How Do You Set Up A Quality Pharma Organization?

In order to set up a quality organization, the organization must have a culture of quality. Survey findings in the Forbes Insights-ASQ white paper published in fall of 2014 offer research findings which help illuminate what quality culture means to organizations globally.

Start At The Very Root Of Quality Standards and Good Practices

Additionally, in the pharmaceutical industry, FDA regulations set the minimum standards for quality in order to ensure products are safe, pure and effective. These good manufacturing practices are ever evolving with changing technologies, but the roots are established in 21 CFR Parts 210 & 211 (for drugs). FDA has recently began looking at quality metrics as well, and even established an Office of New Drug Quality Assessment (ONDQA) which assesses the critical quality attributes and manufacturing processes of new drugs, establishes quality standards to assure safety and efficacy, and facilitates new drug development.

ONDQA focuses on critical pharmaceutical quality attributes (chemistry, pharmaceutical formulation, stability, manufacturing processes, bioavailability, and product performance) and on their relevance to safety and efficacy. ONDQA emphasizes quality by design in the evaluation of critical aspects of pharmaceutical quality; has a strong focus on manufacturing science; integrates review and inspection functions; and uses modern statistical methodologies. Further to FDA, there are global organizations which establish guidelines for quality as well, such as ISO, ICH, ISPE, WHO, and others.

Use These Four Pillars To Build Your Quality Foundation