Upon meeting the requirements for the initiation of exhibit batches, the Quality Assurance (QA) department shall grant approval to proceed with the execution of the exhibit batch. The execution of exhibit batches will take place, and samples will be collected at various stages of manufacturing and packing, as outlined in the protocol. Any non-conformances identified … Read more
The process of developing new products varies significantly across different industries, and there is no universal or standardized procedure that can be applied to all sectors and organizations. Drawing from the comprehensive literature on the phases involved in the new product development process (Booz et al. (1969), Cooper (1979), Rosenthal (1992)), the new product development … Read more
Technical awareness of a new product involves understanding its key features, functionalities, design, technology stack, and potential applications. It also includes knowing how the product integrates with existing systems, its performance benchmarks, and any technical challenges or innovations involved To ensure the timely facilitation and planning of the product launch, it is essential to prepare … Read more
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
