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This white paper, first in a series of three, is to help executives and managers assigned to provide due-diligence of prospective contract manufacturing partners a framework in which to make a solid, objective evaluation of its overall operational excellence as it relates to quality.
eBook on meeting USP and EU GDP regulatory requirements. Learn the latest revisions from the U.S. Pharmacopeial Convention (USP) Good Distribution Practices (GDP) according to the European Commission.
This eBook is a resource for best practices for biopharmaceutical process scaleup, as well as technology and analytical method transfer from experts at pharmaceutical manufacturing and engineering companies, while it also highlights the role that DO, ph and conductivity sensors play in ensuring ...
The goal of any cleaning validation program is to reduce the risk of product contamination by minimizing carryover on manufacturing equipment while managing budgets.
This Pharmaceutical Manufacturing eBook shines a light on the full-time value of real-time diagnostic data to help managers understand more deeply the quality and risk management benefits that their connected control devices can bring.
While PCs are required at the higher enterprise and production line levels, at the machine level smart camera vision systems can more cost effectively address ID code reading, text verification, mark quality assessment, label inspection, and general inspection applications.
This eBook includes calibration pitfalls, tools, and best practices for sensing instruments in GxP-compliant environments.
Thermo Scientific CONNECTS™ for the Paperless Lab is a combined methodology, technology and services offering that transforms laboratories into tightly integrated paperless environments.
Why Companies Need Best-of-Breed ERP and EQMS and how PLM fits into the mix
This executive summary from GE Analytical Instruments discusses an advancement in Conductivity analysis technology that can significantly reduce the time spent to comply with the USP <645> regulation.
The FDA mandates the validation of environmental conditions that can affect the strength, identity, safety, quality, and purity of pharmaceuticals, medical devices, or biologics.
Learn how to use GAMP methodology to select and validate a monitoring system software.
To meet important regulatory challenges, it is imperative that manufacturers have a quality management system to manage processes and provide timely access to relevant data, effectively and efficiently.
This white paper takes a look into how an enterprise quality management system (EQMS) can help manufacturers boost product safety by improving data integrity, workflow and communication consistency and regulatory compliance.
Thermo Scientific CONNECTS at GPSG Brazil, Delivering Enterprise-Level Productivity
The pharmaceutical industry has been and continues to be in a steady state of change adjusting to the current regulatory environment, market demands and medical technologies.
This white paper will look at how risk management provides the framework for handling adverse events in a systematic way—from design, to post-market events, to tracking and trending risk across the enterprise.
Vaisala recommends a 9-point process for successfully validating a GDP compliant warehouse or other storage space.
The Best of Pharmaceutical Manufacturing 2013 eBook provides a comprehensive overview of the key challenges faced by manufacturers within the complex pharmaceutical industry landscape.