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Innovations and highlights in the Pharma industry 

Dive deep into the world of Pharma with Zamann’s Expert Blog. Our industry-leading professionals share insights on global project management, quality consultancy, digitalization, and more. Stay updated with trends and innovations transforming the Pharma industry. 

News and more

The Start of Internal Audit in Pharmaceutical Companies

Explore and uncover the key aspects of efficient pharmaceutical internal audit processes, while also delving into the valuable ISO 19011 guidelines. Understand the importance of thorough audit program preparation, as it is essential for achieving success in your auditing efforts
  • Audit and Inspection, Quality Management System
Establishing a robust pharma internal audit program ensures that processes remain efficient, risks are mitigated, and standards such as Good Manufacturing Practices (GMP) are maintained.

Recent Updates in the Regulation of Nitrosamine Impurities

The regulation of nitrosamine impurities has been evolving rapidly due to concerns about their potential health risks, particularly their carcinogenicity. Regulatory authorities worldwide, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Therapeutic Goods
  • Nitrosamine
Pharmacy shopping and drug abuse

Artwork Change Control Management in the Pharma Industry

Managing artwork change control in pharma requires rigorous procedures, documentation, and regulatory adherence. This guide covers a step-by-step process, includes a practical checklist and table, and offers expert insights for seamless pharmaceutical packaging artwork updates.
  • Change Management, Quality Management System
Artwork change control ensures that any modifications to packaging elements are executed in a controlled, documented, and compliant manner.

How to predict for the formation of NDSRIs ?

The detection of N-nitrosamine impurities in medicines and the increasing presence of nitrosamine drug substance-related impurities (NDSRIs) have presented significant challenges for both drug manufacturers and regulatory agencies.
  • Blog, Nitrosamine
Female pharmacist staring at packaged pharmaceutical drugs in her hands

Reprocess and Rework in Pharma: A Comprehensive Guide

This comprehensive guide on reprocess and rework in pharma explains their definitions, highlights key differences, and offers practical tips for successful implementation. Stay compliant and maintain product integrity with our expert insights.
  • Change Management, Quality Management System
Implementing effective reprocess and rework strategies is essential for maintaining compliance and ensuring product quality.

How to Effectively Manage Facility Change Control in 8 Steps

Managing facility change control is crucial for maintaining compliance, ensuring safety, and optimizing operational efficiency. This guide covers a structured approach, best practices, and a checklist to streamline facility change management.
  • Change Management, Quality Management System, Validation and Qualification
A structured facility change control process ensures changes are well-documented, assessed, and implemented with minimal disruption.

How to Manage Equipment Change Control?

Managing equipment change control is crucial for maintaining operational efficiency and compliance. This guide provides a step-by-step approach to equipment change management, including key considerations, risk assessments, and a handy checklist.
  • Change Management, Equipment Qualification, Quality Management System
Managing equipment change control effectively ensures operational efficiency, safety, and compliance.

How to Manage Scale-Down Change Control?

Scale-down change control is a crucial process in pharmaceutical manufacturing. This guide provides a step-by-step approach, covering risk management, regulatory compliance, and a checklist to streamline implementation.
  • Change Management, Quality Management System
Effective risk management is crucial when implementing scale-down changes.