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.

Trending Perspective in Quality Control Monitoring and Investigation of Some Properties of Active Pharmaceutical Ingredient

“…The quality of various batches from the Asian manufacturer in a time series 16,17 was assessed by purchasing a pharmaceutically active chemical compound from market retailers and brokers in Egypt. The analysis was carried out and the results were gathered in a pharmaceutical research facility that was involved for a period of two years (from January, 2021 to January, 2023).…”

“…The number of facilities that manufacture chemicals is on the rise, especially in developing countries. Their adherence to good practises in a variety of professions, such as medicine and healthcare, is dubious 17,18 . The quality of the finished product may be predicted using Good Manufacturing Practise (GMP) 19 .…”

Suitability System of Microbiological Method for Nystatin Potency Determination in the Routine Analysis Using Agar Diffusion Method

“…The applied type of the process-behavior chart was Individual-Moving Range (I-MR or XmR) plot. The principle of constructing and interpreting the milestone trending charts has been addressed previously in other works [29][30][31][32]. Equations that are necessary to construct the components of the control charts have been formulated in Excel or charts have been drawn directly through built-in programs.…”