Pharmaceutical and Medical Device organisations are required to assess the safety or efficacy of products manufactured for clinical trials or market use. Companies either use internal or external laboratories to conduct these assessments.
SeerPharma has expertise and deep knowledge of the relevant best practices according to the OECD Principles of Good Laboratory Practice. Our team has the experience and capability to conduct audits of all types including facilities; process data; study-specific data and reports against GLP requirements.
We audit central laboratories and bio-analytical laboratories for routine and specialised analyses against both GLP and GCLP requirements.
The following are the typical regulations and standards SeerPharma is requested to audit against:
Regulations and Standards
- ISO/IEC 17025:2017
- OECD Principles of Good Laboratory Practice
- FDA Bioanalytical Method Validation – Guidance for Industry
- ICH Q2 Method Validation
- 21 CFR Part 11 Electronic Records, Electronic Signatures
Contact us to learn more about our GLP/GCLP auditing services, or click the below button to learn about our range of GxP auditing services.
