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GMP News

The EU Qualified Person - What's it all about?

If you are a non-EU based company exporting drug products into the EU, it is essential to understand the role of a QP. It's also helpful to understand all other EU-GMP requirements to be better prepared for inspections.

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Cloud Computing: Content of a SLA/Contract with a XaaS Provider

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 20: What should be the content of a SLA / contract with a XaaS provider?

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USP-NF Stimuli Article on Stability of Compounded Preparations

The stability of a compounded preparation has several factors that must be evaluated by compounders utilizing or developing stability studies to determine the Beyond-Use Dates (BUDs). In this context, a Stimuli article entitled "Stability Reference Document for Pharmaceutical Compounding" was published in the Pharmacopeial Forum, PF 50(6).

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