GMP compliance in pharmaceutical manufacturing requires that any process, person, environment, or equipment with direct impact on the quality and safety of the product being produced must operate within specified limits. These specified limits should be under the direct control of the manufacturing team, with countermeasures available in the event of a problem. In addition, any other part of the production or storage processes that have an indirect impact must also be assessed for possible risk impact. Deeper Insights Power is Not the Same as Efficiency Humidity may not seem like an obvious cause of problems, or something that could even result in production being non-compliant, but this can and does occur. Just because one does not see an issue doesn’t mean there isn’t a problem. Many phenomena are influenced by the relative humidity level, and they can cause production processes to be less efficient, less predictable, and more prone to producing products that don’t meet specification. Some common issues that can arise from poor humidity control are: Click Here For Complete Article Text
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