Standard Operating Procedure for Maintaining Equipment Logbooks

1) Purpose

The purpose of this SOP is to provide guidelines for the proper maintenance of equipment logbooks to ensure accurate tracking and documentation of equipment usage, maintenance, and calibration activities in the production of ocular dosage forms.

2) Scope

This SOP applies to all equipment used in the production of ocular dosage forms within the pharmaceutical manufacturing facility, including eye drops, ointments, gels, and inserts.

3) Responsibilities

The responsibilities include documenting equipment usage, maintenance, and calibration activities, reviewing logbook entries for completeness and accuracy, and ensuring logbooks are properly maintained and stored. Production staff and maintenance personnel are responsible for recording equipment activities, and quality assurance personnel are responsible for reviewing and approving logbook entries.

4) Procedure

4.1 Preparation

1. Ensure all personnel involved in maintaining equipment logbooks are trained in proper documentation practices.
2. Verify that logbook templates are up-to-date and approved for use.
3. Ensure that logbooks are readily available at the equipment location.

4.2 Logbook Entries

1. Recording Equipment Usage:
   1. Document the date and time of equipment usage.
   2. Record the name of the operator and the purpose of equipment use.
   3. Note any deviations or issues encountered during equipment operation.
   4. Record the batch number or production lot number associated with the equipment usage.
2. Recording Maintenance Activities:
   1. Document the date and time of maintenance activities.
   2. Record the name of the maintenance personnel and the type of maintenance performed.
   3. Detail any parts replaced or repairs made during maintenance.
   4. Note any deviations or issues encountered during maintenance.
   5. Record the status of the equipment post-maintenance (e.g., operational, out-of-service).
3. Recording Calibration Activities:
   1. Document the date and time of calibration activities.
   2. Record the name of the calibration personnel and the equipment calibrated.
   3. Detail the calibration results and any adjustments made.
   4. Note any deviations or issues encountered during calibration.
   5. Record the status of the equipment post-calibration (e.g., calibrated, out-of-tolerance).

4.3 Review and Approval

1. Submit the completed logbook entries to the quality assurance department for review.
2. The quality assurance personnel should review the logbook entries for completeness, accuracy, and compliance with SOPs and regulatory requirements.
3. Any discrepancies or deviations should be investigated, documented, and resolved before approving the logbook entries.
4. Once the logbook entries are approved, they should be signed and dated by the quality assurance personnel.

4.4 Record Maintenance

1. Store the approved logbooks in a secure location to prevent loss or damage.
2. Maintain logbooks for a period specified by regulatory requirements or company policy.
3. Ensure that logbooks are easily accessible for audits and inspections.

5) Abbreviations, if any

N/A

6) Documents, if any

1. Logbook templates
2. Calibration records
3. Maintenance records

7) Reference, if any

GMP Guidelines for Documentation in Pharmaceutical Manufacturing

8) SOP Version

Version 1.0