GMP News - Inspections/Audits

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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31.03.21

MHRA starts combined Distant / On-Site Inspections

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is launching a sensible and likely workable approach to resuming domestic inspections - a combination of distant and on-site inspections.

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17.03.21

EU accepts MHRA inspections

The EMA has updated its Q&A document on the implementation of the Protocol on Ireland and Northern Ireland and clarified the recognition of inspections.

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17.03.21

FDA stops another Delivery of Hand Sanitizer at the US Border

The U.S. Food and Drug Administration (FDA) has once again stopped a delivery of hand sanitizers with too low alcohol content. The Mexican manufacturer received a Warning Letter.

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03.03.21

APIC: Annual Update of the ICH Q7 "How to do" Document

Version 14 of the "How to do" Document - Interpretation of the ICH Q7 Guide and "Review form" for APIs, which has been available since the beginning of the year, mainly includes additions and updates in the chapters 11, 15 and 16. The How to do document is intended to facilitate the implementation of the ICH Q7 Guide and lists recommendations on how to interpret it.

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03.03.21

FDA criticises Supplier Qualification in Warning Letter

Although the FDA currently conducts virtually no inspections, Warning Letters continue to be issued; in January, for example, to a pharmaceutical manufacturer in Florida.

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24.02.21

Inspection of biotechnological Manufacturers - PIC/S AiM Updated

In January, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a revised version of its Aide Memoire "Inspections of Biotechnology Manufacturers".

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