Swapnil Jain The Fundamental Problem: Density Mismatch Imagine a suppository mould is like a fixed-volume ice cube tray. When you pour water in, each “cube” holds exactly 1 gram. The mould is calibrated for a specific volume. Now, the suppository base (e.g., cocoa butter) has a known density. The manufacturer calibrates the mould so that when you use pure base, the resulting suppository … Read more
Fermentation Technology Notes PPT PDF Fermentation Technology: i. Anaerobic process that generates energy by the breakdown of organic compounds.ii. Any process that generates bacterial metabolites as end products: lactic acid, enzymes, ethanol, butanol, and acetone. Contents of Fermentation Technology Notes PPT PDF are Definition of Fermentation Technology Steps involved in Fermentation Principle of Fermentation How … Read more
Holders who intend to make post-approval changes to NDA and ANDA should follow in accordance with section 506A of the Federal Food, Drug, and Cosmetic Act. An applicant must provide Specific information to assess the effect of the change on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug.
Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval (for an existing licensed approved drug). The ANDA is submitted to the office of Generic drugs, US. After a review of the documents, USFDA gives approval as generic drugs.
After approval, an applicant may manufacture and market the generic drug product to the US market. A generic drug product is one that is similar to branded drug product in dosage form, strength, and route of administration, quality, performance characteristics, and intended use.
Statistical process control is a method of quality control which employs statistical methods to monitor and control a process. This helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste.
In-process controls are usually performed within the production area. The performance of such in-process controls should not have any negative effect on the quality of the product or another product. In-process inspection and testing should be performed by monitoring the process or by actual sample analysis at defined locations and times. The results should conform to established process parameters or acceptable tolerances.
All complaints and other information concerning potentially defective products must be kept and reviewed according to written procedures. In order to provide for all contingencies, a system shall be designed to recall, if necessary, promptly and effectively products known or suspected to be defective from the market.