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.

Preparation and in vitro Dissolution Behavior Investigation of Frovatriptan Succinate Film-coated Tablet / 中国药房

OBJECTIVE:To prepare Frovatriptan succinate film-coated tablet,and investigate its in vitro dissolution behavior. METHODS:Using lactose monohydrate,microcrystalline cellulose,dioxide,silica,sodium carboxymethyl starch and magnesium stearate as accessories,Frovatriptan succinate tablet was prepared. Using opadry premix spray-coating liquid,Frovatriptan succinate film-coated tablet was prepared. Single factor test was used,using moisture,angle of repose,rigidity,friability,disintegration time and dissolution rate as indexes,to screen the formulation;using dissolution degree as index,coating material dosage was screened. The dissolution curves in vitro of self-made tablets and imported tablets in water,0.1 mol/L HCL,pH of 5.5,6.8 phos-phate buffer solutions were compared. RESULTS:The optimal formulation of Frovatriptan succinate uncoated tablet was as follow as frovatriptan succinate 3.91 mg,lactose monohydrate 99.18 mg,microcrystalline cellulose 33.06 mg,magnesium stearate 1.40 mg,sodium carboxymethyl starch 1.05 mg,silica 1.40 mg;optimal coating weighed quality was 2.0%-4.0%. In the 4 mediums, the dissolution behavior of self-made tablets and imported tablets were similar. CONCLUSIONS:Frovatriptan succinate film-coated tablet is prepared successfully,and its in vitro dissolution behavior is similar to the imported preparations.