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Showing posts from December, 2021

Get Proper Direction about the Custom Manufacturing

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A custom manufacturer is defined by its ability to design, engineer, and manufacture products that are specifically designed and engineered to meet specific needs. Custom-made products are typically made in small quantities on a made-to-order basis, as opposed to mass-produced items. Machines are still used in many processes, but Custom Manufacturing is by its nature much less automated and relies more on a small team of engineers and machinists to fabricate, inspect, test, and deliver the products. As custom products are made to order, quality assurance can also naturally be higher since what needs to be inspected, measured, and tested can vary from product to product, making metrology less standard. Due to the combination of these factors, production times will generally be longer and human involvement will be more intense. The result is generally higher costs for products that are custom-made, which are reflected in a higher price.  Specialization of the custom manufacturing or

Data Integrity in Good Manufacturing Practice

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Pharmaceutical quality systems rely on data integrity to ensure that medicines through GMP Packaging for the highest quality.  A robust data governance strategy will ensure that data is accurate, complete, and consistent, regardless of how it is generated, used, or retained. Assuring the quality and integrity of data Across all aspects of the quality system, a mature data governance system employs 'quality risk management. Continuous review, proportionate measures of risk reduction, and an understanding of residual risk throughout the organization are required. It is important to remember ALCOA regarding data integrity. Data should be attributed, legible (permanent), contemporaneous, original, and accurate.  Attributable: A record should clearly identify the person who completed it. An individual should be permitted to use aliases or abbreviated names only if they are consistently used. Tried-and-true aliases or IT system logins that cannot distinguish between different individu