RPI has deep Quality expertise in all areas of GxPs. We assist clients with vendor selection and audit, review and management of quality agreements and have first-hand experience with the design, construction and validation of manufacturing facilities. We have considerable experience leading sponsor inspections by health authorities in the US and Europe, including mock audit preparation. Clinical Quality expertise includes establishment and maintenance of GCP compliance programs for all phases of drug development and extensive experience with GCP compliance audits of clinical sites, clinical laboratories, drug safety databases, data management centers and CROs.
Core Competencies:
- Quality Document
- SOPs, documents systems
- Quality Assurance
- Document review, drug release, audits
- Quality Control
- In process controls, validation
- Quality Issue Management
- Investigations, deviations, OOS, CAPAS
Commonly Requested Services:
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- Prepare/revise corporate SOPs appropriate to the stage of product development
- Conduct GxP audits
- Establish Quality Agreements Provide QA review/approval of master/executed batch records, specifications, test methods, validation and stability protocols and reports
- QA release of products materials
- PAI readiness training
- Mock audits
