Quality Assurance Articles

An extended survey was conducted o­n the topic of clinical quality assurance (CQA) benchmarking in pharmaceutical companies to gather new data.


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When building a biotech manufacturing facility and a QC lab, which scenario do you choose — build manufacturing first, build the QC lab first, or build both facilities simultaneously?

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GMP is the acronym for Good Manufacturing Practice. The GMPs represent a set of regulations that were promulgated as a final rule by FDA in 1978 and intended to ensure the safety and efficacy of the nation's drug products. The GMPs, as we know them today, are the result of over a century of actions by industry and reactions by government and consumer groups to bring guidance and controls to the food and drug industry, resulting in a safe supply of food and medicines.

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EPA can now hold industry's environmental toes to the test of "any credible evidence" (ACE), as opposed to procedures found in the Code of Federal Regulations. And industry doesn't seem to like it  There is an old proverb that states "...be careful what you wish for, you might get it." In complying with new air quality regulations, industry may find itself reflecting on that old chestnut. Historically, EPA told industry exactly what to monitor and when to monitor for drinking water, wastewater, air, and so forth. Now, at least for air, these edicts from EPA are changing. Instead of imposing monitoring requirements on industry, EPA is allowing industry to tell the agency what each plant will monitor and how such monitoring will ensure that a given plant site is operating within its allowable limits.

“GMP in R&D Working Group” members of the APIC (CEFIC)

The author describes the efforts of the standards committees to establish guidelines for Process analytical technology (PAT) implementation and the impact of the guidelines o­n the industry.

According to the EU Guide to Good Manufacturing Practice (GMP) the manufacture of sterile products is subject to special requirements to minimize the risks of microbial contamination and of particulate and pyrogen contamination. To control the particulate and microbiological cleanliness, the processing areas should be monitored with special attention paid to air, surfaces and personnel. The aim of this study was the evaluation of the environmental cleanliness in the CIVA preparation area for non-cytotoxic products in a hospital pharmacy department, and to compare the results with the limits set by the EU GMP Guide. Particle counter, volumetric air sampler, and settle plates were used to determine the microbiological air quality. Ten samples were taken at multiple locations under ‘in operation’ and ‘at rest’ conditions. In the critical area, settle plates were exposed to control the aseptic processes. Surfaces and personnel (glove prints) were tested with contact plates.

FDA and manufacturers seek to curb drug counterfeiting while legislators consider liberalizing drug importing policies to cut pharmaceutical costs.

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EFPIA / CEFIC Working Group

FDA is re-engineering the CMC review process for innovator and generic drugs and backing risk-based ICH quality standards.

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