Selected Auditing Services

We were assigned the task to perform a review of a batch record policy and also audit several batches to determine compliance with that policy.

Our auditors began by reviewing all of the procedures and documents that related to the company’s implementation of batch record requirements. 

We compared the content of their procedures to determine whether the overall instructions, carried out correctly, would result in a process that was compliant to FDA expectations.

Once the policy was reviewed, three batches of product were identified and we then audited whether the documentation generated for those batches complied with the company’s procedures.

Finally, a batch currently in production was identified and our auditors directly observed the work to insure that the proper documentation was available to the appropriate personnel and whether the activities were compliant with company policy.

●  Lucid compared policy and procedures for batch record documentation and handling to the requirements.

●  We then performed audits of the complete record for three different batches, which had already been completed.

●  To verify that the records were being completed in a timely manner and that all required information was available to the workers as the tasks were being completed, we also audited a batch in production.

●  The reviews of the batch records included all of the Subpart J, 21 CFR 211.188 requirements, which include dates, equipment identification, lists and tracking numbers for all components, weights and measures of each component, the laboratory control results which show whether the components are within specification, and the proof of packaging inspection.