OBJECTIVE:
To lay down the procedure for usage of equipment logbooks.
SCOPE:
This SOP is applicable to the procedure for usage of equipment logbooks.
RESPONSIBILITY:
Initiator Officer/Designee: Production shall perform the operation activity as per SOP.
Initiator Executive/Designee: Production shall ensure the compliance of the SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
PROCEDURE:
Equipment logbooks are essential in the pharmaceutical industry to ensure quality and compliance. They provide a detailed history of each piece of equipment, including maintenance, calibration, and usage. This information is crucial for tracking equipment performance, identifying potential issues, and ensuring that products are manufactured to the highest standards.
Logbooks must be accurately maintained and readily accessible for audits and inspections. They serve as a vital record for demonstrating compliance with regulatory requirements and Good Manufacturing Practices (GMP).
The user department shall receive equipment usage log book from QA department as per procedure.
QA personnel shall enter the details on logbook namely Equipment Name,., Logbook No., & start date of the logbook.
Separate logbook will be issued for individual equipment and area where multiple equipments are there.
Production personnel shall read the instructions provided in log book before making entries in log book.
Equipment log book consisting of eight columns namely Date, Product /Activity, Batch number, Time in hours (from, to), Done by, Checked by and Remarks columns.
In the “Date” column the date on which the activity is being performed shall be written in DD/MM/YY manner.
“Product / Activity” columns shall be filled with product name of which is processed in case of operation and type of cleaning in case of cleaning.
In the “Batch number” column Batch number shall be filled in case of operation and “NA” shall be put in case of cleaning.
In the “Time” column shall be filled with the time at which activity started and the time at which the activity completed.
The time column shall be entered in 24 hours format. Ex.: 6AM as 06:00. And 6PM as 18:00.
The personnel who have performed the activity shall sign in “Done by” column. “Checked by” column shall be signed by the person who checked the activity.
Miscellaneous entries / information should be entered in “Remark” column.
Any blank space in the logbook shall be strike off & filled with “NA”.
Completed logbooks shall be signed off by concern HOD and returned to QA putting “End Date”.
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/usage-of-equipment-logbooks/
REFERENCES:
Not Applicable
ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Production
Master Copy : Quality Assurance Department
ABBREVIATIONS:
| PD | : | Production |
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| BMR | : | Batch manufacturing record |
| IPQA | : | In process Quality Assurance |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | Write the date Manual |
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/usage-of-equipment-logbooks/
