It takes more than Quality by Design (QbD), fostering a culture of quality and measuring quality to meet the drug packaging standards that 21st century pharmaceutical and biopharmaceutical companies demand. It takes all three —working in harmony — facilitated by the best available technology.
What do they demand? Zero defects, which is a manufacturing principle that some industries have attempted to adopt at various times during the last seven decades (its peak, perhaps, coming with the Six Sigma philosophy of the 1980s and 1990s). Although some companies remain true to Six Sigma, others have moved on to other quality programmes.
Whatever a manufacturing company calls it, the principle remains the same: achieving as close to zero defects as possible by the continuous improvement of processes. It involves machine operators, operator training programmes and the automation of inspection processes — along with a strong, quality focused culture — to achieve the highest possible quality standards.
Most industries strive to live up to this principle, but it’s especially crucial in the pharmaceutical industry, wherein potential product defects can cause direct harm to patients, many of them living with chronic disease diagnoses and a subset who have multiple comorbidities. In addition to leveraging the latest technologies, remaining mindful of the end user and their challenges is an essential part of establishing a culture of quality and achieving zero defects.
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