US FDA: Draft on Data Integrity for BE/BA Studies published
At the beginning of April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website and is now available for comment for 60 days. The document is intended to assist applicants and marketing authorisation holders in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies.
Cloud Computing: Workaround for non-compliant PaaS
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 19: A non-(GXP-)qualified PAAS could change the versions of some of its generic microservices used by the application to be deployed as a GXP SAAS. Changing the versions of such generic microservices could be beyond the control of the SAAS provider. What would be required to make this scenario GXP-compliant?
Cloud Computing: Validation performed by a CSP on its own - what is the Value?
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 18: What is the value of a "validation" performed by a CSP on its own for the services it provides?
Cloud Computing: Can an automated Deployment Chain replace an IQ?
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 17: Can an automated deployment chain replace an IQ? If so, what information must the deployment chain provide?
Cloud Computing: Consequences of different service models for Qualification / Validation
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 16: What are the consequences of the different service models (IaaS / PaaS / SaaS / XaaS) for supplier management and the related qualification / validation?
Cloud Computing: Validation of SaaS; who is accountable?
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 15: Special considerations for validation of SaaS; who is accountable?
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?
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?
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?
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?
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?
Can Productivity Applications be Used in Clinical Trials?
EMA's GCP Inspectors Working Group added a new Question & Answer relating to Productivity Applications in the section "GCP matters" of the Good Clinical Practice (GCP) Q&As. What are the Expectations for Productivity Applications used in Clinical Trials?
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?
FDA Paper on Artificial Intelligence in the Manufacture of Medicines
The US FDA recently published a discussion paper addressing artificial intelligence in the manufacturing of medicinal products. The FDA is considering the extent to which its risk-based regulation is applicable to AI technologies in the manufacturing of medicinal products.
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?