GCP Audit Checklist for Pharmaceutical Facilities
Good Clinical Practice (GCP) is a global standard for ethical and quality principles in clinical research. The goal of GCP is to ensure the safety and rights of all participants, alongside ensuring reliable trial data.
GCP covers a diverse range of topics, from informed consent documentation to accurate data reporting. Abiding by GCP principles is crucial to creating public trust in medical research, handling participant information, and accurately reporting results.
Compliance with GCP is critical for the ethical integrity of any clinical study.
GCP auditing aims to evaluate an organization’s compliance and then provide corrective actions if necessary.
What is a GCP audit, and what items does it investigate? Keep reading to learn more about the different types of audits and a comprehensive checklist that auditors use to evaluate your organization.
What is a GCP Audit?
What is good clinical practice auditing? These thorough inspections aim to ensure clinical trials adhere to specific guidelines. A GCP auditor evaluates compliance with all applicable regulations, participant rights and safety, data integrity, and qualifications of investigators. The process also includes ensuring the correct handling of investigational products, data management, and the adequacy of facilities.
These audits are carried out by regulatory authorities and can occur at any stage of a trial to guarantee ethical conduct, safety, and reliable results. FDA
good clinical practice regulations must be adhered to, or there may be fines and other penalties, making it crucial to have the right personnel and systems in place to pass these audits.
Good Clinical Practices Audit Types
GCP compliance audits evaluate several different aspects of a clinical trial. These types of audits serve different purposes and take varying forms, including:
- Site audits: This type of audit evaluates the sites being used for clinical trials. These comprehensive evaluations examine how a specific site conducts trials, ensures the safety of participants, manages data, and ensures overall adherence to GCP principles.
- Monitoring audits: A monitoring audit focuses on the activities specific to monitors and trial management. They focus on the processes and effectiveness of monitoring participants and results, ensuring the trial is conducted in accordance with GCP regulations.
- Full clinical trial audits: A full clinical trial audit covers the entire clinical study at trial sites. This extensive audit covers all aspects of the trial from start to finish, including how participants are recruited, data collection, and reporting processes.
- CRO audits: A Contract Research Organization (CRO) is an organization that manages clinical trials on behalf of sponsors. CRO audits evaluate compliance with GCP standards, similar to other audits, and often extend to personnel qualifications.
Each type of audit in clinical trials is crucial to overall GCP compliance. Your organization needs the right people involved to ensure all practices are fully adherent and adequately documented.
Good Clinical Practices (GCP) Facility Audit Checklist
Auditors will follow a checklist when evaluating your organization's adherence to GCP good clinical practice guidelines. We’ve put together a similar checklist that auditors will follow to help you understand your current practices and any gaps that need to be addressed.
Facility Audit
| Consulting Area |
|---|
| Is the consulting area's size sufficient for the PI/designated Physician to evaluate participants? |
| Are secure cabinets available for storing confidential documents? |
| Is equipment specific to the trial present in the consulting room? |
| If not, is the procedure area suitably sized and accessible? |
| Does the PI effectively manage and maintain trial visits? (Note: Not applicable in field site situations) |
| Procedure Room |
|---|
| Are all pieces of equipment, like Baumanometers, scales, and lung function machines, correctly calibrated and validated as per protocol? |
| Are there available Standard Operating Procedures (SOPs) for equipment usage? |
| Is the blood sampling area maintained in compliance with infection control standards? |
| Is waste managed in accordance with relevant guidelines, such as those from the Regulatory Authority, site, or government? |
| Procedure Room - Availability of the emergency trolley in the procedure area as required for vaccines and medical devices: Security of the emergency trolley: |
|---|
| Is it locked and key access controlled? |
| Regular checks and documentation of the emergency trolley |
| Management and verification of expiry dates |
| Availability and verification of oxygen and related accessories |
| Advanced Life Support System (ALSS) training for PI and sub-investigators |
| Cardiopulmonary Resuscitation (CPR) training for clinical staff |
| Pharmacy (Investigational Product Storage) |
|---|
| Controlled access, temperature, and humidity in the pharmacy |
| Appropriate storage conditions for vaccines |
| Compliance with approved protocols in investigational product preparation by qualified staff |
| Availability of spillage SOPs for vaccines and related training for the team |
| Maintenance of temperature logs (electronic or manual) |
| SOP for managing electricity or temperature failures in the pharmacy |
| Separate, locked, and clearly marked storage for different Investigational Products |
| Compliance with cold chain requirements for vaccine transport |
| Archive |
|---|
| Existence of an agreement for documentation archiving between Sponsor and Trial Site/CRO |
| Inclusion of the archiving clause in the protocol or contract |
| Clinical Laboratory |
|---|
| Location of the clinical laboratory (on-site or off-site) |
| Documentation of biological sample handling procedures (if the lab is off-site, consider a GLP inspection) |
| Validation of all equipment and testing procedures in the laboratory |
| Accreditation of the laboratory for the tests to be conducted |
| Appropriateness of biological specimens and sharps disposal |
Documentation
| General |
|---|
| Final Protocol Version |
| Investigator's Brochure |
| Information Leaflet |
| Informed Consent Form |
| Case Report Form Samples |
| Additional Written Information |
| Recruitment Advertisement Approval |
| Indemnity/Insurance Documentation |
| Signed Agreements |
| CRF Verification SOP |
| Responsibility Transfer Documentation |
| Approval Documentation |
| Ethics Committee Members List |
| Investigators' CVs |
| Pre-Trial Site Assessment Report |
| DSMB Members List |
| Local Safety Monitor's CV |
| Trial Initiation Documents |
| SAE Reporting Forms and Procedures |
| Laboratory Documents |
|---|
| Normal Value Ranges |
| Laboratory Certifications and Accreditations |
| Quality Control Assessments |
| Validation Methods |
| Investigational Product Documents |
|---|
| IP Label Samples |
| IP Shipping Records |
| Product Condition Maintenance Proof |
| IP Certificates of Analysis |
| Vaccine Accountability Decoding Procedures |
| IP Handling Instructions |
| Diluent Storage and Shipping |
| ICH GCP Section 8.3 |
|---|
| Investigator's Brochure Updates |
| Protocol and Consent Amendments |
| New Investigator Approvals and CVs |
| GCP Training Proof |
| Updated Normal Value Ranges |
| Vaccine Accountability and Use |
| New IP Batch Shipments |
| Communication Records |
Informed Consent
| Informed Consent Process |
|---|
| Was informed consent solicited using a written Standard Operating Procedure (SOP)? |
| Did all participants receive a copy of their signed informed consent form? |
| Is the informed consent form version utilized identical to the one approved by the IEC/IRB? |
| Were consent forms signed by all participants before commencing any study-related procedures? |
Your Next Step in Professional Excellence Awaits
Prepare for GCP Audits with CfPIE
Meeting good clinical practice regulations is crucial but requires specific training and knowledge about these regulations. Learning principles of good clinical practice is necessary to pass these audits.
Earning a good clinical practice certification demonstrates your understanding of GCP principles and your ability to help organizations pass these audits.
Ready to earn your certification? Learn how to identify common issues seen in clinical trials with CfPIE's GCP training course, or explore other related courses:
- GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials
- Basic GMP Training for the QC Laboratory
- Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirements
- Clinical Trial Project Management, Phase 1-4 Best Practices
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