SOP Guide for Pharma

API Manufacturing: SOP for Issuance and Control of Logbooks – V 2.0

Auditor

API Manufacturing: SOP for Issuance and Control of Logbooks – V 2.0

Standard Operating Procedure for Issuance and Control of Logbooks in API Manufacturing

Department API Manufacturing
SOP No. SOP/API/183/2025
Supersedes SOP/API/183/2022
Page No. Page 1 of 14
Issue Date 14/04/2025
Effective Date 16/04/2025
Review Date 14/04/2026

1. Purpose

To define the procedure for issuance, numbering, usage, control, review, and archival of logbooks used in API manufacturing to maintain Good Documentation Practices (GDP), ensure traceability, and support data integrity.

2. Scope

This SOP applies to all departments involved in the manufacturing, quality control, engineering, and warehouse operations that use logbooks for recording GMP-relevant data,

observations, equipment usage, maintenance, and other activities.

3. Responsibilities

  • QA Department: Responsible for issuing logbooks with controlled numbering and maintaining the master logbook index. QA shall also perform periodic reviews.
  • Department Heads: Ensure that logbooks are used as per SOP and stored securely when not in use.
  • All Users: Record data in logbooks legibly, promptly, and accurately in compliance with GDP principles.
See also  API Manufacturing: SOP for Batch Release Authorization by QA - V 2.0

4. Accountability

The Head of Quality Assurance is accountable for the implementation and oversight of logbook control across all GMP areas.

5. Procedure

5.1 Logbook Types and Usage

  1. Logbooks include but are not limited to:
    • Equipment usage logs
    • Cleaning logs
    • Calibration logs
    • Temperature/humidity logs
    • Filter integrity records
    • Area entry/exit records
    • Maintenance logs

5.2 Logbook Format

  1. Each logbook shall:
    • Be hardbound (spiral binding not allowed)
    • Have pre-numbered pages
    • Include the following on the cover:
      • Department
      • Logbook Title
      • Logbook Number
      • Issued by
      • Issue Date

5.3 Logbook Numbering System

  1. Logbook numbers shall follow the format: [Department Code]/LOG/[Serial Number]/[Year] (e.g., API/LOG/003/2025)
  2. Logbook serial numbers must be continuous and unique for each department.

5.4 Issuance of Logbooks

  1. Department shall raise a Logbook Request Form (Annexure-1) to QA for new logbooks.
  2. QA shall issue the logbook and record issuance details in the Logbook Issue Register (Annexure-2).
  3. Logbooks shall only be issued by authorized QA personnel.

5.5 Usage Guidelines

  1. Each entry shall be made in black or blue permanent ink only.
  2. Overwriting is not permitted. Corrections shall be made by striking a single line and initialing with date.
  3. Each entry must include:
    • Date
    • Time (if applicable)
    • Observation or activity recorded
    • Initials of person recording
  4. Blank spaces shall be struck through with diagonal lines and initialed.
See also  API Manufacturing: SOP for Color and Odor Assessment in Intermediates - V 2.0

5.6 Periodic Review and Closure

  1. QA shall review each logbook at defined intervals (monthly or quarterly) for:
    • Legibility
    • Completeness
    • Corrections and deviations
  2. Once filled, the user department shall return the logbook to QA for review and closure.
  3. QA shall sign the Logbook Closure Form (Annexure-3) and update the status in the master register.

5.7 Archival and Retention

  1. Closed logbooks shall be retained in the QA Document Archive Room.
  2. Retention period: Minimum 5 years from date of closure or as per regulatory/customer requirement.
  3. Archival details shall be recorded in the Logbook Archival Register (Annexure-4).

5.8 Handling Lost or Damaged Logbooks

  1. Any lost or damaged logbook must be immediately reported to QA.
  2. QA shall initiate a Deviation Report and conduct an investigation to assess data impact.
  3. A replacement logbook shall be issued with reference to the deviation.

6. Abbreviations

  • QA: Quality Assurance
  • GDP: Good Documentation Practices
  • SOP: Standard Operating Procedure

See also  API Manufacturing: SOP for pH Monitoring During Reaction - V 2.0

7. Documents

  1. Logbook Request Form (Annexure-1)
  2. Logbook Issue Register (Annexure-2)
  3. Logbook Closure Form (Annexure-3)
  4. Logbook Archival Register (Annexure-4)

8. References

  • WHO GMP Guidelines – Documentation
  • 21 CFR Part 211.180 – Records and Reports
  • ICH Q7 – Section 6: Documentation and Records

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Logbook Request Form

Department Logbook Type Requested By Date
API Manufacturing Equipment Usage Log Rajesh Kumar 10/04/2025

Annexure-2: Logbook Issue Register

Logbook No. Department Issued By Issue Date
API/LOG/005/2025 API Sunita Reddy 11/04/2025

Annexure-3: Logbook Closure Form

Logbook No. Department Closure Date QA Reviewer
API/LOG/005/2025 API 12/04/2025 QA Officer

Annexure-4: Logbook Archival Register

Logbook No. Storage Location Retention Until Remarks
API/LOG/005/2025 QA Archive Shelf A2 12/04/2030 Archived

Revision History:

Revision Date Revision No. Details Reason Approved By
01/01/2022 1.0 Initial Release New SOP QA Head
14/04/2025 2.0 Included deviation handling and archival tracking Process Improvement QA Head
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