pharma Tag

Revision of Chapter 4 – Documentation

Chapter 4 has been revised to underline the importance of documentation in GMP compliance and incorporate support for new technologies, hybrid solutions, and new services in documentation management. Risk management principles are now focused and integrated into the data governance system to ensure the accuracy, integrity, availability, and legibility of documents in all types of formats (paper, digital, or hybrid).  The guideline also clarifies the requirements for managing electronic records, signatures, and data integrity, ensuring consistency with the concurrent revision of Annex 11.

Revision of Annex 11 – Computerised Systems

The revision of Annex 11 introduces stricter requirements for the life cycle management of computerized systems, requiring the full application of Quality Risk Management principles during all steps. The updated provisions consolidate the obligations relating to the definition and ongoing maintenance of system requirements and the oversight of suppliers and external service providers. Furthermore, the controls relating to data integrity, audit trails, electronic signatures, and system security have also been tightened.

New Annex 22 – Artificial Intelligence

The new annex about Artificial Intelligence sets out requirements for the use of AI and machine learning in the manufacturing of active substances and medicinal products and defines requirements for the selection, training and validation of AI models. Aspects related to defining the intended use of the model, defining performance metrics, the quality of model training data, and the management and processing of test data have been explored in depth. The document also provides for continuous oversight of AI systems, including change control, model performance monitoring, and human review procedures.

Taken together, these three documents aim to provide a comprehensive and robust framework that supports the implementation of information technology in pharmaceutical manufacturing, while maintaining product quality and patient safety.

SOURCES:

https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en

〈1079.5〉 Transportation Lane Temperature Mapping and Qualification

The General Chapters—Packaging and Distribution Expert Committee has proposed a new chapter addressing the evaluation and qualification of transportation routes to ensure appropriate storage conditions during distribution.

The transportation environment is critical to product preservation and is often outside the direct control of the shipper, including manufacturers, distributors, freight forwarders, and healthcare providers.

It is well known that transport presents specific risks due to the environmental variability to which the products may be exposed and the limited control through the distribution network.

This chapter outlines best practices for temperature lane mapping and transport route qualification to ensure the integrity of pharmaceutical products.

This new chapter formalizes lane-level risk management in pharmaceutical distribution and will have a direct impact on logistics service providers, distributors and manufacturers relying on ambient or temperature-controlled transport, requiring more rigorous oversight and documented evidence of distribution integrity.

Companies must establish mapping protocols, qualify critical routes, and integrate lane performance into their GDP and change control systems to ensure smooth operations.

Also published in this issue of PF is a Stimuli article, Transportation Lane Temperature Mapping and Qualification—Risk Identification and Evaluation, that provides additional background and context for the development of this chapter.

SOURCES:

The complete draft is available on the official USP website. Public comments are accepted until 30 November 2025

The European Pharmacopoeia has revised chapter 3.2.1. “Glass containers for pharmaceutical use”.

The revision was issued to clarify the purpose of tests A, B, and C used to define the type of glass and characterize the hydrolytic resistance of the glass. The presentation of the information (Table 3.2.1-1) has been modified to add further details about each test and its respective purpose.

The second update concerns the approach used to determine the maximum transmission limit for colored glass containers. Since the light protection or light transmission of a coloured glass depends on the wall thickness of the containers, it was decided to base the determination of the maximum spectral transmission and related specifications on the wall thickness insteadof the volume and closure system of the containers. The proposed limits take into account detailed data on containers available on the European market.

SOURCES:

https://www.edqm.eu/en/-/ph.-eur.-publishes-revised-general-chapter-3.2.1.-glass-containers-for-pharmaceutical-use-in-pharmeuropa-37.3