GMP News - Quality Assurance

27.03.24

Court Ruling: Suspended Sentence and Heavy Fine for Falsifying Stability Data

A court in the UK has sentenced a pharmaceutical company and its former director to heavy fines. The defendant had admitted to knowingly submitting falsified stability data to the MHRA in order to obtain a Marketing Authorization for a product. This was preceded by years of investigation by the authority.

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19.03.24

EMA/CMDh: Appendix 1 for Nitrosamines Updated Again

The nitrosamine Q&A document "Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" of the EMA/CMDh contains three annexes (Appendix 1-3) in its current version of October 2023. In February 2024, Appendix 1 was updated again and fifteen new substances were added.

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13.03.24

APIs in Brazil: how to register and obtain the GMP certificate

In February 2024, the ECA offered the Live Online Training "How to register APIs in Brazil - Focus on CADIFA and obtaining a Brazilian GMP certificate". During the Q&A sessions, many interesting questions were posed to the speakers' team. A list of useful abbreviations and definitions in regard on the Brazilian registration system are collected and provided in the following.

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13.03.24

EDQM: Top Ten Deficiencies for CEPs

In February 2024, the EDQM has published its summary of the top ten deficiencies which occurred during the evaluations of the CEPs in 2023. This document called "TOP TEN DEFICIENCIES in New Applications for Certificates of Suitability for chemical purity" should help applicants to avoid such deficiencies in future and lists in detail the findings and its respective sections.

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13.03.24

FDA Warning Letter Defines Minimum Criteria for Process Validation

In addition to 21 CFR 210/211 and the related Guides to Inspection of as well as Guidelines/Guidances for Industry, Warning Letters are another way of interpreting the US cGMP regulations. Read more here about FDA's response to a pharmaceutical manufacturer's reference to not being aware of the need to perform process validation.

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12.03.24

How does GMP apply for Herbal Medicinal Products?

The EMA published revised Questions & Answers on the EU framework for (traditional) herbal medicinal products, including those from a “non-European” tradition. Amongst others two new interesting questions with corresponding answers regarding GACP and GMP have been introduced.

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12.03.24

Is it Acceptable to Mix Extract-Batches in order to Improve Batch-to-Batch Consistency?

A revision of the "Questions & answers on quality of herbal medicinal products/traditional herbal medicinal products" document was published on the website of the European Medicines Agency (EMA) on 1 February 2024.

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06.03.24

EMA/CHMP/CVMP: New Q&A document for the Use of CEPs

In the middle of February, the document "QWP Questions and Answers (Q&A): how to use a CEP in the context of a Marketing Authorization Application (MAA) or a Marketing Authorization Variation (MAV)" prepared by the EMA, the CHMP (Committee for Medicinal Products for Human Use) and the CVMP (Committee for Medicinal Products for Veterinary use) was published on the EMA website for the first time.

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28.02.24

What is an FDA Post-Warning Letter Meeting?

When reading an FDA Warning Letter, you might have recognised that under GDUFA programme, the facility may be eligible for a so-called Post-Warning Letter Meeting. But what is this?

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28.02.24

FDA Warning Letter: Data Integrity issues while manufacturing APIs

In February 2024, the U.S. FDA issued a Warning Letter to the Chinese company "Sichuan Deebio Pharmaceutical Co. Ltd." after having inspected its site in September 2023. According to the Warning Letter the firm has a lack of microbiology laboratory Data Integrity.

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28.02.24

FDA Guideline "Advanced Manufacturing Technologies Program" published as a Draft

The FDA defines advanced manufacturing as innovative pharmaceutical manufacturing technologies or an approach with the potential to improve the reliability and robustness of the manufacturing and supply chain. The FDA encourages the early adoption of such advanced manufacturing technologies and has established a programme for this purpose.

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21.02.24

What is the African Medicines Agency?

The EMA has received a grant of ten million euros from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA).

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21.02.24

EMA/HMA/ECA: List of Active Substances defined to prevent supply bottlenecks

As part of the measurements against supply shortages in the pharmaceutical sector, the first version of the "Union list of critical medicines" and further information on this was published on the EMA website at the end of last year. This list contains more than 200 active substances that are considered critical in the event of a supply shortage and whose shortage must be avoided at all costs.

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21.02.24

Swissmedic: Nitrosamine Requirements updated

Swissmedic's nitrosamine Q&A document "Update of the requirements for dealing with nitrosamine impurities in medicinal products" was updated in January 2024 and is now available in the new version on the Swissmedic website.

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14.02.24

FDA Warning Letter: Observed particulates in repackaged drug components

In January 2024, the U.S. FDA issued a Warning Letter (WL) to the Mexican company "Glicerinas Industriales, S.A. de C.V." after having inspected its site in May 2023. According to U.S. FDA Warning Letter, the firm failed to do adequate investigations on observed contamination of particles in numerous packaged drugs.

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