracy, reliability, and compliance of instruments, methods, and processes used in drug development, manufacturing, and quality control. While these terms may seem similar, they have distinct meanings and purposes within the pharmaceutical context. Calibration Calibration in the pharmaceutical industry refers…
Process and procedure are two important terms in quality management and ISO 9001 standard that are often used interchangeably. However, there are some key differences between the two terms. 1. Definition: – Process: A process is a set of interrelated or interacting activities that transform inputs into outputs. – Procedure: A procedure…
What is Regulatory Affairs? Professionals in this field implement regulations from local, state and federal governing bodies to ensure compliance. They also stay up to date on the latest policy changes and recommend new organization protocols as necessary. RA professionals work in Bio pharmaceutical, pharmaceutical and medical devices industries What is Quality Assurance (QA)?…
Introduction In September 2022, the U.S. Food and Drug Administration (FDA) released a draft guidance on software validation, introducing a new approach called Computer Software Assurance (CSA) for production and quality system software. This guidance marks a shift from the traditional method of software validation, known as computer system validation (CSV), towards a risk-based approach….
