SOP for Logbook Preparation

PURPOSE

To lay down a procedure for preparing the log book for equipment.

SCOPE

This procedure applies to all equipment situated in PharmaInfo Ltd.

RESPONSIBILITY

Officer Production / Officer QA

ACCOUNTABILITY

Head Production / Head QA

PROCEDURE

• All the equipment must have an individual logbook. 
• All the activity done on equipment shall be recorded in the logbook.
• The logbook contains operational, cleaning, and breakdown/maintenance records.
• The logbook for any equipment shall contain the following parameters:

ALSO READ: SOP for Quality Assurance Department

1. Equipment Name
2. Equipment Identification Number.
3. Department
4. Location
5. Date
6. Name of the product
7. Batch Number
8. Mfg. date
9. Exp. Date
10. Batch Size
11. Operational activity (Procedure time)
12. Done by
13. Checked By
14. Verified By
15. Remarks

• The log shall be prepared in a register form as per Annexure-I.
• Any equipment breakdown must be recorded.
• The log book for breakdown contains the following parameters:

1. Date
2. Details of breakdown
3. Corrective action taken
4. Rectified by
5. Checked by
6. Remarks

• The logbook shall be in a register form as per Annexure II.
• Maintain the records of all equipment as per the log book.

ANNEXURES

Annexure I: EQUIPMENT LOG BOOK

Annexure II: BREAK DOWN LOG BOOK

ABBREVIATIONS

SOP: Standard Operating Procedure

QA: Quality Assurance

REVISION HISTORY

Nil

ALSO READ: SOP for Production Activities as per Safety & cGMP Requirement