GMP News - Inspections/Audits

24.06.20

FDA Warning Letter for Canadian Drugmaker - HPLC and Data Integrity in the Focus

The U.S. Food and Drug Administration (FDA) has recently published a Warning Letter to a Canadian over-the-counter (OTC) drug producer. During an inspection, the FDA found significant violations of current good manufacturing practice (CGMP), including data integrity issues related to HPLC analysis.

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17.06.20

MRA: 25% less FDA Inspection in the EU

In 2019 the US Food & Drug Administration FDA was able to reduce 25% of routine surveillance inspections in the European Union, as reported by the authority.

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17.06.20

Serious Deficiencies at US Sterile Manufacturer

The FDA has recently published a Warning Letter following an inspection conducted at a US-American manufacturer of ophthalmic sterile preparations, which revealed numerous serious deficiencies. These include environmental monitoring, lab data integrity, gowning procedures, media fill and maintenance/cleaning of production equipment.

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03.06.20

FDA Warning Letter to US Drug Maker

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a US-based drug maker for significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, including the failure to investigate out-of-specification (OOS) test results and to follow proper documentation practices.

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27.05.20

Is Cannabis an API, a Herbal Drug or a Herbal Medicinal Product?

The classification defines, among other points, which kind of GMP certification is needed for export / import of Cannabis Flower to the EU and Germany.

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26.05.20

COVID-19: How to manage temporary GDP Process Changes and Risks

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a post on temporary changes in Good Distribution Practice (GDP) in the MHRA Inspectorate Blog.

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13.05.20

More and more Inspectorates are performing Remote Inspections

TGA has published a media release stating that they have started to undertake "remote and/or hybrid GMP domestic inspections" in place of on-site inspections.

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29.04.20

Evidenced Cross-Contamination at Indian Manufacturer results in Warning Letter

The FDA has recently issued a Warning Letter to a large Indian pharmaceutical manufacturer following an inspection that revealed poor cleaning and later detected cross-contamination in manufactured tablets. Further GMP violations were detected like leaking HEPA filters and inadequate smoke studies in the sterile area.

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29.04.20

FDA Warning Letter to EU Company

Despite the MRA, FDA is still coming to the EU to inspect. Now a company from Bulgaria received a Warning Letter and was placed on Import Alert.

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22.04.20

Remote Release and Remote Audits: New Answers from the EU

EMA, EC and HMA have created a Q&A document on regulatory expectations during the covid-19 pandemic. New questions and answers are dealing with remote audits and remote release.

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22.04.20

FDA Warning Letter: No Compendial Methods established? Develop appropriate Testing Procedures by yourself!

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Romania-based manufacturer of an unapproved new drug due to, among others, releasing drug products without conducting identity and strength testing.

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15.04.20

FDA Warning Letter: Incoming Analysis of Raw Materials - Performing only an Appearance Test is not enough

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Danish drugmaker for serious GMP violations, including inadequate testing of finished products. Furthermore, the company failed to conduct at least one test to verify the identity of each component of a drug product.

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15.04.20

Warning Letter due to Non-Compliance with 3D Rule

A Chinese manufacturer has received a Warning Letter from the US-American FDA due to inadequate equipment design, deficiencies in monitoring and not performed laboratory tests as well as deficiencies in the Batch Record Review.

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15.04.20

Warning Letter: Lack of Repairs at US-American Manufacturer

A US-American pharmaceutical manufacturer of OTC solutions and suppositories has received a Warning Letter from the US-American FDA due to non-executed repairs and deficiencies in cleaning and laboratory testing.

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01.04.20

Brexit: New Notice to Stakeholders

EU has published a new Notice to Stakeholders on the withdrawal of the UK which summarises the most important aspects in three parts.

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