GMP News - Quality Assurance

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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20.12.23

EDQM: Updates on CEP Dossiers

With regard to the "CEP 2.0", the EDQM has once again provided information on the "EMA SPOR/OMS ORG_IDs" and "LOC_IDs" ("unique identifiers for an organisation" / "unique identifiers for its locations") on its website.

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20.12.23

US Track & Trace Guidance on Verification Systems

The FDA issued the final guidance on verification systems under the DSCSA. The document covers "suspect drug systems" that trading partners must have in place to detect and respond to suspect drugs and ultimately notify the FDA if needed.

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20.12.23

Does a Defect Rate of 0.011% justify a Warning Letter?

In a recent Warning Letter from the US FDA, the authority refutes a medicinal product manufacturer's argument that a failure rate of 0.011% does not trigger further action. How does the FDA argue here?

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13.12.23

EU and MHRA extend GMP and GDP Certificates

The validity of EU GMP and GDP certificates is to remain in place until 2024 or until the completion of the next on-site inspection, whichever comes first. Until then, supervision will be performed risk-based.

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13.12.23

ICH Q9 Training Package for Revision 1 published

Since 2005, the ICH Q9 Guideline has been the state of the art when it comes to quality risk management. It was initially included in the EU GMP Guidelines as Annex 20 and was then incorporated into Part III. In addition, an ICH Q9 "briefing package" was developed and made available on the ICH website. New training material is now also available for Revision 1 of the ICH Q9 Guideline.

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07.12.23

Falsification of Ozempic Confirmed

Following the recent concerns that falsified batches of Ozempic® may have entered the market, the Official Medicines Control Laboratory (OMCL) Chemisches und Veterinäruntersuchungsamt (CVUA, Karlsruhe, Germany)  has determined that suspected batches of Ozempic® pre-filled pens contained insulin glulisine instead of the claimed active substance, semaglutide.

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06.12.23

Further Warning Letters after Remote Evaluations by FDA

Two pharmaceutical companies had received a Warning Letter from FDA without ever having been inspected on site. This was purely on the basis of a remote evaluation.

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06.12.23

China tightens Counterespionage Law - Risk for Audits and Inspections?

China has passed a revised counter-espionage law that extends the powers to combat espionage. This increases the legal uncertainty for GMP inspections and audits.

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30.11.23

Swissmedic Clarifies GMP Requirements for Formula Drugs

The Swissmedic recently clarified some requirements for the manufacture and marketing of formula drugs (e.g. "Formula magistralis" medicinal products) by issuing an updated version of their corresponding guidance document. The guideline is the basis for "GMP inspections for formula drugs" carried out by the cantonal inspectorates and Swissmedic.

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29.11.23

FDA Delays Requirements for Cosmetic Facility Registration and Product Listing

The U.S. FDA issued a guidance on the delay of enforcement of the requirements for cosmetic product facility registration and cosmetic product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.

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29.11.23

EMA: Q&A documents on the topic of "Centralised procedures" revised

In September and November 2023, the "Questions & Answers (Q&A)" documents relating to centralised authorisation procedures were revised once again and published on the website of the European Medicines Agency (EMA). The Q&A catalogues, which can be used by marketing authorisation holders and applicants for centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application.

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21.11.23

FDA Warning Letter: Inadequate Quality Systems

The U.S. FDA issued a Warning Letter to the US American company "ALI Pharmaceutical Manufacturing, LLC" after having inspected its site in September/October 2022.

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21.11.23

Supplier Questionnaires and their Way into a FDA 483

A recently published 483 for a sterile manufacturer shows once again that the issue of supplier control is an ongoing concern for the US FDA. However, this is not the only focus in this report, as there are 13 other, sometimes detailed (and hair-raising) observations over 20 pages.

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