FDA Warning Letter to Drug Manufacturing Facility in Thailand
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Thailand. The violations include failure to conduct appropriate laboratory testing for identity and strength of active ingredients prior to release and distribution.
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.
The final text for USP <383> Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components has been published in the USP. The chapter will become official on 1 December 2027. Early adoption of the requirements in this chapter is permitted by USP.
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.
After the ICH and the EMA had already made the documents available for download in December and January respectively, the FDA has now announced the availability of the final guidances for the industry entitled "Q2(R2) Validation of Analytical Procedures" and "Q14 Analytical Procedure Development."
FDA Draft Guidance on Potency Assays for Cellular and Gene Therapy Products
At the end of December, the FDA published a new draft guidance document on potency assays for Cell and Gentherapeutics. In addition to recommendations for potency testing, this guidance is also intended to help with the overall strategy for ensuring potency.
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.
Another FDA Warning Letter for Chinese Company based on Review of Records
The U.S. Food and Drug Administration (FDA) has issued another Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals, based on a review of records.
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.
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.
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".