Whether you are just starting out in the pharmaceutical industry or an industry veteran transitioning into a new compliance or quality assurance role, it’s critically important to understand the fundamentals of regulatory compliance and quality assurance.
Difference between compliance and quality. While the terms are often used interchangeably, there’s a big difference between quality and compliance. Think of quality as the processes, procedures and culture that permeate an organization — enabling it to consistently develop and produce high-quality pharmaceutical products that will meet or exceed regulatory requirements. Quality is everyone’s job, from production floor workers to senior executives. Compliance, on the other hand, is a function that demonstrates and documents the quality of an organization’s processes and products. You can have quality without compliance, but you can’t have compliance without quality.