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9 q&more articles about the topic quality assurancerss
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Metrological traceability: central concept of metrology and requirement of accreditation standards worldwide
Metrological traceability is necessary for consistent, comparable and valid measurement values. As a fundamental concept of modern-day metrology, it allows measurement results to be internationally recognized and is required by norms and accreditation standards all over the world. The ...
Requirements for smart laboratory instruments and interconnected systems in the modular lab of the future
Laboratories tend to be central hubs for chemical, biotechnological, pharmaceutical or foodstuff production. They play a key role in research and development, chemical analysis, quality assurance, maintenance and process control.
Minimum Weight and Routine Testing According General Chapters 41 and 1251
Weighing is one of the key activities carried out in every QC laboratory. Usually, it is one of the first parts of a whole analysis chain. As any weighing errors have the potential to propagate through the whole analysis and deliver an inaccurate final result, the United States Pharmacopeia (USP) ...
A value stream analysis reveals worthwhile starting points for implementing lean laboratory processes
The process industry is seeing manufacturing structures change, production chains becoming global and higher requirements placed on manufacturing processes. Businesses need to adapt to declining sales volumes and the demand for more specific product characteristics.
Continuous manufacturing in the pharmaceutical industry
The question should not be why is the pharmaceutical industry beginning to engage in continuous manufacturing (CM), but rather “what took so long?” Essentially every other industry has been producing materials continuously for decades. Henry Ford began using the assembly line on December 1st, ...
Paths to global competence standards
Quality assurance in medical laboratories is of fundamental importance for the process of in vitro diagnosis for many diseases. The ISO 15189 standard ("Medical laboratories — Particular requirements for quality and competence") was developed to address the general dissatisfaction with current ...
Practical application of GMP analysis of pharmaceutical active ingredients and drugs
Today, the guidelines of „Good Manufacturing Practice“ (GMP) are the basis for any production and marketing of active pharmaceutical ingredients (APIs) and drugs. Comprehensive quality management systems document and control the production processes and environment and not least the analytical ...
U.S. Pharmacopeia Convention (USP) defines changes to balances testing procedures
The U.S. Pharmacopoeia Convention (USP) has recently published a revised version of its mandatory chapter 41 (Balances) plus amendments to chapter 1251 (Weighing on an Analytical Balance). Effective 1 December 2013, the revised chapters mean pharmaceutical companies are now facing the problem of ...
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The q&more concept is to increase the visibility of recent research and innovative solutions, and support the exchange of knowledge. In the broad spectrum of subjects covered, the focus is on achieving maximum quality in highly innovative sectors. As a modern knowledge platform, q&more offers market participants one-of-a-kind networking opportunities. Cutting-edge research is presented by authors of international repute. Attractively presented in a high-quality context, and published in German and English, the original articles introduce new concepts and highlight unconventional solution strategies.
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