GMP News - Validation

25.10.23

What are the FDA Requirements for Equipment Qualifications?

What are the FDA requirements for equipment qualifications? This is a question that requires a more detailed look into the regulations. However, a current Warning Letter offers a more simple way for information.

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27.09.23

CAPAs after Validation Deficiencies

The FDA Warning Letters are a very good source to get to know how the FDA reacts to GMP deficiencies. In a current Warning Letter, the FDA comments on deficiencies in the context of process validation, among other things. What "CAPA" measures did it call for?

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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?

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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?

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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?

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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?

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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?

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23.08.23

Are Placebo Batches Allowed in Cleaning Validation?

In our News dated 16 August 2023, we referred to a Warning Letter issued to an Indian API manufacturer. Among other things, the FDA criticized the company for residues on internal surfaces of equipment parts. The deviations were found during an FDA inspection conducted in November 2022. In late January/early February 2023, the FDA was back at another site of this company for inspection. What did the FDA find this time?

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16.08.23

FDA Warning Letter: Inadequate Investigation of Humidity Excursions

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. During an inspection at an Indian company, the FDA investigators observed several GMP violations concerning inadequate investigation of humidity excursions, data integrity deficiencies, and inadequate testing of component lots used to manufacture the OTC drug products.

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16.08.23

Even Non-Reactive Residues Are Considered Cross-Contamination and Require Validation

In a recent Warning Letter, the FDA presented its view on the topic of cleaning validation. What is it about?

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09.08.23

Identity Testing of Glycerin in Focus of an FDA Warning Letter

At the beginning of August, the U.S. Food and Drug Administration (FDA) has published a new Warning Letter. As in several cases in recent months, it is again about a US manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. In addition, a number of other CGMP violations are documented.

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24.05.23

Consequences of manufacturing non-pharmaceutical Products on pharmaceutical Equipment

In October 2022 you could already find out in a news that the FDA does not accept the manufacture of medicinal products on equipment that is also used to manufacture non-pharmaceutical products. But what are the consequences if the FDA does discover such manufacturing?

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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.

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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?

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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?

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