GMP News - Computer Validation

27.09.23

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?

26.09.23

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?

20.09.23

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?

24.08.23

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?

23.08.23

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?

24.05.23

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.

17.05.23

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?

10.05.23

Cloud Computing: Audit / Remote audit of a Cloud Service 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 11: How many days must be planned for the audit of a CSP? Is it also possible to carry out a remote audit?

03.05.23

Cloud Computing: Which Persons should participate in the Audit of a CSP and which Topics should be addressed?

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 10: Which persons (functions) should participate in the audit of a CSP and which topics should (must) be addressed?

02.05.23

FDA's Q&A Paper on Electronic Systems & Electronic Data in Clinical Trials

The FDA issued a new version of the draft guidance on electronic systems in clinical Investigations. The document provides additional recommendations on the risk-based approach to validation of electronic systems.

26.04.23

Cloud Computing: Multi-tenant provisions of SAAS and Change Control

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 9: The multi-tenant provision of SAAS is accompanied by a source code basis for all customers. This implies that all customers must have the same software version irrespective of whether or not a customer accepts a certain change. Is this compatible with GxP?

19.04.23

Cloud Computing: Which contents must be covered by the service provider's change control?

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 8: Which contents must be covered by the service provider's change control and in which way must the contract giver be integrated into this system?

19.04.23

APIC: FAQs on Data Integrity

In April 2023, the Data Integrity Task Force of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. This document providees numerous questions and answers on the topic data integrity that were submitted to the Task Force by the pharmaceutical industry.

11.04.23

Final GCP Guideline on Computerized Systems and Data Integrity

The final EMA Guideline on computerised systems and data integrity in clinical trials has now been published. Amongst others, the new document requires procedures to be in place for risk-based trial specific Audit Trail Reviews. In addition, a new expression is defined: ALCOA++.

29.03.23

Cloud Computing: QMS of the Cloud Service Provider (CSP)

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 7: Can we assume that if there is an appropriate QMS implemented and if the CSP acts in compliance with this QMS (as a result of an audit), the service provided functions in accordance with the specification and the operational controls are carried as described in the CSP's internal procedures?

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