ISPE

SEPTEMBER 11, 2023

Cauchon, PhD 1 September 2023 The biopharmaceutical industry must develop and implement innovative ways of working to be effective and efficient in the current healthcare ecosystem, in which high-quality medicines, adaptability, and assurance of supply are of critical importance.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 29, 2023

This structure does not allow explanation of justification for the control strategy, 2 particularly when a quality by design (QbD) approach is employed. 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.”

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

This structure does not allow explanation of justification for the control strategy, 2 particularly when a quality by design (QbD) approach is employed. 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.”

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 8, 2023

It is incumbent for industry to modernize manufacturing processes to improve efficiency and increase confidence in quality assurance for the benefit of patients while introducing novel technology and modalities as the science advances. Representatives from regulatory authorities are also encouraged to complete the survey.

FDA 52

FDA Dosage Documentation Communication 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. And beyond that, they should willingly improve regulatory frameworks to streamline processes and global harmonized requirements (e.g.,

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 7, 2023

For decades, the pharmaceutical industry has worked to transform the lives of patients by researching, developing, and manufacturing medicines for a wide variety of common and rare diseases, something that will continue for many years to come. Global regulators are assessing drug products for quality, efficacy, and safety.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

JANUARY 8, 2023

Towards Explainable Artificial Intelligence.” In this article, we elaborate on the benefits and requirements on xAI from a GxP point of view, along with the development and production process, with a focus on strategies to ensure that the intention of use is met and to manage risks for safety that arise from xAI itself. 1 Samek, W.,

Communication 52

Communication Documentation FDA 52