GMP News - Quality Assurance

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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07.09.22

Guidance for Industry on the Topic of Cross-Contamination

The topic cross-contamination is very important in the GMP environment. For example, Chapter 5 of the EU GMP Guide was adapted in this regard a few years ago. Annex 15 also paid more attention to the topic with the 2015 revision. However, the topic is also an issue in the USA.

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31.08.22

FDA also does not accept creative Arguments for Lack of Validation

In the GMP rules there are many undefined terms, such as regular, adequate, etc. Inspection reports that interpret these undefined legal terms sometimes help here. In this case it is about insufficient process validation. What happened?

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31.08.22

EU-GMP Adjustments in the next Years

The EMA has published a three-year plan. This plan of the GMDP Inspectors Working Group (IWG) also includes plans to revise the EU GMP guidelines.

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30.08.22

Medical Device Information available on EMA's Website

We have already reported about information regarding medical devices available on the EU Commission's website. Recently, a chapter on in vitro diagnostics (IVDs) was added. Also, the EMA website has a dedicated page for medical devices. What can be found there?

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30.08.22

FDA draws consequences for poor quality of hand disinfectants and UV Wands

In the follow-up to the pandemic situation, the FDA is still reviewing the manufacture and importation of hand sanitizers and identifying potentially critical hand sanitizers. This is shown by the warning letter issued to Guangzhou Orchard Aromatherapy & Skin Care Co.

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24.08.22

FDA Warning Letter: Testing, Stability Program and Quality Oversight

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an over-the-counter (OTC) drug product manufacturer in Los Angeles. Several GMP violations were identified in the area of laboratory testing, stability program, and quality oversight. In a previous inspection in 2018, similar observations were made. Therefore, the FDA considers the executive management oversight and control over the manufacture of drug products as inadequate.

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24.08.22

China GMP: New Annex 13 for IMPs

In May, the Chinese National Medical Products Administration (NMPA) published their new Annex 13 "GMP for Investigational Medicinal Products (IMPs)", which was incorporated into the Chinese GMP guidelines on July 01, 2022.

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24.08.22

Refusal to Permit Inspection - What are the Consequences?

Inspections are a regulatory requirement in the GMP environment. This also applies to the USA. But what happens if a manufacturer simply refuses to permit a GMP inspection?

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24.08.22

FDA publishes ICH Q9 Draft Document

Since the end of last year, the ICH Q9 document on quality risk management has been in stage 2 of the ICH process for publishing ICH documents as a draft revision 1. Now, the draft document has also been published by the FDA on its website and is available for comments.  

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17.08.22

Data Integrity Problems as Main Topic of an FDA Warning Letter

Data integrity is still one of the major topics in FDA inspections. Missing controls to ensure the integrity of electronic data as well as inadequate access controls were some of the reasons why a Warning Letter to American company Vi-Jon was issued.

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17.08.22

Training and the FDA

The US American CGMP Rules 21 CFR 211 also contain requirements concerning training (21 CFR 211.25). An actual warning letter shows the current interpretation of this requirement by the FDA. How does the FDA interpret the chapter "Training" today?

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