In the pharmaceutical industry, both generic (ANDA) and 505(b)(2) submissions are key regulatory pathways, but they serve different purposes. Generic (ANDA): This is for drugs that are bioequivalent to an already approved product. ANDA submissions must show the drug is the same in dosage, form, strength, and administration route as the reference drug. No new…
Disinfection Sterilization Disinfection and sterilization have a few things in common. These include: Read also: Resource Person: Ch/Ahmed Mahmoud
Good Manufacturing Processes (GMPs) for Quality Assurance GMPs are the backbone of consistent and controlled production of products, meeting the required quality standards for their intended use. They cover both production and quality control, ensuring excellence in the manufacturing process. Good Clinical Practice (GCP) for Ethical Trials GCP sets the gold standard for designing,…
Purity Purity refers to the degree to which a substance is free from impurities or contaminants. In pharmaceuticals and chemicals, purity is a critical parameter because impurities can affect the safety, efficacy and stability of the final product. Purity is usually expressed as a percentage and can be determined through various analytical techniques such as…
RLD: An RLD is the specific listed drug on which an ANDA applicant relies in seeking approval for its ANDA. The ANDA applicant must show, among other things, that its proposed generic drug is the same as to the RLD with respect to the active ingredient(s), dosage form, route of administration, strength, labeling and conditions…
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…
1. Purpose: The user requirements specification document outlines the needs and expectations of the end-users or stakeholders, focusing on the functionalities and features required from a system or product. On the other hand, the design qualification document describes the design solution, including technical specifications and implementation details. 2. Content: A user requirements specification…
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…
