Standard Operating Procedure for Timer Settings and Logging Parameters in Elixir Manufacturing Equipment

Department	Elixir Department
SOP No.	SOP/ELX/146/2025
Supersedes	SOP/ELX/146/2022
Page No.	Page 1 of 10
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To establish a procedure for setting and monitoring timers and for recording critical processing parameters during the manufacturing of elixirs, ensuring accuracy, reproducibility, and compliance with GMP requirements.

2. Scope

This SOP applies to all equipment fitted with programmable timers or automated recording systems such as mixers, blenders, heating vessels, filtration units, and filling machines used in the Elixir Department.

3. Responsibilities

• Production Operator:
  • Set timers and monitor process durations as per BMR instructions.
  • Record actual start and end times and any discrepancies.
• Engineering Department:
  • Ensure timer functionality and calibrate controllers periodically.
• QA Officer:
  • Review timer logs and verify recorded parameters for compliance.

4. Accountability

The Production Head is accountable for ensuring the correct use of timers and log maintenance. The Engineering Head is responsible for timer accuracy and preventive maintenance.

5. Procedure

5.1 Timer Setting Guidelines

1. Verify that the equipment is powered ON and in standby mode before setting the timer.
2. Refer to the BMR or MFR for the required time duration (e.g., mixing for 30 minutes at 100 RPM).
3. Use the digital panel or rotary dial to enter the exact time (HH:MM:SS format if applicable).
4. Ensure the “Auto Stop” function is enabled where available.
5. Cross-verify timer settings with another operator or supervisor if batch-critical.

5.2 Logging Parameters During Operation

1. Record the start time, end time, and total run duration in the Timer Logbook (Annexure-1).
2. For automated equipment, ensure the system generates a digital log file.
3. In case of power failure or manual override, document the deviation and restart timing as directed by QA.

5.3 Deviations and Manual Overrides

1. Any change in timer setting after operation has begun must be justified and approved by QA.
2. Record the reason, authorized personnel name, and time of change in the logbook.
3. Do not use handwritten corrections in digital logs; use appropriate software versioning if editing is required.

5.4 Post-Operation Timer Reset

1. Once the operation is complete, reset the timer to “00:00:00” or switch off the unit if no longer in use.
2. Clean the panel or timer knob using a dry lint-free cloth. Do not use solvents.
3. Label the equipment as “READY FOR NEXT USE” or “TO BE CLEANED” as applicable.

5.5 Preventive Maintenance and Calibration

1. All timer-equipped equipment must undergo functionality checks monthly.
2. Engineering to perform calibration every 6 months or earlier if malfunction is suspected.
3. Update calibration and maintenance logs accordingly.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• MFR: Master Formula Record

7. Documents

1. Timer and Parameter Logbook (Annexure-1)
2. Equipment Calibration Certificate
3. BMR for corresponding batch

8. References

• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
• ICH Q8 – Pharmaceutical Development
• WHO TRS 1010 – Process Control Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Timer and Parameter Logbook

Date	Equipment ID	Start Time	End Time	Total Time	Set Parameters	Operator	Remarks
11/04/2025	MXR-ELX-03	09:15	09:45	30 min	100 RPM @ 65°C	Sunita Reddy	Process Completed

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial SOP Release	New SOP	QA Head
11/04/2025	2.0	Added section on deviations and reset procedure	Process Enhancement	QA Head