Expert view: Choosing the right CRO: why independence and quality culture matter
Medicines are heavily regulated during development, manufacture and distribution.
To fulfil regulatory requirements, the pharma/biopharma industry is increasingly looking to independent service providers, such as SGS, to deliver comprehensive testing solutions that comply with the requirements of regulators and industry leaders. In this article, we look at some of the hot topics currently influencing development in the pharma/biopharma sector.
THE PILLARS of an effective Quality Management System (QMS) are Quality Assurance (QA) and Quality Control (QC). Regulators want to see a QMS that is both proactive, implements systems and processes that prevent defects (QA) and reactive, using inspections/audits and testing to identify defective products (QC).