In the Pharmacopeial Forum, PF 49(5), two USP chapters related to volumetric apparatus were published for comments. It is proposed to make several changes in Chapter <31> Volumetric Apparatus. Furthermore, a new general chapter <1331> Use and Calibration of Volumetric Apparatus has been developed.
In the GMP environment one often talks about critical data. The term "critical data" only appears in a few places in the EU GMP Guidelines and their annexes and is also not clearly defined. How does one deal with this?
At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) has published a newly prepared GDP relevant document. The German-language resource entitled "Inspektion der Eignung von Transportprozessen" focuses on transport verification and its inspections by the competent authorities.
The required storage conditions for medicinal products must always be met. If deviations are discovered after the product has left the warehouse, a recall may be the consequence. This is shown by an example from the US, which is about possible pest control problems and temperatures in excess of the storage condition instructions on the product labeling.
The U.S. Food and Drug Administration (FDA) has published a new guidance document entitled "Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies". The document focuses on the enforcement of the enhanced drug distribution security requirements that will become effective on 27 November 2023. The authority grants a one-year extension as it does not intend to take action to enforce the requirements until 27 November 2024.
The FDA has published its considerations regarding CGT products in a new draft guidance. The purpose of this guidance is to provide recommendations for managing manufacturing changes and assessing comparability for both investigational and approved human CGT products, taking into account the unique challenges that apply to these products.
In the Pharmacopeial Forum, PF 49(5), revisions of USP chapters <761> Nuclear Magnetic Resonance Spectroscopy and <1761> Applications of Nuclear Magnetic Resonance Spectroscopy are being proposed. Based on the comments received, the previous proposals published in PF 48(4) have been canceled.
In the Pharmacopeial Forum, PF 49(5), a proposal of a revised USP General Chapter <701> Disintegration has been published for comments. The chapter was updated as part of the process of international harmonization of the European, Japanese, and United States pharmacopeias. The comments period runs from 01 September to 30 November 2023.
The FDA uncovered serious deficiencies in the aseptic area during an inspection of a US manufacturer. Deficiencies in smoke studies, media fills, pressure monitoring and cleaning validation are listed.
The FDA is currently working on approaches to strengthen its oversight in regard to the safety of cosmetic products. Therefore, the agency issued a draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products.