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Weight and quality measurement in pharmaceutical industry

Information sources:本站 | Release date: 2020-01-07 | Browse volume:222
Summary:The manufacturing process of drugs is associated with a smaller or greater risk of error. In this case, the risk is to point to the marketing of drugs that are harmful to patients. In order to avoid this situation, special attention has been paid to t…
The manufacturing process of drugs is associated with a smaller or greater risk of error. In this case, the risk is to point to the marketing of drugs that are harmful to patients. In order to avoid this situation, special attention has been paid to the quality control process and its promotion for many years, but it does not lead to error elimination. ^Recently, manufacturers have chosen the concept of high-quality drugs obtained through their design "quality by design", rather than the control process of ready-made products. When describing quality, it should not be evaluated through product testing, but should be "implemented into the product" or guaranteed by the project design.

In most of the processes used for formulation elaboration, mass measurement should be carried out, and the weighing mass has a significant impact on the quality of the final result. As a result, pharmaceutical companies define acceptance criteria, and USP provides recommendations for the weighing process of ingredient weighing instruments, which are not included in the European Pharmacopoeia, which is why they do not use their own balance estimation criteria from companies that are required by the US.

Pharmacopoeia, pharmacy code - an official list of drugs in a specific country or market and prepared by hand from certain drugs (prescription drugs) in the same regulated inventory of fortified drugs. In Poland, the official pharmacopoeia is the Polish Pharmacopoeia published by the registered office of drugs, medical products and biological killers. Currently, the Polish Pharmacopoeia VIII is valid and was edited in 2008, i.e. the European Pharmacopoeia 6.0 was translated into Polish.
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