GMP News - Quality Assurance

02.11.22

FDA Warning Letter for Chinese OTC Hand Sanitizer Drug Products Manufacturer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer. The FDA blames the company in question for a whole series of GMP violations, including to identity testing, cleaning and maintenance of equipment, microbial testing and QU oversight.

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02.11.22

Cross Contamination Risk: Production stopped

In April, the US FDA inspected a manufacturer of OTC products in Mexico. Due to the deficiencies found, in particular the unacceptable risk of contamination, the production was stopped.

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02.11.22

Sterile Product Manufacturing Process: Warning Letter to Texas Longhorn

After incomplete processing of defects listed in a 483, the Austin-based compounding manufacturer Texas Longhorn received a Warning Letter from the FDA.

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19.10.22

EDQM issues monthly CEP Report

Also in September 2022, the EDQM has prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" (Certificate of Suitability of Monographs of the European Pharmacopoeia) and has now published it in the EDQM website newsroom.

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19.10.22

How to get free Access to FDA 483s

FDA's Office of Regulatory Affairs (ORA) publishes electronic copies of various inspection and related records on their websites.

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19.10.22

FDA Warning Letter: Product Mix-Ups and Insanitary Conditions at US Repackager

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Missouri. The company failed to adequately investigate the presence of foreign tablets in the drug products. Furthermore, during an FDA inspection, one operator was observed to pick individual tablets up off of the floor and place them directly into the feed hopper.

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19.10.22

How to react to Deficiencies after an FDA Inspection?

GMP deficiencies are often identified during FDA inspections. Responding to an FDA deficiency report is important, otherwise a Warning Letter may be issued. But how should one respond?

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12.10.22

Manufacturing medicinal and non-pharmaceutical Products on the same Equipment - is that possible?

Is it possible to manufacture medicinal and non-pharmaceutical products on the same equipment? The FDA objects to this manufacturing practice.

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04.10.22

New Article on CDRH Learn

You could already read in the past about the FDA CDRH's website for medical devices. It provides you with the possibility to get familiar quickly with the topic "medical devices" or to stay up to date. What is new?

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04.10.22

Risk Management Plans to Mitigate Drug Shortages also affect Medical Devices

In a draft document, the FDA has presented risk management plans to mitigate drug shortages. What are those plans?

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28.09.22

Revised Ph. Eur. Chapter on Foreign Matter

The final version of Ph. Eur. 2.8.2 Foreign Matter in herbal drugs has been published in Ph. Eur. 11.1. The revised chapter clarifies that the quantitative limits for foreign matter only apply to foreign organs and foreign elements; other foreign elements should, as far as possible, be absent.

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21.09.22

FDA Warning Letter: Potentially Carcinogenic Contaminants in Hand Sanitizers

The U.S. Food and Drug Administration (FDA) has again found genotoxic and potentially carcinogenic impurities in hand sanitizers. In this case, it is about an American manufacturer in whose products benzene, acetaldehyde and acetal impurities were detected at unacceptable levels.

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20.09.22

Labeling Requirements for IMPs Amended

The European Commission finally adopted the revised Annex VI to the CTR as regards labelling requirements for IMPs. The amendment eliminates the obligation to include an expiry date on the primary packaging of IMPs in specific circumstances.

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14.09.22

FDA Requirements for the "Worst Case" Product during Cleaning Validation

Bracketing approaches are certainly allowed in the context of cleaning validation. First, for the products themselves, so that a "worst case" substance can be used for validation, second, for devices of the same design, the effort can be reduced by bracketing. In this way, a device can be selected. So how to define these "worst cases"? Read more here about FDA's view on this.

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14.09.22

Pharmaceutical Industry: FDA Data on the Level of Quality

The FDA has published a report on the state of drug quality - and the results are mixed. However, if one takes a closer look, the reasons can be quickly identified.

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