Standard Operating Procedure for Equipment Logbook Maintenance in Biosimilar Upstream Manufacturing
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/117/2025 |
| Supersedes | SOP/BS/117/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 04/05/2025 |
| Effective Date | 06/05/2025 |
| Review Date | 04/05/2026 |
1. Purpose
To establish a uniform procedure for the maintenance of equipment logbooks in biosimilar upstream processing, ensuring proper documentation of usage, cleaning, calibration, and preventive maintenance in compliance with GMP guidelines.
2. Scope
This SOP applies to all equipment and instruments used in upstream operations such as bioreactors, incubators, shakers, water baths, centrifuges, and media tanks located in the biosimilars manufacturing unit.
3. Responsibilities
- Operators: Record usage and cleaning activities in equipment logbooks in real time.
- Maintenance Team: Log preventive maintenance and repair work with relevant documentation.
- QA: Review logbooks periodically and during batch release or audits.
4. Accountability
The Head of Production is accountable for ensuring that all upstream equipment logbooks are updated accurately and retained as per data integrity and documentation policies.
5. Procedure
5.1 Logbook Allocation and Identification
- Assign a unique logbook to each equipment, labeled with:
- Equipment Name
- Equipment ID
- Location
- Use logbooks with pre-printed serial numbers and sequential page numbers.
- Label the front cover with “Equipment Logbook – [Equipment Name]”.
5.2 Types of Entries
- Each logbook must include the following entries:
- Equipment Usage
- Cleaning and Sanitization
- Calibration
- Preventive Maintenance (PM)
- Breakdowns and Repairs
5.3 Entry Guidelines
- Entries must be made in black or blue ink, with no overwriting or blank lines.
- Each entry must contain:
- Date
- Activity performed
- Batch or purpose
- Operator initials and time
- For corrections, strike through with a single line, add justification, and sign.
5.4 Record Retention and Review
- Store completed logbooks in the equipment document archive for at least 5 years.
- QA to perform monthly logbook review and record observations in Annexure-3.
6. Abbreviations
- PM: Preventive Maintenance
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
7. Documents
- Equipment Logbook Template – Annexure-1
- Maintenance Entry Form – Annexure-2
- QA Logbook Review Sheet – Annexure-3
8. References
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- WHO TRS 1019 Annex 2 – GMP for Biological Products
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 Logbook Template
| Date | Activity | Batch/Purpose | Performed By | Remarks |
|---|---|---|---|---|
| 04/05/2025 | Bioreactor CIP | BS-BR-301 | Sunita Reddy | CIP cycle successful |
Annexure-2: Maintenance Entry Form
| Date | Maintenance Type | Description | Performed By | Verified By |
|---|---|---|---|---|
| 03/05/2025 | PM | Agitation Motor Greasing | Vinay Pawar | QA Officer |
Annexure-3: QA Logbook Review Sheet
| Date | Reviewed By | Observation | Corrective Action (If Any) |
|---|---|---|---|
| 04/05/2025 | QA Inspector | No discrepancies found | NA |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Added annexure for QA review and updated log retention policy | Internal audit recommendation |