Typically, it is anticipated that process validation should be finalized before the distribution of a finished product intended for sale (prospective validation). In cases where this is not feasible, it may be essential to validate processes during regular production (concurrent validation). Additionally, processes that have been operational for a considerable duration without any major modifications … Read more
The extent and intricacy of a qualification exercise are often connected to the complexity of the equipment in question and the essential role that equipment plays in ensuring the quality of the final product. Installation and operational qualification exercises guarantee, through suitable performance tests and accompanying documentation, that the equipment, along with its ancillary systems … Read more
A validation master plan is a document that encapsulates the company’s overarching philosophy, objectives, and strategies for determining performance adequacy. It is essential that the validation master plan receives approval from management. Validation generally necessitates thorough preparation and careful planning of the different stages involved in the process. Furthermore, all tasks should be executed in … Read more
The packaging of pharmaceutical products is a comprehensive, extensive, and intricate endeavor. It significantly differs from food packaging and presents similar challenges. This process necessitates the utilization of substantial scientific and engineering knowledge to produce a product suitable for the global market. The practice is centered around information and expertise drawn from various scientific fields, … Read more
The Orange Book lists the following as Patents: The active substances or compounds are claimed in patents. Patents on drug products, including formulation-composition patents. Utilize patents for a certain authorized use or indication of the product. The Bolar amendment to the Drug Price Competition and Patent Term Restoration Act permits a pharmaceutical manufacturer (sponsor) to … Read more
A pharmacopoeia constitutes a legally enforceable compilation of standards and quality criteria for medications utilized within a specific country or region. The term “Pharmacopoeia” was first used as a specific title in a publication from Basel, Switzerland, in 1561 by Dr. A. Foes, although it did not gain widespread usage until the early 17th century. … Read more
A specification is characterized as a compilation of tests, references to analytical methods, and relevant acceptance criteria, which consist of numerical limits, ranges, or other standards for the tests outlined. It delineates the criteria that a drug substance or drug product must meet to be deemed acceptable for its intended application. The term “conformance to … Read more
Tablet compression machines are designed with consideration for the types of dies and punches that will be utilized on them. The arrangement of dies and punches on a compression machine is referred to as tooling, which is primarily classified into B and D categories. The B tooling dies and punches can further be specified as … Read more
PAN COATING OVERVIEW Functions of the parts Inlet & Outlet System of a Pan Coater Inlet of the Pan Outlet of the Pan FLUID BED COATING (WURSTER COATING) FBC is a technique for coating pellets, spheres, particles or granules using a spray of solution inside a column. The spray nozzle is installed in the base … Read more
Most coating processes typically utilize one of the general coating systems, such as the standard coating pan, perforated coating pan, and fluidized bed coater. A notable advancement in the efficacy of standard coating pan systems has been marked by the introduction of the Pelligrini pan, immersion sword, and immersion tube systems, where coating solutions are … Read more
