GMP News - Quality Assurance

07.02.24

New FDA Warning Letter because of inadequate Quality Oversight

The FDA recently issued a Warning Letter to a pharmaceutical company in Thailand for violating CGMP regulations and expectations on Quality Oversight.

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07.02.24

EMA/CMDh: Nitrosamine Q&A Document revised

The EMA/CMDh nitrosamine Q&A document "Questions and answers for marketing authorisation 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" was updated again in January 2024 and is now available in revision 20. Like the three appendices, the Q&A document is published on the EMA website and can be viewed under "Questions and answers".

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31.01.24

EDQM: Overview of Reference Substances updated

The list of available reference standards is revised and published at regular intervals on the website of the EDQM. This comprises more than 3100 substances, including not only chemical reference substances but also herbal reference standards and biological reference preparations as well as reference spectra for carrying out tests and trials in accordance with Ph. Eur. methods.

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31.01.24

EDQM: Comments on the Nitrosamine Monograph possible

The updated text of the monograph "2.5.42. N-Nitrosamines in active substances and medicinal products" has been published on the website of the EDQM in the Pharmeuropa section and can be commented on until 31 March 2024, along with several other new drafts.

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31.01.24

FDA seeks Participants for the next Phase of the Quality Manufacturing Maturity Programme

The FDA wants to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements!

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31.01.24

FDA Office of Compliance - Annual Report FY 2023 Published

The FDA Office of Compliance Annual Report Fiscal Year 2023 provides a detailed overview of various initiatives, primarily focused on inspections, quality, and Good Manufacturing Practice (GMP) compliance. Read more in our GMP News article.

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25.01.24

New Ph. Eur. Chapter Comparability of Alternative Analytical Procedures

Following the draft chapter published in 2022, the new Ph. Eur. general chapter Comparability of alternative analytical procedures (5.27) has now been published in Supplement 11.5.

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24.01.24

FDA Warning Letter: Testing of incoming Goods

In January 2024, the U.S. FDA issued a Warning Letter to the company "Prime Lab LLC" after having inspected its site in July and August 2023. According to the WL, the firm failed to do proper incoming control tests for identity of their raw materials.

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23.01.24

Now Available: Reference Standards for the new Ph. Eur. Cannabis/CBD Monographs

The new Ph. Eur. Cannabis Flower and CBD Monographs require the use of specific reference standards/substances. These reference standards/substances are now available.

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17.01.24

Ozempic Falsification also in the US

Following the previously confirmed falsifications of Ozempic® batches in the EU drug supply chain, the FDA now warned consumers not to use counterfeit Ozempic® found in the US drug supply chain.

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17.01.24

FDA Warning Letter: Missing Stability Studies

In December 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Inopak, Ltd." after having inspected its site in July and August 2023. According to U.S. FDA Warning Letter, the firm failed to maintain an ongoing stability program for their drug product.

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17.01.24

FDA Launches Electronic Submission Portal for Cosmetics

The FDA issued the final guidance on cosmetic product facility registrations and product listings, as mandated by the MoCRA. Amongst others, the guidance contains information about a new electronic registration and listing submission portal: Cosmetics Direct which is now available.

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17.01.24

Who should review a Batch Record?

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to do so?

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17.01.24

Additional Submission Tools for Cosmetic Product Facility Registration and Product Listing

The FDA announced the availability of SPL Xforms, a Structured Product Labeling (SPL) authoring tool for cosmetic product facility registration and cosmetic product listing. In addition, paper forms are now available.

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10.01.24

EMA/CMDh: Update Q&A Document for Nitrosamines

The current version of the EMA/CMDh nitrosamine Q&A document "Questions and answers for marketing authorisation 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", dated October 2023, contains Annex 1 and three further appendices (Appendix 1-3). In December 2023, Appendix 1 was updated and now contains five additional substances.

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