As per Health Canada Guidance on GMP, GUI-0001, Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of a drug across the product lifecycle . In other words, the risk Management is defined as the identification, analysis, assessment, control, and avoidance, minimization, or elimination of unacceptable risks .
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Because of pandemic situation and the Russia-Ukraine war, Organizations have opportunities now to try new methodologies that will help them to be more efficient and successful in the long run. One thing among others you can do is to control your losses by implementing OEE tool.
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Design for Six Sigma (DFSS) is a structured approach to designing new products, processes and/or services to meet or exceed customer requirements and expectations. DFSS provides a more systematic way to manage the deliverable, resources, and trade-offs. It helps to deliver better products and services that your customers want and willing to pay for at Six Sigma Level.
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Biopharmaceuticals shall demonstrate at any time their compliance with Data Integrity (DI) requirements. We all know that data Integrity is not a new topic rather, it is an old concept made essential in today’s digital age.
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Validation Master Plan is an approved written plan of objectives and actions stating how and when a company will achieve compliance with the GMP requirements regarding validation. It is a document which defines the intentions and the methods that are related with validation of facilities, utilities, system, equipment, instruments, materials, analytical methods, It Systems, cleaning procedures and processes.
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