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Cloud Computing: Assessment of Cloud Suppliers from an authority's point of view

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 14: What should the assessment of "cloud suppliers" include from an authority's point of view?

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Cloud Computing: Relevance of SOC / SOC2 reports

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 13: A cloud service providers refers to SOC reports when assessed, especially to the SOC2 report. Would this report be sufficient as concerns the requirements of the assessment and could it be used?

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GMP and critical Computerised Systems

During GMP inspections, inspectors should first look at critical (computerised) systems. Neither the EU GMP Guide nor Annex 11 or 15 give clear guidance on how to identify such critical systems. How can a system be established within the company to identify the criticality of computerised systems?

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New EMA Reflection Paper on the use of Artificial Intelligence

On 19 July 2023, the EMA (European Medicines Agency) published a Reflection Paper on the use of Artificial Intelligence (AI) in the medicinal product  lifecycle. This document is open for comments until 31. December 2023. What is the content of the document?

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GMP and Critical Data

In the GMP environment one often talks about critical data. The term "critical data" only appears in a few places in the EU GMP Guidelines and their annexes and is also not clearly defined. How does one deal with this?

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The possible Impact of Artificial Intelligence on the Role of the Qualified Person

Artificial intelligence (AI) is revolutionising industry, and the pharmaceutical sector is no exception. One might think AI reaches its limits when it comes to GMP. But there are promising possibilities.

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New Warning Letter includes Deviations to Computerized Systems

On 1 August 2023, the FDA issued a Warning Letter to the Indian company Intas Pharmaceuticals Limited, as a result of which an Import Alert was issued. What points were criticised with regard to computerised systems?

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EMA: New Update of the Q&A Documents on Centralised Procedures

Once again, the Questions & Answers documents with regard to centralised marketing authorisation procedures have been revised and published on the European Medicines Agency (EMA) website in June 2023. The Q&As, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application.

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Packaging of Solid Dosage Forms: Warning Letter in the USA

Due to numerous GMP deficiencies, a US company in the field of solid dosage form packaging received a Warning Letter from the FDA. The inspection had already taken place in November 2022. Since the FDA found the company's response to the Form 483 as insufficient, the Warning Letter now followed.

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Cloud Computing: Is a check list for the assessment of a Cloud Service Provider sufficient?

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 12: Will it be sufficient to send a check list for the assessment of the CSP - for instance Amazon and Microsoft?

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