Current Issue : October-December Volume : 2014 Issue Number : 4 Articles : 3 Articles
Stability means the time during which the drug product remain in its same property and characters. Stability study necessary during the decomposition of active drug, toxic product may be formed. In manufacturing, good formulation will taken long time for decomposition. Drug degradation has studied individually but it time consuming. In accelerated stability testing to predict the shelf life of a product by accelerating the rate of decomposition, preferably by testing the temperature of reaction condition. In this rapid detection in the formulation prediction of shelf life, protect reputation of producer, established storage condition. There are different stages of drug development during stability study. Some basic principle of stability testing follow during testing of product i.e. selection of batches and samples, testing criteria, analytical procedure, specification, storage condition, number of batches, packaging material, evaluation, testing frequency, storage period, stability information....
Six sigma is a statistical concept which helps us to define the problems systematically, provides tools to measure and analyze the influential factors, identifies the improvements that can be implemented easily and ensure that the changes which have been made, are kept alive through a control process and maintains the gains over the time. It is a known fact that in a process with six sigma capability, process variation is not reduces more than 3.4 defects per million opportunities. There are two six-sigma sub methods namely DMAIC and DMADV. The pharmaceutical industry and healthcare sector is the most regulated compared to other sectors. Lean and six sigma are the two best continuous improvement methodologies which originated and widely used to implement in manufacturing industry. Recently, the healthcare sector has slowly adopted both lean and six sigma in order to eliminating medical errors and improving patient safety. Lean can provide value by reducing delays, while Six Sigma can provide value by reducing defects and deviation in healthcare processes. The implementation of Lean and Six Sigma in healthcare sector is relatively new topic and very little research has been performed in this area. Thus this research aims to study the supply chain related to drugs or pharmaceutical products and provide a modified framework using lean and six sigma methodologies to figure out the effect of complexity as well as improve patient safety and supply chain efficiency in healthcare....
The importance of applying statistical techniques in all stages of product development and also in every stage of process is of greater importance not only to meet product quality but also to meet regulatory requirements and ensuring compliances with continuous quality Improvement. By applying these statistical tools in every stage of product one can ensure a high level of confidence on product as well as process. Construction, Applications, importance, of certain statistical tools like design of experiments (DOE), histograms, control charts, pareto charts and process capability analysis are described in this review which can be used at various levels of pharmaceutical product manufacturing like DOE during product development, process capability during validations. Control charts to monitor process over time, histograms to understand process. By the application of these techniques can establish statistical confidence on the process, which gives an in depth understanding of the process thus it also paves way to identify problems there by able to establish controls, by selecting appropriate tool can reach process robustness thus is capable of better understand the processes in order to improve them and to eliminate batch and product failures....
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