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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Things You Need To Know About cGMP

CGMP or Current Good Manufacturing Practice regulations are enforced by the US Food and Drug Administration (FDA). They provide for systems which can assure proper monitoring, design and control of manufacturing processes and facilities. By adhering to CGMP regulations, you can assure the quality, strength and purity of any product manufactured by a company. You […]

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Guide to FDA Compliance Services in Pharmaceuticals

FDA compliance is an important aspect of maintaining pharmaceutical quality and standards. Pharma and biotech companies need to ensure they follow pharmaceutical cGMP (current Good Manufacturing Practice) guidelines to ensure that products don’t pose a risk to public health and safety. What is the FDA? The Food and Drug Administration (FDA) is a US federal […]

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What Pharma Companies Need to Know about FDA Regulations

Pharmaceutical and biopharmaceutical companies need to be aware of the FDA regulations that they are required to meet, in order to ensure quality compliance and safety for the products they manufacture. All too often, the smallest deviation from standards can result in entire batches being discarded or recalled after they hit the shelves. Not only […]

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