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Turning Nasal Drops into Eye Drops - not a good Idea from the FDA's Point of View

In a Warning Letter, the FDA criticises eye drops from a Chinese manufacturer for not being manufactured under sterile conditions. The manufacturer argues that it made the eye drops under non-sterile conditions as nasal drops. Of course, the FDA did not accept this argumentation. Citing the FDA Aseptic Guide, the Warning Letter shows what the FDA considers to be the state of the art in aseptic manufacturing.

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Draft revision of ICH Q9 Quality Risk Management Guideline published

Since 2005 at the latest, the topic of quality risk management has dominated almost the entire GMP sector. At that time, the corresponding ICH Q9 guideline was published as "Step 4". Now the draft of a planned revision has been published. What could be in store?

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Cleaning Validation from the FDA's Point of View

The requirements for cleaning validation are not very clearly defined in the US GMP regulations 21 CFR 210/211. Even a Guide to Inspection on this topic dating back to the 1990s does not represent the FDA's current interpretation. Current Warning Letters on the subject of cleaning validation are helpful here.

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Results Survey Remote Factory Acceptance Tests (Remote FATs)

Due to the Covid-19 pandemic personal presence of pharmaceutical customers at the supplier site has generally been reduced or even become impossible - especially for FAT. So “remote-FATs” came up more and more in the last year and are still used. But how successful are such remote FATs? What are the problems showing up? This was something we wanted to find out from you, to get an overview - and therefore a survey was set up. Find out what the survey results were.

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Aide-Memoire from the PIC/S regarding the Inspection of Quality Risk Management

The PIC/S has developed a stand-alone Aide-Memoire (PI 038-2) on Quality Risk Management (QRM) for GMP inspectors. The aim of the document is to provide guidance to GMP inspectors on the inspection of QRM systems in the pursuit of harmonisation.

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Current FDA Requirements for Cleaning Validation

Since the GMP regulations are sometimes not very specific, concrete regulatory guidance on implementation is very helpful. In a current Warning Letter, the FDA specifies their requirements for cleaning validation. What does the FDA require?

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What is the FDA's Position on Concurrent Validation?

In the FDA Guidance for Industry on process validation, there is also a short section on concurrent validation. Concurrent validation should be used rarely, but may be possible if, for example, products are manufactured infrequently or medically necessary products are needed for short-term market supply. A recent Warning Letter underlines the guideline's statement that concurrent validation should be used rarely.

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ICH Q9 Risk Management to be Revised

Since 2005, the ICH Guideline Q9 has been the state of the art when it comes to quality risk management (QRM) in the GMP environment. Now it is to be revised. What is planned?

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The Influence of Process Changes on Process Validation

What influence can process changes have on process validation? A current FDA Warning Letter provides information on this.

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What do Authorities expect from Cleaning in the GMP Area?

Cleaning is an important process step in the field of pharmaceutical production. So what are the requirements for GMP-compliant cleaning from the perspective of the authorities? A current FDA Warning Letter provides information on this.

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