GMP News - Quality Assurance

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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12.05.21

New Version of WHO Guidelines on Process Transfer Published as a Draft

The WHO has recently published a new version of its guidelines on the transfer of technology as a draft. Many new chapters have been added to the previous document.

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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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28.04.21

EMA confirms full functionality of CTIS - on track to go live January 2022

Last week, the EMA confirmed that the clinical trial EU Portal and Database (Clinical Trial Information System (CTIS)) is now fully functional and on track to go live by 31 January 2022.

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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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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

Illegal Selling of CBD-Products: FDA Continues Issuing Warning letters

The FDA still warns companies for illegal selling Over-the-Counter CBD Products for pain relief including products listing CBD as an inactive ingredient.

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14.04.21

Switzerland aims to Facilitate Access to Medicinal Cannabis

The Swiss Narcotics Act is to be amended. Among other things, the amendment provides that cannabis-based treatments can be prescribed directly by doctors without having to obtain an exceptional authorization from the Swiss Federal Office of Public Health. In addition, cultivation and export are to be permitted.

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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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07.04.21

Revised Ph. Eur. Chapter 3.2.9. Rubber Closures

A general revision of Ph. Eur. Chapter 3.2.9 "Rubber Closures" has been proposed in Pharmeuropa 33.2. In particular the proposal includes changes to the sections regarding composition changes and extractable elements, functionality & fragmentation testing.

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07.04.21

Supplier Qualification for Packaging Material

USP´s Packaging and Distribution Joint Subcommittee posted a proposal for the development of a new General Chapter <1xxx> Supplier Qualifications.

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07.04.21

EMA: Revision of Q&A Documents regarding the Centralised Procedure

The latest versions of the two Q&A documents relating to the centralised procedure have each been supplemented by a question regarding the importation of finished medicinal products into the European Union.

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07.04.21

UK Recognition of EU/EEA Batch Testing does not end on 1 January 2023

A letter from the UK government to medicines and medical products suppliers extends the transitional phase for the recognition of EU batch tests beyond 2022.

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