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End Product Testing versus Process Validation

End product testing versus validation? This is a question that is frequently discussed in the GMP environment. The argument is that if the specification of the end product fits, which is even included in the marketing authorisation, then the process must also fit. Otherwise, no specification-compliant product would be manufactured. For the FDA this is a good example that this is not "state of the art".

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FDA Requirements for Process Validation

Inspection results often help with the interpretation of regulatory requirements. The FDA Warning Letters are a very good source for that purpose. A recent Warning Letter criticises deficiencies in process validation. What did the FDA object to?

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FDA Warning Letter Defines Minimum Criteria for Process Validation

In addition to 21 CFR 210/211 and the related Guides to Inspection of as well as Guidelines/Guidances for Industry, Warning Letters are another way of interpreting the US cGMP regulations. Read more here about FDA's response to a pharmaceutical manufacturer's reference to not being aware of the need to perform process validation.

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"Bracketing" during Process Validation

"Bracketing" in process validation has become common practice. In the USA, bracketing has been practiced for some time, and the topic was included in the Annex 15 revision in 2015 (Chapter 5.4.). However, the bracketing concept must be well justified. This is shown by a recent Warning Letter issued by the US FDA.

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ICH Q9 Training Package for Revision 1 published

Since 2005, the ICH Q9 Guideline has been the state of the art when it comes to quality risk management. It was initially included in the EU GMP Guidelines as Annex 20 and was then incorporated into Part III. In addition, an ICH Q9 "briefing package" was developed and made available on the ICH website. New training material is now also available for Revision 1 of the ICH Q9 Guideline.

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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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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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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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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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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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