Pharmaceutical Engineering Magazine

As the pharmaceutical industry faces ever-changing global challenges and market forces, it must review and revise product design to ensure that quality products remain available in the marketplace while moving toward zero pollution for air, water, and soil. This article provides an introduction on how quality products can integrate sustainability by design.

This article explores life-cycle activities for machine learning (ML) within regulated life sciences. It positions and contextualizes the life cycle and management of the machine learning subsystem or components within a wider system life cycle. It also gives general descriptions and guidance illustrated by a case study demonstrating a machine learning application to medical image recognition, or software as a medical device (SaMD).

Many organizations are evaluating how advanced therapy medicinal products (ATMPs) and other traditional modalities may be combined within the same facility or within a newly constructed agnostic building. This article outlines a broad framework to evaluate different types of modalities that may be accommodated concurrently and then uses a case study to explain how the approach may be applied to an existing facility.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4) offers advantages in the consistent format of the registration dossier using the Common Technical Document (CTD). However, it does not deliver a comprehensive view of the overall manufacturing control strategy or a means of understanding and managing the quality of the product throughout its life cycle. As a result, several regulatory authorities that have implemented the CTD format have also insisted on supplementary quality summary documentation that exceeds ICH requirements, and, in effect, creates divergent expectations for chemistry, manufacturing, and controls (CMC) content. A single global quality overall summary (QOS) format could clearly convey a holistic view of a product’s control strategy and improve the efficiency and economy of the regulatory review of an application while providing a way for the applicant and reviewer to align on a product life-cycle management plan.

ISPE held an Expert Xchange on 18 January 2022 that included presentations and interactive exercises that generated new and useful insights into the current effectiveness of the knowledge that flows into QRM and how a knowledge map can be used to diagnose opportunities to improve KM. The exercises also helped identify the types of knowledge generated during QRM. These insights demonstrated the opportunity to improve risk-based decision-making by uniting risk and knowledge through a suitable framework such as the Risk-Knowledge Infinity (RKI) Cycle.

Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to constantly meet evolving program requirements set in the product’s preclinical; clinical; chemistry, manufacturing, and controls; and market strategies. A key enabler to success is establishing a robust yet nimble viral vector manufacturing platform that delivers high-quality product on time and in full while managing cos

This article aims to refresh information on open-source software (OSS) within regulated computerized systems that was first discussed in an article in May-June 2010 Pharmaceutical Engineering®. The adoption of OSS advanced since then, and the article explores the importance of recognizing when an organization is relying on OSS and the benefits and risks this brings from a GAMP® 5 perspective.