Industrial Pharmacy
A Comprehensive Comparison between ANDA (Generics) and Biosimilars
Composition ANDA (Generics): Biosimilars: Approval Process ANDA (Generics): Biosimilars: Manufacturing Challenges ANDA (Generics): Biosimilars: Regulation ANDA (Generics): Biosimilars: Market ANDA (Generics): Biosimilars: Analytical Validation ANDA (Generics): Biosimilars: Process Validation ANDA (Generics): Biosimilars: Supply Chain ANDA (Generics): Biosimilars: Read also:
Basics of Tablet Tooling
Tooling can be defined as tools to craft a particular shape. Tableting tools i.e., Punches and dies are essential tools to shape any granules into a solid dosage form by applying compaction force in a compression machine. Any shape be it round, oblong or bullet shape or any special shape ... Read More
Purpose of Tablet Coating
Tablets are the most commonly used dosage form which are manufactured in Pharmaceutical Industries. Many tablets in pharma are coated and some tablets are uncoated. Tablet coating is the process where we apply a thin coat of film formers & related excipients over the tablet surface. REASONS FOR TABLET COATING ... Read More
FDA Non-Clinical Study Requirements for IND
Non-clinical studies are essential for assessing the safety and biological activity of an investigational drug before it is tested in humans. Here are the key aspects and requirements for non-clinical studies in an IND application: Pharmacology and Toxicology Information Non-clinical studies primarily focus on pharmacology and toxicology to evaluate the ... Read More
Administrative Modules and Submission of IND Application
The administrative module of an IND application includes essential forms and information that provide the FDA with details about the sponsor, the investigational drug, and the proposed clinical trials. Key components include: Submission The submission of an IND application involves several steps to ensure that the FDA receives all necessary ... Read More
Types and Components of Investigational New Drugs (IND) Application
An Investigational New Drug (IND) application is a request for authorization from the FDA to administer an investigational drug or biological product to humans. This application must be authorized before the interstate shipment and administration of any new drug or biological product that is not the subject of an approved ... Read More
CAPA Management in FDA Regulated Industry
A CAPA plan is a quality management strategy used in the manufacturing and production industries to identify and rectify defects to ensure they won’t repeat again in the future. Once a CAPA plan is implemented, it must illustrate ten objectives to meet the intent of the FDA 21 CFR 820.100 ... Read More
Product Quality and Performance Tests for the Microsphere Drug Products
Microparticulate systems such as microspheres, microcapsules, or any particle in a micrometer scale (usually of 1–1000 µm) are widely used as drug delivery systems, owing to their higher therapeutic and diagnostic performance compared to conventional drug delivery forms. These systems can be manufactured with many raw materials, especially polymers, most ... Read More
The Power of Root Cause Analysis | A Lifeline for the Pharmaceutical Industry
The pharmaceutical industry operates under a microscope, with every step demanding unwavering adherence to stringent quality standards. A single mistake can have devastating consequences, from product recalls to compromised patient safety. This is where “Root Cause Analysis (RCA)” takes center stage, becoming a vital tool for preventing future failures and ... Read More
SOP for CAPA (Corrective and Preventive Action) Handling Procedure
1.0 PURPOSE To lay down a procedure to be followed for administration of corrective and Preventive actions (CAPA) including tracking and reporting of the status of CAPA. 2.0 SCOPE 2.1 This procedure is applicable for all Corrective and Preventive Action that are recommended if any, but not limited to the ... Read More