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Category: GxP

The revised EU GMP Annex 1 modernizes sterile manufacturing with technology and a risk-based approach, improving product quality and patient safety.
GMP

EU GMP Annex 1: Your Guide to Contamination Control

Explore the essential distinctions that exist between the previous version and the most recent updates of the EU GMP Annex 1 guidelines. Understand how these changes play a critical role in shaping the practices of sterile pharmaceutical manufacturing. Additionally, examine how the latest revisions affect compliance requirements within the industry, highlighting the implications for manufacturers aiming to adhere to the updated standards and maintain high quality in their production processes.

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Trucks in the distribution hub
GDP

Guide to Good Distribution Practices and GDP Certification

Good distribution practices ensure maintaining product safety and quality during distribution across the supply chain and this practice is of significant importance for the pharmaceutical industry. Good Distribution Practices (GDP) Compliance report for Pharmaceutical Industry demonstrates Quality commitment & sound practices in the entire pharmaceutical distribution supply chain.

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GMP

Top 10 Steps for Qualifying a New GMP Facility

The qualification of a GMP facility is essential to ensure the high standards of pharmaceutical production and to guarantee product quality. In our latest article, you will learn the 10 most important steps for the successful qualification of a new GMP facility to effectively support compliance with regulatory requirements.

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Environmental monitoring software, helps pharma facilities reach maximum productivity.
GMP

How Digitalization Drives Pharma Monitoring Success

The pharmaceutical industry faces numerous challenges in environmental monitoring. This blog explores best practices for digital solutions, change management, user acceptance, and innovative disinfection methods, offering valuable insights for industry professionals.

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AI and new technologies in enhancing high compliance in environmental monitoring control and plan
GMP

How Smart Monitoring Solutions Benefit the Pharma Industry

Uncover the transformative impact of smart monitoring solutions on the pharmaceutical industry, optimizing operations and driving efficiency. Explore the essential role of environmental monitoring in upholding quality standards and regulatory compliance within pharmaceutical manufacturing processes.

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