QA and QC
News
Vaisala organises seminar on mapping and monitoring in GMP environments – 8-May-2013
Free event in Birmingham is aimed at professionals involved in measuring or monitoring in regulated life science environments
Opinion: The price of quality– 28-Mar-2013
Quality is taken for granted - until it fails
Intertek expands GMP Quality Control pharmaceutical microbiology services– 4-Mar-2013
Able to perform ID of bacterial cultures using Biolog MicroStation Identification System
Opinion: Digesting the DNA results– 29-Jan-2013
The discovery of horse DNA in beefburgers could lead to more stringent checks on the food industry
PHSS to present special award to John Sharp– 28-Sep-2012
His short guide to GMP to be distributed to UK pharmacies by Bioquell
Cherwell Laboratories supports NHS Quality Assurance training– 5-Sep-2012
Specialist products on show at NHS Pharmaceutical QA Symposium for Technical Services, 25–26 September
ICCCS announces congress schedule– 17-Jul-2012
The 21st International Symposium of the ICCCS is being held in Switzerland from 3-7 September, 2012
In‐process pharma metal detection system secures API integrity– 6-Jul-2012
Enables reduction of product waste and manufacturing downtime earlier in the production process
Bosch to show liquid and solid pharma developments at ACHEMA 2012– 27-Apr-2012
All-in-one solution for the production of solid pharmaceuticals is available for small batch sizes and laboratory usage as well as for large batch production environments
Waldmann's Tevisio magnifier supports the most demanding visual tasks – 20-Feb-2012
LED magnifier luminaire offers exceptional flexibility through innovative mounting technology as well as high visual quality
Sanyo dual-cooling freezer provides sample security– 30-Jun-2011
The upright 728l model is ideal for valuable research or clinical samples
New scanner means the sky's the limit– 28-Jun-2011
Powerful analytical instrument gives much more detailed information about the inside of a sample than microscopy techniques
Articles
How to prevent drug shortages yet sustain quality– 25-Mar-2013
The US FDA reported that 251 drugs went into shortage during 2011, of which 73% were sterile injectables. The shortages followed a common pattern: one or more manufacturers temporarily stopped production to address a manufacturing quality problem, most often caused by microbial or particulate contamination. Sterility assurance, especially in facilities that are not fully automated, can be difficult to accomplish, but at the heart of the drug shortage problem is the inability of the market to observe, and therefore, to reward quality
Making the grade in filters– 3-Dec-2012
The removal of micro-organisms from fluids by passage through filters is a very complex process and is dependent on interactions relating to the chemistry and surface characteristics of the membrane, the micro-organisms, and the suspending fluid. The selection of a membrane filter for a particular product or process is an important choice and one that requires an assessment of the filter, the chemical nature of the product and the physical demands that will be placed on the filter.
Particulates in parenterals– 3-Dec-2012
Particulate matter is a key indicator of quality for injectable drug products. Test methods are being improved with the intent to find the materials responsible for the particle(s). The desired goal of zero defects is not a workable acceptance criterion for visible particulate matter because of current packaging components and processing capabilities. The value of vision inspection systems for elastomeric primary components is shown to mitigate the risk of particulates in finished parenteral drug products.
QbD and risk management through HVP technology– 30-Oct-2012
The increasing development of biopharmaceuticals with active properties that would be destroyed by terminal sterilisation means that the requirements for aseptic processing have grown. Traditional manual approaches to sterilisation using detergent sprays are unable to reliably achieve the required reduction in bioburden levels. Hydrogen peroxide vapour (HPV) sterilisation can safely provide a validated 6-log sporicidal reduction in bioburden within a contained environment, be that an isolator, transfer chamber or a room.
Paperless automated monitoring– 23-Mar-2011
When looking to expand its drug manufacturing operation in New Jersey, ImClone Systems Inc recognised that eliminating paper-based record keeping was the key to improving the efficiency of its environmental monitoring and QC programme
Events
Water systems: Principles in Practice– 29-Oct-2012
15 - 17 October 2013
Three-day course
Barnard Castle, UK