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7 q&more articles about the topic quality assurance

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Weighing in the US Pharmacopeia

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) ...

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Reduced lead times for added value in the lab

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.

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Where theory and practice come together

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, ...

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Quality assurance in medical laboratories

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 ...

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More than “keeping a lab notebook”

GLP regulations and their new role in the approval of medicines for advanced therapies (ATMPs)

Before a medicine can be approved for clinical trials, it is subjected to a tightly regulated development process monitored by the relevant bodies.

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Holistic View

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 ...

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New Requirements

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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