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
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
According to the solubility and permeability of drugs, the following Biopharmaceutics Classification System (BCS) is suggested in the literature (Amidon 1995) This classification serves as a foundation for establishing in vitro dissolution specifications and also aids in predicting the probability of achieving a successful in vivo-in vitro correlation (IVIVC). The solubility of a drug is … Read more
PROCESS VALIDATION Process validation is defined as the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes … Read more
WHAT IS QUALITY BY DESIGN? “You can’t test quality into drug products” has been heard for decades – so what’s new? ICH Q8 Pharmaceutical Development focuses on the content of the Module 3.2.P.2 of the Common Technical Document (CTD) and promotes the concept of QbD. It supports knowledge gained through the lifecycle of a product … Read more
