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 or GxP) 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 Venn QA department incorporating both early and late phase, 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 team perform GAP analyses and audits to assess the robustness and effectiveness of Venn’s internal quality management system as well as our sponsors quality management system.
In addition, we can support you with the following activities:
- Implementation of (parts of) Quality Management Systems, Document Management Systems, Archiving, Computer System Life Cycle
- Audit/QC check non-clinical and clinical studies
- GxP Training
- Conduct of Audits:
- Study Compliance Audits (Non-clinical & Clinical)
- Vendor Audits
- Computer System Validation Audits
- Mock Inspections