ISPE

OCTOBER 28, 2022

Before the COVID-19 pandemic, it was unthinkable for a system integrator to suggest remotely conducting an acceptance test for an automation project. Before the COVID-19 pandemic, acceptance testing of automation projects was conducted in person, with multiple subject matter experts attending. is used as a guide.

Communication 52

Communication Documentation FDA 52

ISPE

MAY 9, 2023

Firmino 1 May 2023 The global pandemic has demonstrated that now, more than ever, we need to work toward a global solution and prioritize the harmonization of technical requirements. Positive improvements have been observed in the acceptance and implementation of international standards by various regulatory agencies in Latin America.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 6, 2023

This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach to risk management can help CM achieve its full potential. billion US in 2021 to $1.9 billion US in 2021 to $1.9

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

SEPTEMBER 8, 2023

This ISPE team developed a comprehensive survey, with the objective of gathering data on the specific origins, extent, and magnitude of the challenges and barriers that limit or reduce the development and implementation of innovative technologies. The survey launched in April 2023 and is still open !

FDA 52

FDA Dosage Documentation Communication 52

ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. In an attempt to address these challenges, in 2019 the ICH endorsed ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (and Annexes).

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

AUGUST 30, 2022

With ever-increasing supply chain challenges, raw material shortages have become a point of discussion. In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Similarly, an increased demand forecast could lead to a raw material shortage.

Documentation 52

Documentation FDA Packaging Communication 52