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NEW - GMP/GDP audit simulations
News, published: 02.05.2012.
There are thousunds of GMP/GDP audits conducted worldwide every day. Yet, each and every audit is very stressful for all involved employees. Furthermore, the audit always brings some tension for the company. So, why GMP/GDP audit...
PharmaSupport - simple solutions
PharmaSupport, published: 28.03.2012.
PharmaSupport is a new concept of an overall GMP support to pharmaceutical industry in areas of quality management, production, quality control, development, storage/distribution and suppliers management. The idea of a whole...
Cold chain management
News, published: 17.01.2012.
Cold chain is today without any doubt one of hot topics in storage and distribution of medicinal products. It is not enough any more to have refrigerated storage area and air-conditioned vehicle. Many other things are required to...
Contract manufacture and QP role
Regulatory news, published: 14.12.2011.
Pharmaceutical industry is now more than ever based on contract manufacture. This also implies new challenges for QP who often has to certify the batch manufactured in other side of the world, at the site usually not under...
Contract GMP auditing
News, published: 27.10.2011.
These days, when so many activities in pharma business are outsourced, GMP audits are of paramount importance for any pharmaceuticl company, but are also expected by competent authorities. However, at the same time the audits are...
Improve your QP competences
News, published: 20.07.2011.
Batch release decision relies on complex expert, legal and ethical aspects that at the end of the day should be faced with the sales forecasts and market expectations, so it is of paramount importance for any pharmaceutical...
New GMP rules for cosmetics in EU
Regulatory news, published: 30.05.2011.
One of the recent EU regulatory requirements is that all cosmetic products have to be manufactured in compliance with GMP rules (Good Manufacturing Practice), applied only in the production of drugs so far. An ideal solution to...
