data in the approved logbook format during batch execution.

QC Analyst: Review recorded IPC results, ensure legibility and data accuracy.

QA Officer: Approve the logbook format and periodically verify compliance during internal audits or batch review.

4. Accountability

The Production Head is accountable for adherence to documentation practices. The QA Head is accountable for format approval and overall data integrity.

5. Procedure

5.1 Logbook Identification and Control

1. Each IPC logbook shall be uniquely identified with:
   • Logbook Title (e.g., “IPC Logbook – Drying Stage”)
   • Logbook ID Number
   • Department Name
   • Date of Issue
   • Issued By (QA)
2. The cover page shall be stamped and signed by QA before use.

5.2 Logbook Format Requirements

1. Each logbook page must contain a structured table with the following fields:
   • Date
   • Batch Number
   • Stage of IPC (e.g., Drying, Milling)
   • Parameter Checked (e.g., pH, LOD, temperature)
   • Observed Result
   • Acceptance Criteria
   • Observation Time
   • Performed By (Name and Signature)
   • Reviewed By (Name and Signature)
   • Remarks (if any)

5.3 Documentation Instructions

1. Write entries using permanent blue ink only.
2. Ensure entries are clear, legible, and free of overwriting.
3. In case of correction:
   • Strike through the incorrect entry with a single line.
   • Write the correct value above or beside it.
   • Sign, date, and provide reason for correction.
4. Do not leave blank rows. If a row is not applicable, write “NA” and strike it across.
5. Each page shall be signed by the personnel making entries and reviewed by the supervisor or QC officer.

5.4 Logbook Storage and Handling

1. Store logbooks in a dedicated cabinet accessible only to authorized personnel.
2. Do not remove logbooks from the department without QA authorization.
3. Protect logbooks from dust, spillage, and physical damage.

5.5 Closing and Archiving

1. Once filled, the logbook shall be closed with a summary page indicating:
   • Total pages used
   • Period of use (From – To)
   • Summary of any deviations
2. Submit completed logbook to QA for archival.
3. QA shall archive the logbook in the document control room as per SOP for a minimum of 5 years.

6. Abbreviations

• IPC: In-Process Control
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• LOD: Loss on Drying

7. Documents

1. IPC Logbook Template (Annexure-1)
2. Logbook Issue Record (Annexure-2)
3. Deviation Form (if applicable)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
• WHO TRS 986 – GMP 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: IPC Logbook Template

Date	Batch No.	Stage	Parameter	Observed Result	Criteria	Time	Performed By	Reviewed By	Remarks
13/04/2025	API-20250413	Drying	LOD	1.3%	NMT 1.5%	10:30	Ravi Kumar	Sunita Reddy	Complies

Annexure-2: Logbook Issue Record

Logbook ID	Department	Issued By	Date of Issue	Date of Closure	Returned To QA
IPC/DRY/001	Drying	QA Officer	01/04/2025	10/04/2025	13/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
13/04/2025	2.0	Format updated with new annexures and storage procedure	Audit Compliance	QA Head