This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products and related materials and draft guidelines for registration of fixed-dose combination medicinal products.

https://www.who.int/medicines/technical_briefing/tbs/ECSPP_Update_SK_29_Oct_2013.pdf

WHO Expert Committee on specifications for pharmaceutical preparations.

Effects of personalized ventilation interventions on airborne infection risk and transmission between occupants

A utility market transformation project studied energy use and identified energy efficiency opportunities in cleanroom HVAC design and operation for fourteen cleanrooms. This paper presents the results of this work and relevant observations. Cleanroom owners and operators know that cleanrooms are energy intensive but have little information to compare their cleanroom's performance over time, or to others. Direct comparison of energy performance by traditional means, such as watts/ft{sup 2}, is not a good indicator with the wide range of industrial processes and cleanliness levels occurring in cleanrooms. In this project, metrics allow direct comparison of the efficiency of HVAC systems and components. Energy and flow measurements were taken to determine actual HVAC system energy efficiency. The results confirm a wide variation in operating efficiency and they identify other non-energy operating problems. Improvement opportunities were identified at each of the benchmarked facilities. Analysis of the best performing systems and components is summarized, as are areas for additional investigation.

/pdf/cleanroom-energy-benchmarking-results-2xojowqvj0.pdf

Cleanroom Energy Benchmarking Results

This paper summarizes parenteral drug contamination case studies presented at industry conferences and a Food and Drug Administration advisory committee meeting in the period of 2000–2004. CGMP deficiencies associated with each contamination event are discussed. The key role of a well-functioning quality system in contamination prevention is emphasized.

Aseptic processing contamination case studies and the pharmaceutical quality system.

Field validation of a dusting cloth for mycological surveillance of surfaces

Clean rooms and associated controlled environments

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Clean rooms and associated controlled environments