In recent months, the awareness for the impurities diethylene glycol (DEG) and ethylene glycol (EG) in pharmaceutical products was increased due to several FDA Warning Letters. We have reported on different examples where manufacturers failed to conduct proper identity testing of glycerin and other high-risk components. Now two more Warning Letters have been published, which also deal with this issue.
The FDA published the final guidance on annual status reports and other submissions for postmarketing requirements (PMRs). The reports are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on PMRs and postmarketing commitments (PMCs) in a consistent format.
The World Health Organization (WHO) published a draft guideline on best practices for clinical trials. The document is intended to provide guidance to WHO’s Member States and any staff members of non-State actor organizations whose work is related to clinical trials.
On 19 July 2023, the EMA (European Medicines Agency) published a Reflection Paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle. This document is open for comments until 31. December 2023. What is the content of the document?
Like the USP chapter "Balances <41>", the chapter "Weighing on an Analytical Balance <1251>" has been updated and revised. The new version of this chapter has now been posted on the USP Pharmacopeial Forum website for comment. Comments on this draft, which is based on the previous version from May 2018, can be submitted until 30 November 2023.
In the Ph.Eur. Supplement 11.4, the EDQM announces the deletion of the test for nitrate in Water For injection (WFI) and Purified Water if the test for conductivity meets the pharmacopoeial requirement for WFI. In addition, the use of recombinant factor C (rFC) to test for bacterial endotoxins will be allowed. Find out more about the changes in the Ph.Eur. Monographs Water for Injection (0169) and Purified Water (0008).
The World Health Organization (WHO) has published a draft working document on "WHO good practices for pharmaceutical quality control laboratories (QAS/21.882)". The deadline for submitting comments is 06 October 2023.
The FDA Warning Letters are a very good source to get to know how the FDA reacts to GMP deficiencies. In a current Warning Letter, the FDA comments on deficiencies in the context of process validation, among other things. What "CAPA" measures did it call for?
During GMP inspections, inspectors should first look at critical (computerised) systems. Neither the EU GMP Guide nor Annex 11 or 15 give clear guidance on how to identify such critical systems. How can a system be established within the company to identify the criticality of computerised systems?
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.
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?
In the last few days and weeks, the U.S. Food and Drug Administration (FDA) has published several guidance documents related to the requirements under the Drug Supply Chain Security Act (DSCSA). Under the DSCSA, trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) are subject to certain requirements for enhanced drug distribution security.
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.
To minimize possible disruptions in the distribution of certain prescription drugs in the United States, the FDA does not intend to take action before 27 November 2024 against dispensers who do not verify the product identifiers of suspect or illegitimate products.
Swissmedic is bringing a SwissGMDP database into operation, similar to the EudraGMDP database, listing GMP and GDP certificates of all companies in Switzerland.
Swissmedic plans to bring a SwissGMDP database into operation, which will list the GMP and GDP certificates of all companies in Switzerland with a valid establishment licence issued by Swissmedic. The database will make it possible to view the GMP/GDP status of a company easily and free of charge.
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 latest valid version of the USP chapter "Balances <41>" has been substantially revised and is now posted for comment on the USP Pharmacopeial Forum website. This revision follows updates to the USP chapter "Weighing on an Analytical Balance <1251>" and the general chapter "Balances" of the European Pharmacopoeia (Ph. Eur.). Comments on this draft can be submitted until 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 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.
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.
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.
