FDA Warning Letter to Indian Manufacturer: Glycerine used in Manufacturing not Tested according to USP
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an Indian company, registered as a manufacturer of OTC and homeopathic drug products. Some of the formulations contain high percentages of glycerin, but this high-risk component was not adequately tested according to the USP requirements. Thus, it was not ensured that the relevant safety limits for the levels of diethylene glycol or ethylene glycol were met.
FDA Warning Letter to Californian Drug Manufacturer
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a drug manufacturer in California. The FDA blames the company of various CGMP violations, particularly in the areas of release testing, sampling, stability testing and process validation.
Laboratory Data Integrity issues once again caused a Warning Letter
In February 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Dunagin Pharmaceuticals Inc. dba Massco Dental" after having inspected its site in Arkansas in August/September 2022.
The International Pharmacopoeia (Ph. Int.) is available online. It has legal status, whenever a national or regional authority refers to it in appropriate legislation. Now, the 11th Edition of the Ph. Int. has been published.
New JP Ultraviolet-Visible and Infrared Reference Spectra Published
In March 2023, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published the "JP Drafts (March 2023) No.2 ". In this context, five new Ultraviolet-visible and Infrared reference spectra were published.
Four JP Drafts Related to Balances Published for Public Comments
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Balances. Comments can be submitted until 31 March 2023.
USP: New General Chapter Supplier Qualification <1083>
On August 01, 2023, the new USP Chapter "<1083> Supplier Qualification" will officially enter into force. In the USP Forum, the draft chapter could be viewed and commented on until the end of November 2021.
Another FDA Warning Letter to US Manufacturer of Hand Sanitizers
The U.S. Food and Drug Administration (FDA) has once again published a Warning Letter to a US manufacturer of hand sanitizers. During an inspection, several CGMP violations were found. In addition to inadequate release testing in general, the finished products are likely to be contaminated with methanol.
EDQM: Supplement 11.2 of the European Pharmacopoeia available
Supplement 11.2 of the European Pharmacopoeia (Ph.Eur.) is now available. This supplemental edition lists several updated monographs that will be implemented on 01 July 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia holders) are encouraged to align their specifications and thus the respective CEPs to the new monographs.
The U.S. Food and Drug Administration (FDA) sent a Warning Letter to a drug manufacturer in Istanbul. During an inspection, several CGMP violations were found. Among other things, this concerns identity testing of incoming components, process validation and stability testing.
On the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare), the list of available reference standards is updated at regular intervals. It indicates which reference substances have been replaced by new batches and which standards have been removed from the list of reference substances (since January 2023) or will be deleted in the future (as of April or July 2023).
The Series of Warning Letters to Manufacturers of Hand Sanitizers does not stop
Even after many pandemic measures have expired, and although shortages in hand sanitizer supply are no longer of such high concern, the aftermath still seems to linger in the form of poor quality management in manufacturing, according to a new warning letter from the FDA.
Comments on FDA Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence published
In December 2022, the U.S. Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence". Comments and suggestions could be submitted until 04 February. After this deadline, the comments received have now been published.