Chemical stability of pharmaceutical molecules is most important as it has impact on the safety and efficacy of the drug products. Stress testing or forced degradation is an analytical tool to study the behaviour of the products as well as to understand the resolving power of the analytical method used. Stress testing reveals the quality of pharmaceutical products exposed over the time period as well as different environmental conditions viz., heat, hydrolysis, oxidation, photolytic etc. ICH guideline defines stress testing as: Studies undertaken to elucidate the intrinsic stability of the drug substance. Such testing is part of the development strategy and is normally carried out under more severe conditions than those used for accelerated testing. Stress studies provides more valuable information about the degradation impurities, called as degradants, which are likely to form during the shelf life of the product lifecycle in a very short period compared to...
Data integrity is one of the most talked in the pharmaceutical industries in the recent past as regulators have issued multiple FDA Warning Letters and EU GMP Noncompliance Reports about the failures of integrity of key electronic records. Good practices like documentation, record keeping and data integrity are the essential components of the quality system in a GMP environment to protect and ensure the quality of the product and hence safety of the patient. FDA has focused intensely on data integrity issues since 2010 and issued many warning letters to pharmaceutical companies related to poor electronic data integrity. The warning letters issued to drug manufacturers related to data integrity were 2 in 2010, 8 in 2013, 12 in 2014, 13 in 2015, 16 in 2016 etc and is increasing continuously. The deficiencies found in recent cases of electronic data integrity are 1. Disabling of software audit trail functions 2. Inadequate user privileg...
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