Statistical Quality Control Application in Pharmaceutical Manufacturing at Emzor Pharmaceutical Industries

Pharmaceutical manufacturing requires rigorous statistical quality control to ensure product potency, safety, and regulatory compliance, with the application of acceptance sampling plans and process capability analysis central to Nigeria's pharmaceutical industry quality management context. This study applies statistical quality control methods to production data at Emzor Pharmaceutical Industries, Lagos State, South West Nigeria, one of Nigeria's leading pharmaceutical manufacturers. Tablet weight, hardness, disintegration time, and active ingredient assay data were analysed for three product lines over six months. Acceptance sampling plans were designed using MIL-STD-1916 and Operating Characteristic curves. Xbar-S control charts monitored process stability. Process capability indices (Cp, Cpk, Cpm) were computed for each quality characteristic. All three product lines achieved acceptable control chart stability after eliminating three special cause incidents identified during the study. Active ingredient assay showed Cpk of 1.41, meeting the pharmaceutical benchmark of 1.33 or above. Tablet weight showed Cpk of 1.19, indicating marginal capability requiring process attention. Acceptance sampling OC curve analysis revealed that current sampling plans had 18 percent probability of accepting lots with 5 percent defective proportion. Revised sampling plans reduced this acceptance probability to below 3 percent. The study provides Emzor's quality assurance department with enhanced statistical monitoring protocols and recommends automated in-process control systems for tablet weight monitoring and strengthened incoming raw material sampling. Keywords: statistical quality control, pharmaceutical manufacturing, process capability, Emzor, acceptance sampling