White papers are sponsored content and is the sole responsibility of the authors and is not endorsed, reviewed, nor a published article of Pharmaceutical Engineering® magazine or ISPE.
In today’s rapidly evolving landscape of manufacturing and quality assurance, the need for efficient, accurate, and compliant process validation has never been more critical. This guide will explore the evolution of process validation, the challenges and opportunities it presents, and the benefits of adopting a fully digital process-centric and data-driven approach. You will learn how to...
Temperature mapping is vital for preserving GxP product quality during manufacturing, storage, and distribution, especially for frozen products. Warehouses pose unique challenges for temperature mapping due to their size, study duration, and seasonal variations. However, the principles for temperature mapping remain consistent, whether for warehouses, chambers, refrigerators, or freezers.
Your Comprehensive Guide to Navigating the New USP <797> and <800> Standards. The pharmaceutical landscape is evolving, and with it comes a set of refined standards that will impact every aspect of compounding. This white paper offers a detailed analysis to understand these changes easily and quickly. Learn about the nuanced CSP categorizations, enhanced room pressure monitoring,...
In the pharmaceutical industry, the demand for aseptic flexible multiformat production lines has increased due to the need for small batches, diverse product portfolios, and compliance with stringent regulatory requirements, including the new Annex 1 of Good Manufacturing Practices (GMP).
