Remove pharmaceutical-engineering section special-reports
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ISPE Briefs: New Guide Promotes Cultural Excellence

ISPE

ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Cultural Excellence provides a quality management framework for assessing and advancing an organization’s culture of quality. Excellence in organizational culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes.

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ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma

ISPE

In sections where we applied ChatGPT for example cases, we indicate this as such: The question or remark from us is labeled as Authors. Second, ChatGPT provides a very broad, high-level overview of possible activities and tasks for which it may be used in the pharmaceutical industry. Specific aspects of pharmaceutical roles (e.g.,

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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

Section 361: Adulterated Cosmetics. Because there are products with active pharmaceutical ingredients (APIs) in the families (FDA-regulated topical drug products), the grouping strategy helps in the later stages of this work’s validation phase. Cleaning Engineering and Equipment Design.” Pharmaceutical Technology (April 1993).

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Herein, DM refers to a manufacturing model in which many units or facilities are disseminated across different geographical areas 6 , 7 DM facilities may produce similar or identical products under a unified pharmaceutical quality system (PQS) or operate as independent units with different outputs.

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CMC Requirements for New Drug Registration in Latin America

ISPE

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements. 6, and 2.3.S.7 7 are required.

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Agile, Data-Driven Life Cycle Management for Continuous Manufacturing

ISPE

In recent years, global pharmaceutical supply chains, still based on traditional batch- and intermediates-based manufacturing, were overwhelmed by their own vulnerabilities and inefficiencies, and were stressed to the brink of failure as a result of the SARS-COV-2 pandemic. In 2021, CONTINUUS Pharmaceuticals secured a$69.3

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New EU AI Regulation and GAMP® 5

ISPE

The document is based on a number of reports from the EU Commission and aims to ensure citizens’ trust in AI systems. Main section chapter 7.12 Main section chapter 7.12 The pharmaceutical industry is increasingly relying on such innovative technologies to automate many functions previously performed by humans.