With companies worldwide failing to get market access due to insufficient stability data the pressure to ensure that the regulatory requirements for stability testing are fulfilled, first time, has never been higher with the pharmaceutical industry as a whole focusing on cutting margins and avoiding recalls.
ICH has created guidelines to regulate the major markets, however the WHO is pushing to amending those guidelines in favor of global harmonization.
Coupled with the trend towards global supply chains and working in climatic zones there are many challenges when it comes to assessing humidity and temperature levels in different supply zones - are you fully prepared for these changes?
Being involved in stability testing, you are well aware that high standards have to be maintained whilst dealing with significant budget and time constraints. Establishing an effective and efficient stability testing programme is key to ensuring regulations are upheld whilst staying within your margins.
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