Application of statistical process control for spotting compliance to good pharmaceutical practice

ABSTRACT For the release of pharmaceutical products into the drug market; most of the pharmaceutical companies depend on acceptance criteria - that are set internally, regulatory and/or pharmacopeially. However, statistical process control monitoring is underestimated in most quality control in cases; although it is important not only for process stability and efficiency assessment but also for compliance with all appropriate pharmaceutical practices such as good manufacturing practice and good laboratory practice, known collectively as GXP. The current work aims to investigate two tablet inspection characteristics monitored during in-process control viz. tablet average weight and hardness. Both properties were assessed during the compression phase of the tablet and before the coating stage. Data gathering was performed by the Quality Assurance Team and processed by Commercial Statistical Software packages. Screening of collected results of 31 batches of an antibacterial tablet - based on Fluoroquinolone -showed that all the tested lots met the release specifications, although the process mean has been unstable which could be strongly evident in the variable control chart. Accordingly, the two inspected processes were not in the state of control and require strong actions to correct for the non-compliance to GXP. What is not controlled cannot be predicted in the future and thus the capability analysis would be of no value except to show the process capability retrospectively only. Setting the rules for the application of Statistical Process Control (SPC) should be mandated by Regulatory Agencies.

Dissertation document collection capability analysis of graduate students in one University Affiliated Hospital / 中华医学科研管理杂志

Objective Take a particular Affiliated Hospital of Xinjiang Medical University as an example,collecting data on dissertation document collection of master students graduated in recent five years for comprehensive analysis,to provide empirical evidence for enhancing the research capacity of future graduate students.Methods Review master dissertations during 2011-2015 of this hospital,collecting citation data of references on both Chinese and foreign language literatures to conduct de scriptive analysis.Results The total average literature citation of master dissertations increased 4.18 ％ during the period of 2011-2015.This five-year data shows negative growth of Chinese literature citation,while foreign literature references increased.Conclusions Both Chinese and foreign journals are dispensable resources for graduate student completing their dissertations.However,more improvement and tailored guidance needed,for example,enhancing the professor tutoring of literature searching capacities,make good use of university library resources,as well as improve foreign language skills of graduate student,all these measures are important for empowering the research capacity of university graduate student,particularly for literature searching and citation.