Internal/External QA Resources and Consultancy
Maintaining Compliance in a Complex Regulatory Landscape
With our global network of quality professionals, we have the experience and expertise to offer you consultancy and support quickly and flexibly. Whether you have one specific ad-hoc question or you need full-time, in-house QA support, we have the resources you need to navigate the complexities of the ever-changing regulatory landscape.
We offer the following services either on an ad-hoc, limited contract or fully insourced basis:
Inspection support
- Inspection readiness assessments
- Inspection preparation (of sites, vendors or sponsor)
- Mock inspections
- On-site inspection support
- Post-inspection follow-up support
QA Services
- Set-up, evaluation or optimisation of CAPA systems
- Surveillance of CAPAs
- Definition of quality metrics
- Issue tracking
- Study- or programme-specific quality plans
- Training
Case Histories - Internal/External QA Resources and Consultancy
GXP Engaged Auditing Services was requested to support a sponsor inspection preparation programme.
- Submission to EMA & FDA for four products within two years were scheduled; all approvals were gained within the planned timelines
- In-house Inspection Preparation Support (1 FTE over 2 years) included gap analyses, development of story boards, inspection readiness evaluation, training, mock interviews, mock inspection, quality evaluation report
- Inspection Preparation Visits were conducted in 2 waves; 1st wave for sites which were likely to be selected for regulatory authority inspections (10-15 sites per product) including check of essential documents, SDV, staff training; 2nd wave for sites which were selected for inspection by regulatory
- Support during inspections (administrative support) if allowed by the inspecting authority (GXP auditors with knowledge of local regulations - and language, if possible) or when authorities preferred to have external staff involved.
- Inspection Preparation Visits at critical vendors (Central Laboratories, CROs)
EMA Inspection follow-up support
- As part of post-inspection commitment, it was required to re-monitor all AEs in medical charts/ source documents and compare versus CRF entries at 10 Investigator Sites (Hungary, Romania, Poland, Bulgaria, Estonia, Slovakia)
- Lead time for this project was approximately 2 weeks
- Auditor CVs had to be approved by EMA inspectors beforehand
- Information on AEs, Concomitant Medication and Medical History had to be collected and documented within 10 working days, with 1 or 2 auditors on-site. Duration of the visits between 1-6 days, depending on number of patients to be checked
- In total, 36 man-days were needed
- Results were submitted to the EMA in due time and EMA authorization for this product was granted by the EMA without delay
Audits were carried out to six “Excellence” sites selected by a national regulatory authority, to confirm that these sites were worthy of the excellence status and qualified to participate in cancer trials supported by the regulatory authority and conduct clinical trials in compliance with ICH-GCP, applicable regulatory requirements and all trial related aspects.
The audit programme was conducted during a clinical trial with patients with advanced Chondrosarcomas by auditors speaking the country language and were completed within approximately 18 months. Compliance with applicable standards was confirmed.
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