Quality in Drug Development
The pharmaceutical industry is one of the most intensely regulated industries. In drug development, regulation is aimed at ensuring the quality, safety and efficacy of human medicinal products. Drug development quality management systems encompass, good practice quality guidelines (GLP, GCP, GMP) and regulations.
The general GxP quality framework aims to ensure quality which is fit-for-purpose and therefore tailored to the specific drug development activity. Consistent quality is achieved with an integrated approach, which combines quality control and independent quality assurance (QA) of products and processes.
The Kinesis Pharma QA department leverages intimate knowledge, experience and expertise to serve the quality requirements of sponsors. These quality requirements may focus on in-house or supplier quality. Our QA consultants are used to performing GAP analyses and audits to assess the state of quality and the actions required to achieve the sponsor’s quality objectives.
- Implementation of (parts of) Quality Management Systems, Document Management Systems, Archiving, Computer System Life Cycle
- GAP analyses, Risk Analyses, Auditing (CRO/CMO/CSO selection, monitoring & regular audits)
- Audit/QC check non-clinical and clinical studies
- Writing and review of Quality Related Documents
- QA Consultancy, Project Management, Outsourcing QA personnel
"Quality is the common denominator of success"
Wendie Hamelink, Ph.D.