An important part of the ISO 14644 series of cleanroom standards has been revised – ‘ISO 14644-5:2025 Cleanrooms and Associated Controlled Environments, Part 5: Operations’. This is the second revision of the standard.
The standard addresses:
This document gives additional information in annexes for:
The standard can be purchased from ISO or through national standards bodies.
With the increasing integration of wireless, internet and network-connected capabilities, portable media and the frequent electronic exchange of medical device-related health information, the need for robust cybersecurity controls to ensure medical device safety is of paramount importance.
In relation to medical devices, the U.S. Food and Drug Administration (FDA) has published a new guidance document - ‘Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions’.
In recent years, increased connectivity has resulted in individual devices operating as single elements of larger medical device systems. These systems can include healthcare facility networks, other devices and software update servers, among other interconnected components. Consequently, without adequate considerations across all aspects of these systems, a cybersecurity threat can risk the safety and/or effectiveness of a device by compromising the functionality of any asset in the system.
The guidance can be accessed here: https://www.fda.gov/media/119933/download
Note: Edition 11.8 of the European Pharmacopeia is now live (July 2025).
Updates of note between 11.1 and 11.8 (i.e. 2025)
Chapters
Monographs
The 12th edition will be published in January 2026. Some key changes include:
Chapter updates:
Chapter removal:
The European Pharmacopeia has issued its programme of works. This will include:
Methods of analysis
General chapters
The Ph. Eur. is seeking stakeholder feedback on the revised general chapter ‘5.1.6. Alternative methods for control of microbiological quality’.
This chapter aims to facilitate the implementation of Rapid Microbiological Methods (RMM) - an expanding area of microbiology that is both innovative and diverse in nature. The revision of this chapter is part of the significant efforts made by the Ph. Eur. Commission (EPC) to support and accelerate the implementation of alternative RMMs, which are particularly beneficial for short shelf-life products.
The chapter has undergone significant revision to reflect current methodologies and update implementation guidance for these alternative methods. Responsibilities of suppliers and users are now clarified and new information is included to help users optimise implementation strategies by capitalising on suitable tests already performed and evaluating different implementation activities simultaneously. The primary validation subsection has also been updated, while the guidance on product-specific validation has been extensively revised.
The draft general chapter is accessible via Pharmeuropa (requires registration)
To help to boost representation in clinical trials, the FDA has issued a draft guidance titled ‘Inclusion of Pregnant and Breastfeeding Women in Clinical Trials’.
The objective of this guideline is to provide recommendations for the appropriate inclusion and/or retention of pregnant and/or breastfeeding women in clinical trials. This will help to facilitate the generation of robust clinical data, allowing evidence-based decision making on the safe and effective use of medicinal products by these women and their healthcare providers.
The document can be reviewed here: https://www.fda.gov/media/187755/download
The European Pharmacopoeia Commission (EPC) adopted three revised texts related to pharmaceutical waters during its 182nd session in June 2025. This constitutes a significant step forward in converging quality standards for the most widely used excipients in the pharmaceutical industry. The revised texts are:
These revisions, initially published for public consultation in Pharmeuropa 36.3, reflect the EPC’s commitment to modernising analytical methods. The most notable change is in the monograph on ‘Water for Injections’, where the conventional test for oxidisable substances was replaced with the more sensitive and non-selective Total Organic Carbon (TOC) test in the section on ‘Sterilised Water for Injections’. This shift enhances the detection of organic impurities and supports a more robust quality control framework.
In general chapter 2.2.44, the reagents sucrose R and 1,4-benzoquinone R were replaced with Chemical Reference Substances (CRSs) to streamline the application of the TOC test.
The revised texts will be published in Issue 12.3 of the European Pharmacopoeia in January 2026 and will enter into force on 1 July 2026.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on the use of bacteriophages (for use against pathogenic bacteria). The document contains regulatory guidance pertinent to the development of bacteriophage (also known as phage) therapeutic products.
Bacteriophages are viruses that can infect and destroy bacteria. The current understanding is that although bacteriophages cannot infect and replicate in human cells, they have a role in the human microbiome. Bacteriophages can have lytic (phage replicates, then breaks through the cell wall and destroys (lyses) the host cell) or lysogenic (phage DNA is incorporated into the host genome) lifecycles.
There is a history of use for bacteriophages in the eradication of bacterial infections, including those resistant to antibiotics. Bacteriophages may also be of use in the treatment of infections in individuals unable to tolerate traditional antibiotics.
ISO 15223-1 is an important standard for medical device manufacturers, providing symbols to convey information about devices without relying on text. This minimises translation needs, frees up label space and meets various regulatory requirements.
In 2025, ISO 15223-1:2021/Amd 1:2025 introduced a significant change to the Authorised Representative symbol, altering the [EC] part of the symbol to [XX]. This change allows the symbol to be used globally by replacing [XX] with country codes or other recognised text.
The updated standards are available from ISO or via a national standards institute.
The FDA’s Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality has published a white paper entitled ‘Quality Management Initiatives in the Pharmaceutical Industry: An Economic Perspective’. This document describes how strategic investments in quality management initiatives in the pharmaceutical sector have the potential to yield returns for companies and for public health.
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