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The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients and active pharmaceutical ingredient (API), as well as the final drug product (see Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically…
In this in-depth focus: Compressed gases - an important component of an environmental monitoring programme; The people factor - contamination of cleanrooms caused by personnel...
In this issue: Miniaturisation of freeze drying equipment, driving excellence in premises and equipment management, a guide to ingredients, and much more...
An effective environmental monitoring programme is designed to estimate the microbial content of the room’s air and surfaces (by incident rate, against alert and action levels, and by assessment of different species) for operations performed within a cleanroom or controlled environment.
New ISPE guidance provides a scientific, risk-based approach for managing cross-contamination risk within shared facilities ...
This scientific poster reviews numerous scientific literature related to microbial survival under a broad range of environmental pressure conditions, and the resilience of microorganisms under variable compression and decompression environments.
A new technical report has clarified best practice on visual inspection for visible particles in parenterals.
The US Food and Drug Administration (FDA) has advised manufacturers of non-sterile, water-based drug products that there have been recent product recalls due to Burkholderia cepacia complex (BCC) contamination.
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate...
11 May 2017 | By Niamh Marriott, Junior Editor
EMA's report focuses on key achievements in the areas of medicine evaluation, support to R&D of new and innovative treatments and safety monitoring...
26 April 2017 | By Particle Measuring Systems
This webinar examined the best way to locate sources of contamination via risk assessment to ensure success through product quality...
21 February 2017 | By Niamh Marriott, Digital Editor
Researchers at MIT have found a new way of using mid-infrared lasers to turn regions of molecules into glowing filaments of electrically charged gas...
21 February 2017 | By Niamh Marriott, Digital Editor
VTT Technical Research Centre of Finland has developed a miniature gas sensor that can be connected to mobile devices.
21 February 2017 | By Niamh Marriott, Digital Editor
A new study has tied the World Trade Centre (WTC) site with paresthesias, a nerve-related issue causing burning or prickling sensations...
20 February 2017 | By Johanna Laiho-Kauranne, Director of Statistics, Luke
Johanna Laiho-Kauranne examines the 17 UN sustainable development goals that have been implemented for monitoring sustainability development...
