Performing a warehouse audit according to Good Distribution Practice (GDP) standards involves evaluating the facility’s compliance with regulations that ensure the quality, safety, traceability, and integrity of pharmaceutical products throughout storage and distribution. Did you know that Acorn Regulatory can perform GDP audits of your warehouse/contract storage site or your own QMS on your behalf?
Here are some tips we find useful for carrying out effective GDP Audits:
- Define the purpose of the audit and confirm the audit scope.
- Determine the audit objectives, scope, checklist, schedule, and areas to review.
- Develop the audit agenda and estimate the time needed to complete the audit.
- Review previous audit reports, changes, or deviations to prepare for the audit.
- Review prior audit findings to confirm they have been effectively closed.
- Use a checklist that aligns with GDP standards and requirements.
- Remain objective, rely on evidence, and stay consistent.
- Communicate clearly and professionally.
- Maintain confidentiality at all times.
- Determine the individuals to be interviewed.
- Review key documents, e.g., procedures, check sheets, licenses, and certifications.
- Audit Execution – Select the key areas to evaluate, the following list is an example:
- Premises and equipment
- Storage conditions
- Cleaning
- Outsourced activities management and supplier qualification
- Change control management
- Deviations, CAPA’s and complaint management
- Destruction of medicinal products
- Pest control management
- Rejects, returns, and product recall management
- Inventory management
- Equipment qualification and calibration
- Receipt and dispatch procedures and processes
- Documentation and records
- Personnel and training
- Transportation
- Security and risk management
- Record non-conformances and observations
- Present a summary of the findings and their classification to the auditee
- Clarify any unclear points
- Set deadlines for Corrective and Preventive Actions (CAPA)
Audit Report:
- Re-instate the scope and objective of the audit
- Summary of audit activities
- Findings (with classifications)
- Recommendations
- CAPA plan and deadlines
Follow-Up:
- Monitor implementation of CAPAs
- Re-audit or verify actions if necessary
If you would like to speak to one of RPs regarding performing an audit of your facility, whether is a warehouse audit or a general GDP compliance audit of your QMS please get in contact with enquiries@acornregulatory.com
