Laboratory Services / Third Party Laboratory GCLP/ISO 15189 Quality Audits
All laboratory operations must be in strict compliance and adherence to national, international and/or local standards, policies, protocols, legal and regulatory frameworks for health and safety. The team of highly experienced laboratory quality and GCLP specialists are also trained and qualified QMS auditors and site GCLP Laboratory Monitors. We assist laboratories with all aspects of compliance and perform detailed assessment of existing laboratory quality systems and processes, highlight problem areas and recommend improvements, so that laboratories can build quality systems that are appropriate for their operations. Our services include to Set up or enhance Internal and/or External Auditing Program, Conduct Vendor/Supplier Qualification Audits, Equipment and Facility Auditing, IT Quality System Audits, Software Quality Audits, Contract Testing Laboratories Audits and Secondary Packaging. The African continent has recently attracted numerous clinical trials necessitating the need for Clinical Trials Audits. In response, FPA has increased capacity and moved to include in its quality audit portfolio, Clinical Trials Audits. Our team can now conduct study-specific GCLP audits of protocols, investigator sites, master files, pharmacovigilance, databases and reports for a wide variety of clinical studies to ensure that quality is maintained at every stage of the clinical trials. Please contact our customer service for further details on these services.