Statistical process control of manufacturing tablets for antiretroviral therapy

In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical control (SPC) tools. These medicines are manufactured by Fundação para o Remédio Popular “Chopin Tavares de Lima” (FURP) laboratory, distributed free charge to patients infected with HIV Ministry Health DST/AIDS national program. Data 529 batches from 2012 2015 were collected. The critical quality attributes weight variation, uniformity dosage units, dissolution evaluated. Process stability assessed charts, capability indices Cp, Cpk, Pp, Ppk (process capability; adjusted for non-centered distribution; potential or global process; distribution, 3TC data 2013 revealed a lack consistency compared other years, showing Cpk lower than 1.0 chance failure 2,483 in 1,000,000 tablets. Dissolution showed improvement, equal 2.19 1.99, respectively. Overall, charts variability special causes. Additionally, it possible point out opportunities changes, which fundamental understanding supporting continuous improvement environment.