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…
Innovator An innovator in the context of drugs refers to the original developer or manufacturer of a new pharmaceutical product. – Example: Astellas is the innovator of Veozah, as they researched, developed, and brought the drug to market first. Generic Drug Generic drugs are generic versions of a pharmaceutical product that are approved as…
Similarities 1. Both aseptic and terminal sterile manufacturing processes aim to prevent contamination of pharmaceutical products. 2. Both processes require strict adherence to Good Manufacturing Practices (GMP) guidelines. 3. Both processes involve the use of specialized equipment and facilities to maintain a controlled environment. Differences 1. Aseptic manufacturing involves the use of aseptic techniques,…
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….
