A recently released guidance document, the ISPE Guide: 503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies, summarizes and contextualizes key information from US governmental bodies relevant to...
On 17 April 2024 at the 2024 ISPE Europe Annual Conference in Lisbon, Portugal, a panel discussion titled “Harmonization to Break Down Barriers to Robust Supply Chains” featured an international panel of experts who discussed drug recalls, drug shortages, risks that can lead to poor drug product quality, quality risk management, Annex 1 implementation and its effect on the supply chain,...
Eli Lilly has recently achieved a remarkable milestone with the completion of its new synthetic peptide manufacturing facility/platform at its facility in Kinsale, Ireland. This cutting-edge project not only enhances production capabilities but also exemplifies a commitment to innovation and safety. Below is an overview which delves into the details of this groundbreaking achievement and...
ISPE and the ISPE Foundation mourn the loss of a beloved member, mentor, and leader.
Building off the success of the 2023 ISPE Annual Meeting & Expo, the program committee has developed a robust workshop program, taking place Sunday, 13 October, which is based on the practical application of the ISPE Baseline Guide and ISPE Good Practice Guide (GPG) Series, covering the following key areas:
Novel therapies refer to innovative and often groundbreaking approaches to treating medical conditions. These therapies typically involve new modalities aiming to improve upon existing treatments or to provide entirely new options for patients. The development of novel therapies is not immune to the challenges of standard therapeutic pursuits; however, the use of automation can significantly...
In the bustling city of Boston, amidst the vibrant biotech community, the 2024 ISPE Biotechnology Conference will gather industry leaders and innovators for a pivotal set of discussions on Track 4: Lifecycle...
The ISPE Advancing Pharmaceutical Quality (APQ) program team has been actively engaged with the US Food and Drug Administration’s (US FDA) Quality Management Maturity (QMM) program since its inception and along the...
