FDA Warning Letter for Chinese Company based on Review of Records
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals. The firm failed to conduct proper analytical testing of incoming API lots and relied solely on supplier COAs without verifying the information. Additionally, there was a lack of documentation for the stability program.
EDQM: Addendum 11.5 to the European Pharmacopoeia available
The Supplement 11.5 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on 01 July 2024. All CEP holders are required to harmonise their specifications and thus the respective CEPs with the new monographs.
FDA Warning Letter for not answering a Request for Inspection
We recently reported on a case in which the failure to respond led to a Warning Letter. The U.S. Food and Drug Administration (FDA) has now published another incident that also goes in this direction. The FDA had planned an inspection at a manufacturing facility in Thailand, but all efforts to contact the firm were unsuccessful.
EMA publishes ICH Q14 Guideline on Analytical Procedure Development - Step 5
On 26 January 2024, the European Medicines Agency (EMA) has published the ICH Q14 Guideline on analytical procedure development - Step 5. The date for coming into effect is 14 June 2024.
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".
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.
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.
Two FDA Warning Letters: Identity Testing of Incoming Components
The U.S. Food and Drug Administration (FDA) has published two new Warning Letters to companies registered as a manufacturer of over-the-counter (OTC) drug products in the United States. In both cases, the firms did not demonstrate that they adequately tested each shipment of each lot of the incoming components at high-risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination.
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.
Revision of USP Chapter <1053> Capillary Electrophoresis Published for Comments
In the Pharmacopeial Forum, PF 50(1), a new version of USP Chapter <1053> Capillary Electrophoresis was published. Comments can be submitted until 31 March 2024.
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.
Failure to Respond to Multiple FDA Requests leads to Warning Letter
Not responding to FDA requests for records related to drug manufacturing and product quality is not a good idea, as can be seen by a recently published Warning Letter.
FDA Warning Letter to Turkish Manufacturer of Drugs, Cosmetics and Detergents
Even with increasing distance to the pandemic situation, manufacturers of disinfectant products still seem to be relying on less stringent controls. After a large number of Warning Letters regarding hand sanitizers with contaminated or poorly analyzed products in the Americas and Southeast Asia, a Turkish company is now affected. The company Sudesan in Istanbul received a Warning Letter from the FDA listing several deviations.
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.
FDA Publication on Elemental Impurities in Cannabis following Vaporization
Following the previously issued article on microbial contamination, authors from the FDA recently published an article on elemental impurities in cannabis following vaporization. The results indicate that a transfer of heavy metals from cannabis material to cannabis vapor may not occur during the vaporization process under the applied study conditions.