including reactors, mixers, homogenizers, pipelines, and packaging lines, which require traceability in batch documentation.

3. Responsibilities

• Production Operator: Ensures correct equipment ID is recorded at each stage of manufacturing.
• Manufacturing Supervisor: Reviews entries and ensures consistency across batch records.
• Quality Assurance: Verifies equipment entries during in-process checks and documentation review.

4. Accountability

Department Head – Manufacturing

5. Procedure

5.1 Identification of Equipment

1. Ensure each piece of equipment is clearly tagged with a unique Equipment ID number.
2. Verify calibration and cleaning status is current and approved before use.

5.2 Recording Equipment Usage

1. At each manufacturing stage, the operator must enter the Equipment ID in the designated column of the BMR/BPR.
2. Include the date and time of use along with operator initials.
3. Record the cleaning verification status and previous product handled.

5.3 Verification and Review

1. The supervisor must cross-check that only validated and approved equipment is listed in the BPR.
2. QA shall verify that equipment usage records align with cleaning logbooks and equipment status tags.

5.4 Documentation Requirements

1. Use only black or blue permanent ink when recording entries.
2. Corrections must be made with a single line strike-through, with date and signature; no overwriting allowed.
3. Ensure that blank fields are not left empty — use ‘NA’ if not applicable.

5.5 Handling Errors or Omissions

1. Any missing or incorrect equipment entry must be investigated and documented using the deviation process.

6. Abbreviations

• BPR: Batch Production Record
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• GMP: Good Manufacturing Practice

7. Documents

1. Equipment Usage Log – Annexure-1
2. Batch Manufacturing Record Template – Annexure-2
3. Equipment Cleaning and Calibration Logs

8. References

• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
• WHO TRS 986 Annex 2 – GMP Guidelines
• Schedule M – Good Manufacturing Practices

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Equipment Usage Log

Equipment Name
Equipment ID
Used For Process Step
Date of Use
Operator Initials
Cleaning Verified	Yes / No
QA Verified	Yes / No

Annexure-2: BMR Equipment Entry Section Template

Manufacturing Step	Equipment Name	Equipment ID	Cleaning Status	Operator Initials	QA Verified
Dispensing
Mixing
Homogenization
Filling

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
10/03/2022	1.0	Initial Issue	New SOP	QA Head
09/06/2025	2.0	Format updates and inclusion of error handling	Annual Review	QA Head