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Recent GMP defects in process validation

What are the authorities' requirements regarding process validation? Regulatory GMP inspection reports are useful in answering that question. The "Freedom of Information Act" obliges the US FDA to publish all inspection results. The FDA does that particularly when it comes to warning letters.

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Critical Process Parameters and Process Validation

Regulations require that the critical process variables should be included in validation. This has been recently confirmed again by the FDA in a Warning Letter.

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Process Validation - FDA criticises Missing Lifecycle

In a Warning Letter recently published, the FDA addressed deficiencies regarding process validation. What did the FDA discover?

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Cleaning Validation under the View of the FDA

With the publication EMA's guideline on Shared and Dedicated Facilities and the revision of Annex 15, the topic of cleaning validation has gained new attention. The PDE concept is now the determining factor. But what about the FDA?

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Monographs on radiopharmaceutical preparations - Revised Guideline

At the beginning of the year, the EDQM published a revised version of its guidelines for the preparation of monographs on radiopharmaceutical preparations. It now includes a new section on method validation.

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Cleaning Validation of Medical Devices: What should it look like? An ASTM Guide provides Answers

There are regulations for cleaning validation in the pharmaceutical sector and in the manufacture of active ingredients. But what about the cleaning validation of medical devices?

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Cleaning Validation: What can a Quality Risk Management Approach Look Like?

With the implementation of the ICH Q9 document, risk management has become mandatory in virtually all GMP areas. This also applies to cleaning validation. But what can such a quality risk management approach look like for cleaning validation? The American Society of Testing and Material (ASTM) has recently issued a guideline on a Science-Based and Risk-Based Cleaning Processes Development and Validation. What does the Guide suggest?

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Cross Contamination: One of FDA's Current Issues

In a current Warning Letter from November 2018, the FDA criticised insufficient cleaning validation and verification at a pharmaceutical manufacturer. They referred to 21 CFR 211.67 (a). What was the reason for this?

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Warning Letter for Korean Manufacturer due to Poor Sterile Practices

As a result of repeated deviations in the area of aseptic manufacturing, a Korean manufacturer has received a Warning Letter from the FDA.

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British Regulatory Authority MHRA criticises Cross Contamination Issue

The publication of EMA's "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" and the related Q&A documents have given the topic cross contamination a greater importance.

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