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Cloud Computing: Reasons for choosing the particular Cloud Model?

Financial and organizational advantages also 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 3: What are the reasons for choosing the particular cloud model (private cloud, community cloud, public cloud)?

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FDA signs MRA with Switzerland

The FDA has signed a Mutual Recognition Agreement on GMP inspections with Switzerland. It applies to both human and veterinary medicinal products.

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Cloud Computing: Cloud Models in the GxP environment

Financial and organizational advantages also 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 2: What cloud models are there and where do they have applications in the GxP environment?

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FDA Warning Letter: Data Integrity and Good Documentation Practice Failures

In November 2022, the U.S. FDA issued a Warning Letter to the U.S. American company Kari Gran Inc. after having inspected its site in July 2022. The Warning Letter mentions the list of cGMP observations for finished products.

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Revision of the EU GMP Guide Annex 11 "Computerised Systems" - Presentation of Concept Paper

The current EU GMP Annex 11 "Computerised Systems" was published in 2011. Due to new technological and regulatory developments, a forthcoming revision of Annex 11 has been discussed for some time. On 16 November 2022, the EMA published a concept paper for public comment. Which points are to be revised?

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MHRA resumes international Inspections

In a blog post, the UK MHRA comments on the resumption of international GMP inspections and the validity of expired GMP certificates.

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Cloud Computing: What is the meaning of Iaas / PaaS / SaaS / XaaS?

Financial and organizational advantages also 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 1: What is the meaning of IaaS / PaaS / SaaS / XaaS?

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How to get free Access to FDA 483s

FDA's Office of Regulatory Affairs (ORA) publishes electronic copies of various inspection and related records on their websites.

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How to react to Deficiencies after an FDA Inspection?

GMP deficiencies are often identified during FDA inspections. Responding to an FDA deficiency report is important, otherwise a Warning Letter may be issued. But how should one respond?

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Data Integrity Problems as Main Topic of an FDA Warning Letter

Data integrity is still one of the major topics in FDA inspections. Missing controls to ensure the integrity of electronic data as well as inadequate access controls were some of the reasons why a Warning Letter to American company Vi-Jon was issued.

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