Audit Based on Objective Evidence: Undebatable outcome
In the pharmaceutical industry, audits are essential for ensuring compliance, maintaining product quality, and safeguarding patient safety. They provide a systematic method to assess processes, identify gaps, and drive continuous improvement. The credibility and effectiveness of an audit depend on the quality of the evidence used to support its findings. Objective evidence—which is factual, verifiable, and unbiased—is the foundation of a credible audit process and leads to undeniable results.
Unlike subjective opinions or assumptions, objective evidence is based on documented records, observable facts, and data that can be independently verified. It is also important to correlate the non-conformity with the exact clause of the guidelines to eliminate any potential defence from the auditee. If the guideline does not clearly state the requirement of a specific aspect, these should be discussed on a case-by-case basis considering the potential risk and implementation of equivalent or better controls. Thorough risk assessment can also be an option in such cases, but the adequacy of this must be assessed during the audit supported by objective evidence when determining non-conformities.
Auditors should verify data integrity, traceability, and consistency to ensure compliance with regulatory standards for GxP and data integrity guidelines, as well as industry practices. It is important to specify the name/number, identity, location, date/time of personnel, document, equipment, or system and issue while giving specific observations as non-conformities.
Real-Time Examples for audits based on objective evidence
Objective evidence is critical for identifying compliance gaps and ensuring accurate audit findings. Here are some real-world examples:
Example: 1
During the authority inspection of the site based in South Africa, it was observed that the firm did not adhere to the appropriate written procedures designed to prevent microbiological contamination of drug products that are claimed to bse sterile. Additionally, there was a lack of validation for all aseptic and sterilization processes.
Objective Evidence:
• Operators blocked first air by placing their gloved hands directly over open sterilized bottles without clearing them from the aseptic filling line xx dated yy.
• Operators used their gloved hands instead of using appropriate sterile tools to remove jammed bottles.
• Operator movements in the critical areas xx were not always slow and deliberate.
• Operators used gloves that had numerous open holes and therefore had exposed skin during line set-up and aseptic processing.
Example 2:
During another authority inspection, a pharmaceutical warehouse was found to have repeated temperature excursions in a storage area for biologics.
Objective Evidence:
• Temperature monitoring logs abc showed multiple excursions (ranging from xx to yy°C) outside the required 2–8°C range over a three-month period from Jan to March 2024 in warehouse Z area.
• The alarm system for the storage unit abc was not functioning, as confirmed by maintenance logs ab and cd.
• Warehouse staff with ID 1234 admitted during interviews that they were unaware of the excursions due to lack of alarm notifications.
Example 3:
During an inspection of a pharmaceutical manufacturing facility, auditors identified data integrity issues in the quality control laboratory. Analysts were found to be manipulating chromatographic data to meet acceptance criteria.
Objective Evidence:
Audit trails of project abc from the chromatography software showed repeated deletions and reprocessing of data files; few examples noted were in raw x, y and x dated 1st Jan, 2nd Jan and 3rd Jan 2024 respectively.
Raw data files of product batch no. xx dated 2nd Jan 2024 did not match the final reported results in the report no. xyz.
Interviews with analyst with employee ID xx revealed that they were instructed to “tweak” data to avoid batch failures.
Example 4:
Another inspection of a European API manufacturing facility found that cleaning procedures for shared equipment were inadequate, leading to potential cross-contamination.
Objective Evidence:
• Swab test results from equipment with ID XX surfaces showed residues of active pharmaceutical ingredients (APIs) above acceptable limits of NMT yy; the actual results were a, b & c in three different cases.
• Cleaning validation record with Report no. abc was incomplete and did not cover all product contact surfaces for the product xyz.
The a, b, c, x, y in these examples are the actual identity of the areas, documents, location etc. and these examples demonstrate how audit based on objective evidence ensures that audit findings are accurate, defensible, and actionable with the actual identity of the areas, systems, documents and location to have no ambiguity at the later stage.
How to Ensure Audits Are Based on Objective Evidence
Audit Planning: Auditors should understand the site’s processes, regulatory requirements, and risks. Focus on site introduction and pre-audit documents to gain an overview of the site’s areas and systems before the audit date.
Document Review: Auditors review batch records, SOPs, validation reports, and CAPA documentation to identify compliance gaps. It’s crucial to note these gaps accurately with objective evidence and discuss them with the audit person if any explanations are needed.
On-Site Verification: They perform on-site inspections to ensure documented processes match actual practices. Sometimes non-conformities are noted without specifying the document or area, causing confusion and potential rejection of the non-conformity.
Evidence Collection: Auditors gather and analyse objective evidence to support their findings. Improper analysis can result in over- or under-categorizing non-conformities.
Final Reporting: Findings are presented in a clear, fact-based report with actionable recommendations. Once the audit is completed, obtaining further objective evidence is typically not possible.
Consequences of not following an evidence-based audit approach;
Regulatory Non-Compliance: Audits that rely on assumptions or incomplete information may miss critical compliance gaps, leading to regulatory citations, warning letters, or even facility shutdowns.
Possible Conflict Between Auditor & Auditee: If observations lack objective evidence, the auditee may dispute or deny the non-conformities cited during the audit, leading to conflict at the closing meeting or afterward.
Client dissatisfaction: If the audit report lacks objective evidence and specific examples of areas of concern, clients may be unhappy with the outcome. Conflicts between auditee and auditor can also lead to client dissatisfaction.
Lead to ineffective audits: Without sufficient objective evidence, non-conformities may result in inadequate responses or CAPA by the auditee. This can hinder improvements in critical areas and lead to ineffective audits.
Business Suspension: If conflicts remain unresolved and the customer is dissatisfied with the audit results or improvements, the vendor’s suspension may occur, leading to losses for both the client and the auditee.
Conclusion:
Objective evidence serves as the foundation of an effective audit, guaranteeing that the findings are precise, justifiable, and in accordance with regulatory standards. This leads to audits that are clear, indisputable, and straightforward. Furthermore, it fosters a mutual understanding among all parties involved, including clients, auditees, and auditors, facilitating a seamless completion of the auditing and supplier qualification/ requalification processes. Conversely, neglecting an evidence-based audit can result in dissatisfaction, disputes, or even the suspension of vendors, ultimately wasting the time and resources of all parties concerned. By implementing an evidence-based methodology, pharmaceutical companies can uphold compliance, reduce risks, and cultivate trust with regulators and stakeholders.
For companies lacking a global vendor auditing team, third-party auditing organizations such as PHARMALANE UK are essential in conducting thorough Quality Auditing Services by following the principle of evidence-based auditing. By utilizing documented, traceable, and verifiable information, we assist pharmaceutical companies in ensuring compliance, reducing risks, and preparing for regulatory inspections. We guarantee that audits are conducted effectively, free from conflicts, and that genuine results are communicated during the supplier qualification and requalification processes.
For inquiries regarding objective evidence-based audits or assistance in conducting vendor audits effectively and efficiently across the globe, please contact us at info@pharmalaneuk.com