ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published 15 November 2021. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.”

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published 15 November 2021. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.”

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 7, 2023

This article reviews two case studies that cover sustainable pack types and extension of shelf life. Case Study One: Packaging Materials The first case study looks at developing more sustainable packaging materials and reducing the size of packaging materials. Let’s use the example of the packaging for medicines.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 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 In 2021, CONTINUUS Pharmaceuticals secured a$69.3

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

AUGUST 30, 2022

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). Finally, the DP is packaged in a suitable container to ensure continued quality. This is followed by DP manufacturing, where the DS is formulated with excipients.

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Documentation FDA Packaging Communication 52

ISPE

MARCH 7, 2023

This article explores effective management and oversight processes for accelerated delivery of large-scale programs of work. 10 May 2021. We hope this article inspires the following considerations: Has my company set the right level of ambition to help combat climate change? October 2021. Gerber, and K. April 2016.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

ISPE

MARCH 15, 2023

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). 14–25 (November–December 2021). HowToRobot.

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ISPE

SEPTEMBER 10, 2023

In this article, we describe the assessment of lag time for global regulatory approvals of postapproval CMC changes for multiple products over a three-year period. Published 2021. IPRP Strategic Vision 2018–2021. Bolivia, Hong Kong, Malaysia, Philippines, and Vietnam). WHO Technical Report Series, No. Accessed 14 June 2023.

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