GMP News - Quality Assurance

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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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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