GCP Audits

The FDA issued a press statement in August 2009, detailing plans to clamp down on non-compliant investigators and enhance its debarment and disqualification measures. According to OutsourcingPharma.com, FDA warning letters to clinical trial investigators have increased by 50 percent in 2009 as a consequence of improved processes at Division of Scientific Investigations (DSI).

To prepare your company for FDA inspections, Polaris can perform GCP Audits of both domestic and international sites in the following areas.

Vendor Qualification GCP Audits

• Inspect raw material, packaging components, clinical supplies, and finished product manufacturers
• Inspect clinical and nonclinical laboratory facilities
• Evaluate clinical sites to determine if they have the facilities and trained personnel to effectively conduct the study
• Review documentation for potential clinical investigators prior to initiating a clinical study to verify whether an investigator has been inspected by the FDA and if disqualification occurred
• Assess the capabilities of CRO, EDC, and IVRS vendors to determine if they are capable of managing specific studies or clinical programs
• Assess Vendor Certification programs
• Assess qualifications of personnel
• Review SOP content
• Perform follow-up audits annually or semi-annually

Investigator / Study Site GCP Audits

• Assess compliance with FDA regulations and guidelines, International Conference on Harmonization (ICH) guidelines, the sponsor/CRO’s SOPs, and the protocol
• Review records and procedures concerning interactions with the IRB
• Inspect study-required facilities and equipment
• Review records and procedures concerning test article accountability, Adverse Event reporting, human subject protections, and subject enrollment criteria
• Verify that the data collected in a representative sample of Case Report Forms are supported by source documents

Sponsor / Contract Research Organization GCP Audits

• Verify that the protocol is performed according to applicable regulations, guidelines, and standards
• Review procedures for site visits and the records to documents the visits, such as monitoring reports and logs
• Review the qualifications of the CRO team
• Review the organization and content of Clinical Trial Master Files and Essential Documents
• Review the content of SOPs to ensure procedures and systems used in the conduct of clinical trials are in compliance with applicable guidelines and regulations, including SOPs for AE/SAE reporting, subject randomization, study supplies distribution, clinical monitoring, and data handling

Institutional Review Board GCP Audits

• Assess compliance with FDA regulations and ICH guidelines
• Review records and documentation of meetings and expedited review
• Evaluate the databases used to track SAEs and IND Safety Reports
• Review training records for IRB members
• Review content of SOPs
• Assess compliance with internal SOPs

GCP Inspection Readiness

• Conduct Mock Pre-approval Inspection Audits
• Assist personnel to prepare for Pre-approval Inspections by regulatory authorities

Why wait until an FDA inspection to find compliance issues or deficiencies in your clinical practices? By contacting Polaris  today, you can ensure that your facility has properly implemented Good Clinical Practices procedures that FDA auditors will be looking for. Polaris is readily available to assist you in understanding and implementing FDA GCP regulations and ICH guidelines via GCP auditing and training.