GMP News - Inspections/Audits

08.02.23

Swissmedic specifies Requirements for EU-GMP Certificates

Swissmedic specifies its requirements for the validity of EU-GMP certificates in Switzerland.

08.02.23

FDA Warning Letter: Acetaldehyde and Acetal Impurities in Hand Sanitizers

The U.S. Food and Drug Administration (FDA) has published two Warning Letters to manufactures of hand sanitizer drug products. In both cases, acetaldehyde and acetal impurities at unacceptable levels were found in several lots. The agency is concerned, because acetaldehyde is considered to be genotoxic, and potentially carcinogenic.

08.02.23

European Inspectors criticise Cross Contamination

In the EudraGMDP database, results of European inspectors are published in so-called Non-Compliance Reports. In the period October-November 2022, there were two reports in the area of GMP, both of which were issued due to cross contamination.

08.02.23

European Commission: Canada Part of the "White List" ?

Furthermore, the "Falsified Medicine Directive (2011/62/EU)" requires a "Written Confirmation" for the import of active pharmaceutical ingredients (APIs) from third countries. The APIs imported from countries on the so-called "White List" are an exception to this. In future, Canada will also be listed on this "White List".

26.01.23

FDA Warning Letter due to Inadequate Storage Conditions and Repacking/Relabeling Operations

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a drug repackaging and relabeling facility located in Pennsylvania. The document summarizes significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). It also addresses Good Distribution Practice (GDP) aspects.

26.01.23

GDP in the US: FDA warns Company for Violation of Drug Supply Chain Security Act

The U.S. Food and Drug Administration (FDA) has published a so-called untitled letter to a US company. The FDA states that the firm violated the Drug Supply Chain Security Act (DSCSA). Specifically, the letter concerns a former subsidiary of the company that was a licensed pharmacy and wholesale drug distributor.

18.01.23

FDA signs MRA with Switzerland

The FDA has signed a Mutual Recognition Agreement on GMP inspections with Switzerland. It applies to both human and veterinary medicinal products.

11.01.23

Cross Contamination in Steam Steriliser at US Sterile Manufacturer

In October, the US FDA issued a Warning Letter to a US sterile manufacturer due to numerous GMP violations. The inspection, which had already taken place from March to April 2022, had revealed numerous deficiencies. The main reasons for the Warning Letter were cross contamination and microbiological contamination of products.

14.12.22

FDA Warning Letter to Glenmark due to Laboratory Issues

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Glenmark Pharmaceuticals Limited. During an inspection at the site in Goa, India, several GMP violations were found. The company failed to thoroughly investigate OOS results. In addition, the FDA considers the chromatographic data integration procedure as inadequate.

07.12.22

FDA Warning Letter: Too low Ethanol Content in Hand Sanitizer Products

There has been a recent accumulation of Warning Letters from the U.S. Food and Drug Administration (FDA) to manufactures of hand sanitizer products. At the end of November, a further letter was published. In this case, FDA laboratory analyses showed that the ethanol content of several batches was too low. In addition, the FDA has also found numerous GMP violations. There was already a lack of the necessary basic SOPs.

07.12.22

In 2022 again Numerous FDA 483s due to Deficiencies in the Stability Program

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for the fiscal year 2022. Deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms.

23.11.22

Broader Acceptance of GMP Inspection Reports from PIC/S Countries

Some authorities within the PIC/S want to mutually recognise GMP inspection reports in order to avoid duplication of work. There is now a corresponding statement on this.

23.11.22

FDA Warning Letter to Drug Manufacturer in Puerto Rico

Just recently, we reported on a Warning Letter to an American manufacturer of hand sanitizer drug products. Now another Warning Letter has been published by the U.S. Food and Drug Administration (FDA), also addressed to such products. In this case, it is about a drug manufacturer located in Puerto Rico. In addition to formal GMP violations and inadequate analytical testing, the FDA also criticizes the overall condition of the production facility.

16.11.22

MHRA resumes international Inspections

In a blog post, the UK MHRA comments on the resumption of international GMP inspections and the validity of expired GMP certificates.

16.11.22

FDA Warning Letters of the Fiscal Year 2022: the "Top Ten" GMP Deficiencies

The analysis of the Warning Letters sent out in fiscal year 2022 offers a revealing overview of what FDA inspectors find when they visit the production facilities of medicinal product manufacturers. Read more about the "Top Ten" GMP violations.

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21 March 2023

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GMP News - Inspections/Audits

Swissmedic specifies Requirements for EU-GMP Certificates

FDA Warning Letter: Acetaldehyde and Acetal Impurities in Hand Sanitizers

European Inspectors criticise Cross Contamination

European Commission: Canada Part of the "White List" ?

FDA Warning Letter due to Inadequate Storage Conditions and Repacking/Relabeling Operations

GDP in the US: FDA warns Company for Violation of Drug Supply Chain Security Act

FDA signs MRA with Switzerland

Cross Contamination in Steam Steriliser at US Sterile Manufacturer

FDA Warning Letter to Glenmark due to Laboratory Issues

FDA Warning Letter: Too low Ethanol Content in Hand Sanitizer Products

In 2022 again Numerous FDA 483s due to Deficiencies in the Stability Program

Broader Acceptance of GMP Inspection Reports from PIC/S Countries

FDA Warning Letter to Drug Manufacturer in Puerto Rico

MHRA resumes international Inspections

FDA Warning Letters of the Fiscal Year 2022: the "Top Ten" GMP Deficiencies

Recommended Event

Full-day pre-course session Audit Trail Review Book together with the course "Data Integrity - Requirements for a GMP-compliant Data Life Cycle " and save up to € 590,-

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