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…
Black Spots Black-colored specks or dots on the tablet surface. Causes of Black Spots: Remedies for Black Spots: Inconsistent Thickness Variations in the tablet thickness within a batch or across different tablets. Causes of Inconsistent Thickness: Remedies for Inconsistent Thickness: Hardness Variation Inconsistency in tablet hardness across a batch or within…
Mottling Uneven distribution of color or pigmentation on the tablet surface. Causes of Mottling: Remedies for Mottling: Flashing It presents as a thin, unwanted edge around the perimeter of a tablet. Causes of Flashing: Remedies for Flashing: Chipping Breakage of tablet edges, resulting in small chips or fragments….
1. Capping Partial or complete separation of a tablet’s crown or upper portion from the main body. Causes of Capping: Remedies for Capping: 2. Lamination Tablets split into layers or laminates. Causes of Lamination: Remedies for Lamination: 3. Sticking It happens when the tablet material adheres to the punches and dies instead…
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,…
Process capability measures the inherent variability of a stable process that is in a state of statistical control in relation to the established acceptance criteria. Calculations based on the inherent variability due to common cause of a stable process (i.e., in a state of statistical control) result in process capability (Cp and Cpk) indices….
Introduction In September 2022, the U.S. Food and Drug Administration (FDA) released a draft guidance on software validation, introducing a new approach called Computer Software Assurance (CSA) for production and quality system software.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….
The knowledge gained through appropriately designed development studies culminates in the establishment of a control strategy. As shown in the picture, control strategy could include three levels of controls as follows: Level 1 utilizes automatic engineering control to monitor the CQAs of the output materials in real time. This level of control is the…
