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Antoine N

Antoine N

Environmental Monitoring Best Practices: Maintain Compliance and Monitor Critical Conditions

Environmental monitoring refers to the process of collecting environmental data over time and monitoring for any changes that could be detrimental to the manufacturing or distribution of a product.

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An Essential Guide to GxP (Good Practices) for Heavily Regulated Industries

In many cases, individual consumers cannot verify the quality of products that can significantly affect their health and safety. Instead, they rely on manufacturers and distributors to follow a strict set of practices to consistently manufacture, store, and distribute high quality products.

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Thermal Mapping from A-Z

When it comes to producing and storing temperature-sensitive products, sometimes the long list of terms and information involved in mapping can get a little confusing. Below is a list of abbreviations and key terms to help make digesting your mapping report and validation easier.

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USP <795> and <797> Revisions: What Compounders Should Know

The United States Pharmacopeial Convention, or USP, is a nonprofit science-driven organization that establishes standards for medicines. These standards are developed with independent experts and are primarily published in a compendium of General Chapters. While USP deals with quality and...

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Medieval to Modern: Refrigeration's Impact on Vaccine Degradation

The magic of medicine has blossomed over time to become what it is today, but modern medicine came into existence long before now. The 19th and 20th century were full of invention and discovery to help us get from where we were, when severe illnesses were often believed to be supernatural in...

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Our View: Data Integrity and Compliance With CGMP

With the ever increasing concern on data integrity and FDAs uptick of warning letters concerning the subject matter, FDA has released a draft guidance for those in the industry.

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