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The SOP on procedure for making entries in equipment usage log book lays down how the Production department records equipment usage, cleaning and preventive maintenance in the equipment log sheet (Annexure-I). Entries use the 24-hour format, “No Activity” for unused days, cleaning type ‘A’ or ‘B’, and legible writing.
1.0 Objective
This section states the purpose of the SOP, which is to lay down a Procedure for Making Entries in Equipment Usage Log Book. The SOP tells Production officers and executives how to record equipment usage, cleaning and preventive maintenance in the equipment usage log book, using the equipment log sheet in Annexure-I.
2.0 Scope
This section defines where the SOP applies. This SOP applies to making entries in the equipment usage log book in the production department.
3.0 Responsibility
This section names the roles responsible for the SOP. Production officers and executives make the entries, and the Production manager is also named as responsible.
Officer, Executive – Production Department
Manager – Production Department
4.0 Accountability
This section names the role accountable for the SOP. The head of the Production department is accountable for the implementation of this SOP.
5.0 Procedure: SOP on Procedure for Making Entries in Equipment Usage Log Book
This section lists the steps for recording equipment activity in the log sheet. A written log of equipment cleaning, maintenance and use, with the date, time, product and batch, is required by 21 CFR Part 211. Schedule M requires records of equipment use, cleaning and maintenance, and the log sheet in this SOP is how the Production department keeps them. WHO GMP guidance on good documentation practices expects entries to be legible.
5.1 Record the usage, cleaning and preventive maintenance activities (and “No Activity” on days the equipment is idle) in the equipment log sheet (Annexure-I).
5.2 Record the time in 24 Hrs. (24-hour) format.
5.3 Record the time when the equipment is engaged in the process.
5.4 In case the equipment is not used on a particular day, then record the date & mention it as “No Activity” under the activity column.
5.5 Record the date and time of machine cleaning after maintenance or preventive maintenance.
5.6 Record the cleaning, specifying it as type ‘A’ or type ‘B’.
5.7 Ensure that the writing is clear, visible and readable while entering data in the log sheet.
5.8 Ensure that all entries made in the log sheet are legible.
The related SOP is the one on design, print, issuance and control of logbooks. Further reading on equipment handling is available in SOP on cleaning of new equipment/ machinery, SOP on the Removal of Broken Down equipment and Procedure for Handling of Deviations (SOP).
7.0 Abbreviations
SOP: Standard Operating Procedure
Related SOP: Design, Print, Issuance, and Control of Logbooks
| Title | SOP No. | Revision No. | Effective Date | Review Date | Supersedes | Department | Page |
|---|---|---|---|---|---|---|---|
| SOP on Procedure for Making Entries in Equipment Usage Log Book | PRD/XXX | 00 | DD/MM/YYYY | DD/MM/YYYY | NA | Production | 1 of 1 |
Annexure-I:
Frequently Asked Questions
The procedure applies to the production department, where Production officers and executives must record equipment usage, cleaning and preventive maintenance. The entries are made in the equipment log sheet given as Annexure-I.
The time is recorded in 24-hour format. The same format applies to every time entry in the equipment log sheet, including the time when the equipment is engaged in the process, so the usage, cleaning and maintenance records of the equipment remain consistent across the production department.
When the equipment is not used on a particular day, the date is recorded in the log sheet. The words “No Activity” are then written under the activity column against that date. In this way, the log book shows the equipment was idle and no day is left without an entry.
The cleaning of the equipment is recorded as type ‘A’ or type ‘B’. The entry must state which type was carried out. Cleaning done after maintenance or preventive maintenance is recorded with its date and time, and the same type entry is made for it.
10.0 Revision History
This section records the revision status of the SOP. The table below shows the placeholder entry for the first issue.
| Revision No. | Effective Date | Details of Change | Reason for Change |
|---|---|---|---|
| 00 | DD/MM/YYYY | New SOP | NA |
References
- 21 CFR 211.182
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