Statistical Process Control as a Tool to Control Weight Uniformity of Tablets

HETAL PATEL1*, CHIRAG DESAI2, ANIL THAKER2

1Department of Pharmaceutics, Maliba Pharmacy College, Bardoli Mahuva Road, Tarsadi, Surat, Gujarat, India

2School of Pharmacy & Technology Management, SVKM’s NMIMS University, Vile Parle (W), Mumbai, Maharashtra, India

QC 33

ABSTRACT

Quality of a product can be controlled at two distinct phases of manufacturing process: Post-process control and In-process control. Post process control is a postmortem study and leaves no scope for improvement as the entire batch has been produced; whereas in-process control provides surveillance and feedback for keeping processes in control and hence provides scope for improvement.

Aim of the present work was to apply statistical control tool such as control charts and frequency distribution curve to weight variation of tablets which is the main In Process Quality Control (IPQC) variable affecting the dosage variation.

Limitations of Pharmacopoeial specifications for weight variation test and current practice in industries which needs reference have been highlighted.  Cipium tablets were prepared by wet granulation method. The tablets were collected from both the sides of double rotary compression machine in small groups in the order of compression and weighed individually at every half an hour.

Pharmacopoeial compliance for weight variation was checked and Mean, Range and SD charts were plotted which were used to check the state of the process.

Inspection of the control charts indicated that some disruption of uniformity occurred during the compression but Pharmacopoeial compliance was observed. 

Keywords: 

Statistical Process Control (SPC), Control charts, Frequency Distribution Curve (FDC)