The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are updating their guideline for stability testing. ICH Q1, ‘Guideline on stability testing of drug substances and drug products Step 2b’, outlines the stability data expectations for drug substances and products. This guideline is applicable to marketed drug products, including those associated with registration and lifecycle/post-approval changes and, when applicable, master files. These applications are hereafter collectively referred to in the guideline as regulatory submissions. ICH Q1 is a consolidated revision that supersedes ICH Q1A-F and Q5C guidelines and provides additional guidance on principles relating to stability.
The European Medicines Agency (EMA) has proposed a revision to Good Manufacturing Practice (GMP) guidelines for Advanced Therapy Medicinal Product (ATMP) production - Concept paper on the revision of annex 1 of the guidelines on GMP - manufacture of sterile medicinal products.
The new proposal suggests updating to fall in line with Annex 1 updated standards. The proposal states that the current Part does not have up-to-date guidelines on using Quality Risk Management (QRM) and Contamination Control Strategy (CCS) concepts, as detailed in Annex 1.
The proposal is now up for public consultation, with a deadline for comments of 8 July.
The United States Pharmacopeia (USP) is proposing a new chapter based on the version published in PF 48(5) as ‘Solid Phase Cytometry-Based Rapid Microbial Methods for the Detection of Contamination in Short Shelf-Life Products’ - this appears in pharmacopeial forum 51(3).
This update will expand the chapter to clear aqueous solutions which are filterable and have a low level of inherent fluorescent background, e.g., water, ophthalmic solutions, saline solutions, etc.
The scope of this chapter is based on the actual data reviewed by USP and for which there is a confidence on an appropriate utilisation of the method and data analysis.
Comments are open until the end of July 2025. Registration is required.
The mycoplasma testing requirements in the USP is under review to include the validation and testing of qualitative Nucleic Acid Amplification Tests (NAATs) for the detection of Mycoplasma contamination.
Comments are open until the end of July 2025. Access requires registration.
The USP is developing a new chapter: 〈1037〉 Process Analytical Technology - Theory and Practice. The objective is to establish a comprehensive guide that aligns with current scientific and regulatory standards, providing clear direction for the implementation of PAT within pharmaceutical companies. This is designed to ensure the continued advancement and quality of pharmaceutical manufacturing. The proposal contains the following key elements:
1. To introduce the concept of PAT and its significance in the pharmaceutical industry. Discuss the evolution of PAT and its critical role in enhancing product quality and manufacturing efficiency
2. To provide a detailed definition of PAT, along with an exploration of its core attributes. Emphasise the necessity of timeliness, sampling relevance, regulatory implications, analytical measurement technology, integration and the relevance of process and product attributes
3. To discuss the various enablers that facilitate the effective use of PAT, including sensors, analysers, data-driven modelling (including chemometrics, machine learning and artificial intelligence), process automation, IT system integration, automated sampling technology, design of experiments (DOE) and risk assessment methodologies (such as Failure Mode and Effects Analysis (FMEA)).
Guidance on implementing robust PAT applications in pharmaceutical manufacturing facilities will be provided. This includes strategies for integrating PAT tools with existing systems, data management and the use of PAT in process development, scale-up, and manufacturing
4. To detail the life cycle management of PAT, which is essential for PAT method development and validation, ensuring ongoing performance evaluation throughout the application's life cycle. Detail continuous monitoring and assessment of PAT method performance, with a robust plan for monitoring, analysing and adjusting the method. The life cycle approach is crucial, as PAT method risk assessment must consider the product life cycle stage and data usage to maintain quality consistency throughout the product life cycle
5. To present an overview of the regulatory landscape, highlighting how PAT aligns with current guidelines and standards. This section will discuss the implications of PAT on regulatory submissions and compliance
6. Review emerging trends and technologies in PAT, discussing potential future directions and innovations in the field
Comments are open until the end of July 2025. Access requires registration.
The USP is developing a chapter titled 〈1664.2〉 ‘Parenteral Drug Products (Intramuscular, Intravenous, and Subcutaneous).’ It is proposed to add this new chapter as a companion to ‘Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 〈1664〉.’
The new chapter addresses specific considerations for leachables in Parenteral Drug Products (PDPs), focusing on injections administered by intramuscular, intravenous and subcutaneous routes. The chapter is primarily devoted to organic leachables - consideration of inorganic (i.e., elemental) leachables being reserved for chapter 〈1664〉.
There is a particular focus on single use systems.
Comments are open until the end of July 2025. Access requires registration.
There is a difference between the USP's controlled room temperature definition (20°-25°C, with excursions permitted within the range of 15°-30°C) and the room temperature ranges defined by the European Pharmacopoeia (EP) which is 15°–25°C.
A new stimulus chapter in the USP discusses this topic. This is titled “Aligning Room Temperature Standards for Pharmaceuticals - A Sustainable Approach”. Access requires registration.
The chapter is set to go live later in 2025.
USP Chapter 1 is undergoing a revision. Included among the revision details is the following statement:
‘A specific and stability-indicating test should be used to determine the strength (content) of the drug product. In cases where the use of a nonspecific assay is justified, other supporting analytical procedures should be used to achieve overall specificity. A specific procedure should be used when there is evidence of excipient interference with the nonspecific assay.’
The chapter is set to go live later this year.
A draft chapter is in preparation within the USP to provide a comprehensive overview of considerations for the development of cell-based advanced therapies and tissue-based products. In addition, a collection of terms commonly used in this field is provided in the glossary.
This is 〈1046〉 Cell-Based Advanced Therapies And Tissue-Based Products.
Cell-based advanced therapies and tissue-based therapies are medical products that contain human or animal cells that will be administered to humans to repair, replace, regenerate or augment a recipient’s cells, tissues or organs that are diseased, dysfunctional or injured. The source cells or tissues can be harvested for use without manipulation or may be propagated, expanded, pharmacologically treated or otherwise altered in biological characteristics ex vivo before administration.
The chapter is set to go live later in 2025.
The current growth-based sterility tests, with an incubation period of at least 14 days, are not suitable for products with a short shelf-life or for products prepared for immediate use. These are usually infused into patients due to clinical needs before completion of the sterility test - e.g. Compounded Sterile Preparations (CSPs), nuclear medicine products and Advanced Therapy Medicinal Products (ATMPs).
The utilisation of rapid microbiological methods to detect microbial contamination should be risk-based, so the stakeholder can select the preferred technology for the intended use whilst balancing User Requirement Specifications (URS) that include time to result, specificity, Limit of Detection (LOD), sample size and product attributes.
For example, many radiopharmaceuticals would benefit from the use of a real-time microbiological test due to the short half-life of radiotracers, while CSPs and autologous cell therapies would benefit from an overnight test.
A draft USP chapter sets out a risk-based process to determine how rapid microbiological methods might be implemented. This is 〈1071〉 ‘Rapid microbiological methods for the detection of contamination in short-life products - a risk-based approach’.
The chapter is set to go live later in 2025.
The USP is updating its guidance for the effective operation of microbiology laboratories - 〈1117〉 Microbiological best laboratory practices. The change is primarily in relation to the adoption of rapid microbiological methods. The chapter is set to go live later in 2025.
ISO 10993-1 (‘Biological evaluation of medical devices, Part 1: Evaluation and testing within a risk management process’) is undergoing major revision, with significant updates to device categorisation, contact duration definitions, required biological effects and its integration with ISO 14971. These changes will require thorough gap assessments, updates to existing Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs), and, in some instances, additional biological testing or scientifically justified waivers for newly introduced endpoints.
The Final Draft International Standard (FDIS) ISO 10993-1 was circulated for ballot on 22 May 2025 and is expected to be published by year-end. Although currently a draft, no further technical or scientific revisions are expected - only editorial adjustments.
The U.S. Food and Drug Administration (FDA) has updated its guidance on Abbreviated New Drug Application (ANDA). These contain data which is submitted to FDA for the review and potential approval of a generic drug.
This new final guidance explains how to lock in the eight months priority review goal for eligible ANDAs through a complete, timely Pre-Submission Facility Correspondence (PFC).
This guidance describes the facility information to be submitted in a PFC and how the FDA will use this information to set a review goal for an ANDA. This guidance incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorisation of the Generic Drug User Fee Amendments (GDUFA) and as described in ‘GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027’ (GDUFA III commitment letter). This guidance finalises for implementation the draft guidance of the same title issued on December 5, 2022.
To access, see: https://www.fda.gov/media/187029/download
Sign up now and receive our regulatory update via email every month hassle free.
