GMP: Are there "planned" Deviations? 2021-05-20

A discussion we have again and again inseminars is the question of planned deviations. To make it short: in GMP, nothing should be declared as a de ...

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ALCOA+ - what does it mean? 2021-05-20

Since data integrity has become a "hot topic" in the pharmaceutical industry, ALCOA+ has been cited as the ultimate reference. Nevertheless, the me ...

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FDA Plans for new (GMP) Guidance in 2021 - CDER provides Information 2021-03-23

What are the FDA's plans regarding new guidances for the calendar year 2021? An answer to this question is provided by the Center for Drug Evalu ...

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OOS, Complaints also need CAPA Plans 2020-11-04

Some companies still might thing that only deviations lead to corrective and preventive actions ( CAPA ). But that is not true. A recent  Warnin ...

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Remote Release and Remote Audits: New Answers from the EU 2020-04-27

The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on a series of measures to mitigat ...

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Warning Letter: Lack of Repairs at US-American Manufacturer 2020-04-16

A US-American pharmaceutical manufacturer of  OTC solutions  and suppositories has received a Warning Letter from the US-American FDA due t ...

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