Procedure for Maintaining Equipment Logbooks
| Department | Production/Quality Assurance (QA)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/152 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic process for maintaining equipment logbooks in pharmaceutical manufacturing. Equipment logbooks ensure proper documentation of equipment usage, cleaning, maintenance, and calibration, which is critical for regulatory compliance, traceability, and adherence to Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel in the Production, Quality Assurance (QA), and Engineering departments responsible for updating, verifying, and archiving equipment logbooks for manufacturing, cleaning, and utility systems.
3. Responsibilities
- Machine Operator: Records equipment usage, cleaning, and maintenance activities.
- Production Supervisor: Reviews logbook entries for completeness and accuracy.
- Engineering Team: Updates calibration and maintenance records.
- QA Officer: Ensures compliance with logbook documentation standards.
- QA Manager: Reviews and approves logbook records.
4. Accountability
The QA and Engineering Managers are accountable for ensuring that all equipment logbooks are maintained in compliance with GMP, FDA, ICH, and WHO regulations.
5. Procedure
5.1 Types of Equipment Logbooks
The following types of logbooks must be maintained:
- Equipment Usage Log: Records details of equipment operation, including date, time, batch number, and operator name.
- Cleaning and Sanitation Log: Documents cleaning and sanitization activities,
including cleaning agents used, cleaning time, and operator signature.
Maintenance and Repair Log: Records preventive and corrective maintenance activities performed by the engineering team.
Calibration Log: Includes records of calibration activities, reference standards used, and results.
Breakdown and Downtime Log: Documents unplanned downtime, cause of breakdown, and corrective actions taken.
5.2 General Guidelines for Maintaining Logbooks
- All logbooks must be maintained at the respective equipment location.
- Entries must be made in **real time** using indelible ink.
- Each entry must be signed and dated by the responsible personnel.
- Logbooks must be reviewed periodically by the Production Supervisor and QA team.
- Logbooks must be bound and paginated sequentially to prevent data tampering.
5.3 Equipment Usage Log Entry Procedure
- Before operating the equipment, the machine operator must enter the following details:
- Date and time of use.
- Batch number associated with the equipment operation.
- Equipment ID and name.
- Start and end time of the operation.
- Operator’s name and signature.
- After completion of batch processing, the log must be verified by the Production Supervisor.
5.4 Equipment Cleaning and Sanitation Log Entry Procedure
- Cleaning logs must be filled after every cleaning cycle.
- The following information must be recorded:
- Date and time of cleaning.
- Cleaning method and cleaning agents used.
- Operator name and signature.
- QA verification signature.
5.5 Equipment Maintenance and Calibration Log Entry Procedure
- The engineering team must update the logbook with the following details:
- Date of maintenance or calibration.
- Type of maintenance (preventive/corrective).
- Parts replaced, if any.
- Reference standards used for calibration.
- Results of calibration.
- Technician name and signature.
5.6 Review and Approval of Logbooks
- Production Supervisors must review logbooks weekly for completeness.
- QA must verify logbooks monthly for compliance.
- Engineering must review calibration logs quarterly.
- Logbooks must be archived securely for at least five years.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- FDA – Food and Drug Administration
- ICH – International Council for Harmonisation
7. Documents
- Equipment Usage Log Template (Annexure-1)
- Equipment Maintenance and Calibration Log Template (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines on Equipment Maintenance
- US FDA Guidance on Equipment Documentation
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Equipment Usage Log Template
| Date | Equipment Name | Batch No. | Start Time | End Time | Operator | Supervisor Verification |
|---|---|---|---|---|---|---|
| 01/02/2025 | Mixing Tank 01 | OINT-1001 | 10:00 AM | 12:00 PM | John Doe | Approved |
Annexure-2: Equipment Maintenance and Calibration Log Template
| Date | Equipment Name | Maintenance Type | Parts Replaced | Calibration Results | Technician | QA Approval |
|---|---|---|---|---|---|---|
| 02/02/2025 | Homogenizer 02 | Preventive | Seals Replaced | Within Limits | Jane Smith | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Procedure | Improved Compliance | QA Head |