The logbook is the original audit trail mechanism as predicated in Eudralex, Volume 4, Chapter 4, Section 4.31.  Is it too simple to automate or are we addicted to the simplicity of using them?  Regardless, the industry struggles to automate the review of one of the simplest controls.  In 2024, there were twenty-nine inspectional FDA 483s due to the lack of logbook upkeep and QA/QC review.

A critical aspect often overlooked with these paper logs is their monitoring frequency.  When conducted properly, periodic logbook reviews:

  • Ensure adherence to regulatory requirements and internal SOPs;
  • Verify that all entries are accurate, complete, and timely;
  • Help identify patterns or recurring issues that need to be addressed; and
  • Enhance readiness for inspections by regulatory bodies, ensuring that all records are up-to-date and accurate.

The premise behind a logbook review is equivalent to that of an electronic system audit trail review.  According to the FDA’s Data Integrity and Compliance with Drug CGMP: Questions and Answers: Guidance for Industry (December 2018):

“8.  How often should audit trails be reviewed?

If the review frequency for the data is specified in CGMP regulations, adhere to that frequency for the audit trail review.  For example, § 211.188(b) requires review after each significant step in manufacture, processing, packing, or holding, and § 211.22 requires data review before batch release.  In these cases, you would apply the same review frequency for the audit trail.

If the review frequency for the data is not specified in CGMP regulations, you should determine the review frequency for the audit trail using knowledge of your processes and risk assessment tools.  The risk assessment should include evaluation of data criticality, control mechanisms, and impact on product quality.

Your approach to audit trail review and the frequency with which you conduct it should ensure that CGMP requirements are met, appropriate controls are implemented, and the reliability of the review is proven.”

Is logbook review one size fits all?  Usually not.  Beyond data review principles, QC or QA should also base their review frequency on operational factors such as:

  • Criticality:  The criticality of the data in contrast to the maximum amount of time for the detection of aberrant data or data loss that the organization is willing to tolerate upon conducting a periodic review
  • Volume:  The quantity of data entries or the number of recordable transactions on each reviewable page of the logbook; meaning, the greater the volume of entries, the more frequent the review
  • Enduring:  The risk of damage or loss of the logbook based on its proximity to harsh environments, such as near water, chemicals, or movements of personnel, materials, and equipment

There are multiple examples in manufacturing and laboratories where the logbook review frequency is derived from both operational use and data risk.  For instance, the recording of analytical results in a QC commercial laboratory notebook that supports product release should be reviewed either prior to the issuance of a CoA or continuously (e.g., high-risk data).  Similarly, a logbook data review conducted in conjunction with the batch record review, or the daily recording of incoming materials within the warehouse, should be more frequent (e.g., a high volume of entries).  Conversely, an air-handler equipment log that records a monthly HEPA-filter differential-pressure check may require reduced surveillance (e.g., low volume of entries, lower risk data).  Finally, a room cleaning log for a class C environment stored in a personnel airlock might necessitate a more frequent review cycle due to the potential for damage or misplacement.

Until paperless manufacturing and digital lab environments render paper logbooks obsolete, QC and QA should consider operational and data criticality risks when determining the review frequency of these indispensable documents.

If you or your firm need advice regarding audit trails or any issues related to the integrity of data generated at your firm, Lachman can help!  Please contact us at LCS@LachmanConsultants.com for a consultation.