GMP News - Inspections/Audits

15.09.22

GDP Audit Check List for Air Freight Operations

When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for air freight operations.

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14.09.22

FDA Warning Letter: Lab Data Integrity disregarded

In July 2022, the U.S. FDA issued a Warning Letter to the U.S. American company "Jost Chemical Co." after having inspected its site in January 2022. The Warning Letter mentions the list of cGMP observations for Active Pharmaceutical Ingredients (APIs).

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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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31.08.22

FDA Form 483: Sampling Obviously Documented Incorrectly

The U.S. Food and Drug Administration (FDA) issued a Form 483 to India-based manufacturer Sun Pharmaceutical following an inspection of its Mohali facility in August 2022. Among other observations, it came out that employees responsible for collecting samples did not enter the buildings where the samples were documented to have been collected. In other cases, based on building access records, the employee was in a different building at the time the sample was documented to have been collected.

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25.08.22

GDP Audit Check List for Ocean Freight Operations

When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for ocean freight operations.

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25.08.22

Amazon Receives Warning Letter from FDA

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Amazon for selling unapproved drugs for mole and skin tag removal that have not been evaluated by the FDA for safety, effectiveness or quality. Amazon has 15 working days to respond and explain the specific steps that were taken to address the violations. Otherwise, legal action may result.

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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

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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17.08.22

FDA Warning Letter: No Stability Studies for Reworked Batches

In June 2022, the U.S. FDA issued a Warning Letter (WL) to the Spanish company "Bioiberica, SAU" after having inspected its site in January and February 2022.

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03.08.22

FDA expands Remote Regulatory Assessments

The FDA would like to use so-called Remote Regulatory Assessments (RRAs) not only during the COVID-19 pandemic, but also beyond it for the asessments of establishments and applications and has published a Draft Guidance for Industry on this.

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27.07.22

FDA Warning Letter: Missing Qualification of Contract Labs for Release

In June 2022, the U.S. FDA issued a Warning Letter tto the Dutch company "Fagron Group B.V." after having inspected their US American site "Fagron Inc." in November 2021.

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20.07.22

FDA Warning Letter: Benzene Contamination in Hand Sanitizer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a South Korean manufacturer of OTC drug products. During an FDA laboratory testing of a batch of hand sanitizer, the impurity benzene at unacceptable levels was found. After a review of records and other information provided by the manufacturer, the FDA came to the conclusion that the quality assurance within the facility is not functioning in accordance with CGMP requirements.

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06.07.22

Authorities test Hybrid Inspections

A pilot project will be launched under the auspices of ICMRA to conduct hybrid inspections at facilities of applicants.

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29.06.22

MHRA (UK) now also a full ICH Member

The United Kingdom (UK) becomes a full member of three international associations, including the International Council for Harmonisation ICH.

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21.06.22

New Guidance Documents for GCP Inspections

Following the previously published list of documents needed during GCP inspections, the EMA issued a set of updated documents on planning and conducting GCP inspections on its website. The annexes compile specific items that may be verified at the sponsor / CRO / investigator site and clinical laboratories.  

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