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Introduction In September 2022, the U.S. Food and Drug Administration (FDA) released a draft guidance on software validation, introducing a new approach called Computer Software Assurance (CSA) for production and quality system software.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….
GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) are both quality assurance systems that are crucial in the pharmaceutical manufacturing industry. While they share some similarities, there are also notable differences between the two concepts. Standards: 1. GMP: GMP focuses on ensuring that pharmaceutical products are consistently produced and controlled according to quality…
RABS (Restricted Access Barrier System) and isolators are both important containment systems used in pharmaceutical manufacturing to protect products from contamination and ensure operator safety. Let’s take a closer look at their specifications, applications, and qualification tests. Specifications – RABS: RABS is a semi-closed system that creates a physical barrier between the operator and…
Inspection and audit are two distinct processes used to assess compliance with various guidelines and standards, including ISO 9001, FDA, EMA, and others. Here’s a breakdown of the key differences between inspection and audit based on these guidelines: Purpose: – Inspection: Inspections verify compliance with specific regulations or guidelines, focusing on identifying non-compliance issues…
Analytical Instrument Qualification (AIQ) and system suitability testing (SST) are both important processes in the pharmaceutical industry that ensure the accuracy, reliability, and consistency of analytical instruments used for testing drug products. However, there are some key differences between these two processes. 1. Purpose: – AIQ: The primary purpose of AIQ is to establish…
Ever wondered about the difference between a completely new drug (NDA) 505(b)(1)and a hybrid drug (NDA)505(b)(2)? Let’s explore the contrast between these two pathways! A 505(b)(2) New Drug Application (NDA) is a regulatory pathway in the United States that allows for the submission and approval of certain new drug products. The name “505(b)(2)” comes…
