5 Tips to Help You Prepare for an FDA Inspection

Regulatory authorities such as the FDA have gotten more stringent with their acceptance criteria, especially when it comes to food and drug or medical device companies. You will not always be informed about an FDA inspection in advance, so you need to be fully prepared at all times if you want to avoid Form 483 […]

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The Need for Software Validation in the Pharmaceutical Industry

Software validation is essentially the process of ascertaining whether a software product meets the stated user requirements and goals. It is undertaken after the code verification process and is a crucial aspect of Beta testing. In the parlance of pharmaceutical industry, it is a subset of the validation process, which encompasses various procedures designed to […]

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The Principles of Process Validation – Stages and Types

Current Good Manufacturing Practices (cGMPs) require process validation for finished pharmaceuticals (21CFR 211) and medical devices (21CFR 820). However, until the 2011 guidance guidelines were set in place, there was a lot of uncertainty about how regulations for these sectors were to be implemented. Prior to this, most of the industry adopted the “three-batch practice”, […]

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Process Validation Studies – 4 Common Approaches You Should Consider

As a food manufacturer, under the FSMA (Food Safety Modernization Act) you now have to implement additional processes that ensure that production risks are mitigated, so you can deliver products that are safe and stable. Most manufacturers use a variety of thermal processes that kill pathogens and reduce spoilage, by targeting the microorganisms that reduce […]

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FDA Process Validation 101 – A Complete Guide

It is common knowledge that any company within the Food and Drug industry has to maintain certain sets of standard of their products. They cannot create benchmarks unique to themselves and compare the results with those individual standards. Food and Drug Administration state this would cause disparity in composition of similar products, compromise their quality […]

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