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
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
Following are the critical parameters in Coating operation Gun Geometry and Calibration Gun geometry and Calibration refers to the position of spray guns which includes ‘Gun Calibration’, ‘Gun to bed distance’, ‘Gun to gun distance’, ‘Gun to side of pan’, ‘choked guns’ and ‘anti bearing technology’. Gun to bed distance: Gun to Bed Height: Gun … 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
