GMP News - Inspections/Audits

09.06.21

International Inspections: TGA and the Management of GMP Compliance Signals

The Australian Therapeutic Goods Administration (TGA) has published a guidance on the management of so-called GMP compliance signals for domestic and foreign manufacturers of medicinal products and biological products.

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02.06.21

Problems at Emergent BioSolutions Plant even worse

You can't actually believe what you read in the Form 483 that the FDA issued to the Emergent BioSolutions site in Baltimore - the site that suffered a mix-up in the manufacture of a Covid-19 vaccine.

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01.06.21

FIFO, FEFO, LIFO: What is the meaning?

FIFO, FEFO and LIFO are the three main strategies for warehouse management. But what do the three abbreviations actually stand for and what exactly do they mean?

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26.05.21

FDA updates Q&A Guidance on Inspections and Applications

After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and  Drug and Biological Product  Inspections During COVID-19 Public  Health Emergency Questions and Answers Guidance for Industry" with some further clarifications.

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12.05.21

MHRA establishes own GMDP Database

The UK MHRA has established a new GMDP database with information issued by the MHRA and from EudraGMDP relating to manufacturing, wholesale authorisations and certificates and non-compliance statements.

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12.05.21

FDA Report on Impact of Pandemic on Inspections

From March 2020 to March 2021, the FDA carried out 821 mission-critical inspections, but only 49 of these were in the area of "Human Drugs". A recent report provides details and an outlook.

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06.05.21

ATMP - Critical Deficiencies during an Inspection in the Netherlands

An inspection by the Dutch authority in February revealed a number of deficiencies at a manufacturer of advanced therapy medicinal products (ATMPs). The Non Compliance Report that was published shows which of these were critical.

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05.05.21

FDA Warning Letter for Colombian API manufacturer

In April 2021, the U.S. FDA issued a Warning Letter to a Colombian API manufacturer due to significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs).

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28.04.21

Covid-19 Vaccine Mix-Up in the US - what's behind it?

It has been recently reported in the press that there was a mix-up in the manufacturing of the J&J Covid-19 vaccine at a contract manufacturer. Already one year before, considerable quality deficiencies were found at the site. Now the site had to stop producing for now.

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27.04.21

GDP-Non-Compliance-Report for German Wholesale Distributor

The Competent Authority of Germany (Bezirksregierung Düsseldorf) has entered a new GPD Non-Compliance Report dated into the EudraGMDP database due to serious GDP violations at a German wholesaler. The case involves trading of falsified medicinal products and storage of expired medicinal products in regular stock. Furthermore, there are doubts on the reliability of the Reponsible Person and the CEO due to an ongoing criminal procedure.

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27.04.21

GDP Non-Compliance Report for Romanian Wholesale Distributor

The competent authority of Romania (National Agency for Medicines and Medical Devices of Romania) has entered a new GPD Non-Compliance Report dated 15 April 2021 into the EudraGMDP database.

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21.04.21

FDA publishes Guidance for Remote Interactive Evaluations - but not to replace Inspections

Teleconferencing, livestreaming sessions and screen-sharing technologies will be used by the FDA in future remote evaluations- but these remote evaluations will not be considered inspections.

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21.04.21

MHRA conducted over 750 Inspections remotely

A blog of the MHRA allows interesting insights into the current inspection practice of the authority and describes advantages and disadvantages of distant assessments.

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14.04.21

FDA Warning Letter to Mexican Manufacturer based on Review of Documents

The U.S. Food and Drug Administration (FDA) recently published a Warning Letter to a Mexican firm whose facility is registered as a manufacturer of over-the-counter (OTC) drug products in the United States. The Warning Letter is not based on inspection findings from an onsite audit but on the review of documents that the company was required to send at the request of the FDA. The FDA found different serious deficiencies based on the submitted documents.

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07.04.21

Poor Documentation Practice caused U.S. FDA Warning Letter

In March 2021, the U.S. FDA issued a Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products called "Foshan Biours Biosciences Co., Ltd." due to significant violations of cGMP regulations for finished pharmaceuticals.

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