a timely manner.

Health and Safety Officer: Ensures that all safety-related data is accurately documented, particularly any incidents related to machine safety.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that machine operations are properly documented. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Documenting Machine Setup

1. Before starting the machine, document the following setup parameters:
   • Machine ID and operator details
   • Product batch number
   • Machine settings (e.g., speed, pressure, temperature)
   • Filling volume, crimping pressure, or valve testing settings, depending on the machine type
   • Lubrication or cleaning steps performed before setup
2. Ensure that all setup details are recorded in the Machine Setup Log (Annexure-1).
3. Verify that the machine is correctly set up for the current production run and that all necessary safety checks are completed.

5.2. Documenting Machine Operation

1. During production, record the following operational data:
   • Machine ID, operator name, and shift details
   • Production rate (e.g., units per hour)
   • Machine performance parameters (e.g., filling volume, crimping pressure, test results)
   • Time of production start and end
   • Any deviations or irregularities observed during operation
2. Record the operational data in the Machine Operation Log (Annexure-2), ensuring all fields are completed accurately.
3. If any deviations occur during operation, document them in the Deviation Log (Annexure-3) and notify the appropriate team for corrective actions.

5.3. Documenting Maintenance Activities

1. For every maintenance activity performed, document the following:
   • Machine ID and maintenance task description
   • Parts replaced, repaired, or adjusted
   • Maintenance date and time
   • Person responsible for performing the maintenance
   • Any issues identified and resolved during the maintenance process
2. Record all maintenance activities in the Machine Maintenance Log (Annexure-4) and ensure that it is signed by the responsible person.
3. If any parts are replaced, document the part number, supplier information, and warranty details in the equipment maintenance records.

5.4. Documenting Machine Deviations

1. If any deviations are observed during the operation of the machine (e.g., incorrect filling volume, excessive pressure), immediately stop the machine and investigate the cause.
2. Document the deviation, including the following details:
   • Deviation description (e.g., overfilling, underfilling)
   • Time of occurrence and affected batch
   • Cause of deviation (if identified)
   • Corrective actions taken to resolve the issue
3. Record the deviation in the Deviation Log (Annexure-3), and notify the relevant teams for further action if necessary.

5.5. Documenting Post-Operation Performance

1. After production is complete, document the following post-operation data:
   • Final product quantity produced
   • Performance of the machine (e.g., any issues or downtime during production)
   • Final inspection results (e.g., product quality checks)
   • Operator shift end time
2. Record this data in the Post-Operation Log (Annexure-5), ensuring that all required information is included.

5.6. Document Retention and Review

1. Ensure that all machine operation and maintenance records are stored in accordance with the company’s document retention policy.
2. Review machine operation and maintenance logs periodically to identify any recurring issues or areas for improvement.
3. Ensure that all records are available for audits, quality control checks, and regulatory inspections.
4. Implement any necessary changes based on feedback from the review process to improve machine operations and record-keeping accuracy.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Machine Setup Log (Annexure-1)
2. Machine Operation Log (Annexure-2)
3. Deviation Log (Annexure-3)
4. Machine Maintenance Log (Annexure-4)
5. Post-Operation Log (Annexure-5)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Machine Setup Log

Machine ID	Setup Parameter	Operator Name	Date
F-12345	Filling Volume: 200ml	Rajesh Patel	06/02/2025

Annexure-2: Machine Operation Log

Machine ID	Operator Name	Production Start Time	Production End Time	Production Rate
F-12345	Rajesh Patel	06/02/2025	06/02/2025	250 units/hour

Annexure-3: Deviation Log

Batch No.	Deviation Description	Corrective Action Taken	Operator Name
12345	Underfilling	Adjusted filling machine settings	Rajesh Patel

Annexure-4: Machine Maintenance Log

Machine ID	Maintenance Description	Maintenance Date	Performed By
F-12345	Replaced worn seals	06/02/2025	Rajesh Patel

Annexure-5: Post-Operation Log

Machine ID	Post-Operation Check	Operator Name	Date
F-12345	Inspection completed, no issues found	Rajesh Patel	06/02/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated documentation procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures