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Building Consistent Processes with Quality by Design
Building Consistent Processes with Quality by Design
1 Oct 2015Weighing processes are important elements in many pharmaceutical manufacturing processes, such as batching, formulating or filling. Depending on the application, different aspects of weighing can play an important role in maintaining an accurate and reliable process and ensuring consistent product quality. This white paper takes a look at the impact of these weighing processes on final product quality and explains what needs to be considered in a Quality by Design (QbD) based manufacturing process.
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Balances and Moisture AnalyzersBalances & Moisture Analyzers / weighing scales measure static or dynamic loads. Features to consider when choosing an analytical balance include accuracy, capacity and resolution. Additional features and specialized balances include enclosures for weighing powder, microbalances for measuring small quantities, portable balances, moisture analyzers, top loading balances and internal calibration for measurements over time or with varied temperature.Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Drug DosageDosage is the size or frequency of the administration of a drug. Determination of the dosage of a drug is critical in pharmaceutical development to ensure the optimum balance between efficacy and toxicity.Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. ManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.