SOP Guide for Pharma

Tablets: SOP for Reviewing Blending and Granulation Records – V 2.0

Auditor

Tablets: SOP for Reviewing Blending and Granulation Records – V 2.0

Standard Operating Procedure for Reviewing Blending and Granulation Records

Department Tablet
SOP No. SOP/TAB/221/2025
Supersedes SOP/TAB/221/2022
Page No. Page 1 of 5
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

This SOP defines the procedure for reviewing blending and granulation records to ensure that the processes are carried out according to established specifications, regulatory requirements, and internal quality standards. The goal is to verify the consistency and quality of tablet batches.

2. Scope

This SOP applies to the review of all blending and granulation records for tablet manufacturing, covering both the R&D and production processes. It includes the documentation of materials used, process conditions, equipment parameters, and batch outcomes.

3. Responsibilities

4. Accountability

The QA Manager is accountable for ensuring that blending and granulation records are properly reviewed and that any discrepancies or non-conformances are addressed. The Production and QC teams are responsible for ensuring that the records are complete and accurate.

See also  Tablets: SOP for Temperature Adjustment During Film Coating Process - V 2.0

5. Procedure

5.1 Record Review Process

  1. Collect all blending and granulation records for the batch being reviewed, including raw material logs, equipment settings, process conditions, and test results (Annexure-1).
  2. Verify that all necessary records are present and that all fields in the records are properly completed, including date, operator details, and equipment used.
  3. Ensure that the materials used for blending and granulation match the approved master batch record (MBR) and that they meet the required specifications (Annexure-2).

5.2 Verification of Process Parameters

  1. Verify that blending and granulation process parameters (e.g., mixing time, granulation fluid volume, speed, and temperature) are within the defined limits set in the MBR (Annexure-3).
  2. Check that equipment used for blending and granulation is properly calibrated and maintained. Ensure that any deviations from equipment specifications are documented and addressed.
  3. Review batch records for any deviations from established processes or specifications, and ensure that these deviations are investigated and resolved (Annexure-4).

5.3 Review of In-Process Testing

  1. Review in-process testing results, such as granule size distribution, moisture content, and density, to ensure that they meet the specified criteria (Annexure-5).
  2. If any testing results are out of specification (OOS), ensure that a thorough investigation is conducted, and corrective actions are implemented before proceeding with the batch (Annexure-6).
  3. Verify that all in-process test results are documented, and any OOS results are reviewed and approved by the appropriate personnel.
See also  Tablets: SOP for Post-Compression Inspection Process - V 2.0

5.4 Approval and Final Review

  1. Once the blending and granulation records are reviewed and all criteria are met, the QA team shall approve the records (Annexure-7).
  2. In cases where discrepancies are identified, the QA team will work with the Production and QC teams to resolve the issue and re-verify the batch records before approval.
  3. Document the approval of the blending and granulation records in the appropriate review log.

5.5 Documentation and Record Keeping

  1. Ensure that all reviewed blending and granulation records are stored securely and are easily retrievable for future audits or inspections (Annexure-8).
  2. Maintain records for a minimum of 5 years, or as required by applicable regulations.
  3. Ensure that any deviations or discrepancies are properly documented and that corrective actions are followed up and tracked (Annexure-9).

6. Abbreviations

7. Documents

  1. Blending and Granulation Batch Record (Annexure-1)
  2. Material Log (Annexure-2)
  3. Process Parameter Verification Sheet (Annexure-3)
  4. Deviation Report (Annexure-4)
  5. In-Process Testing Log (Annexure-5)
  6. OOS Investigation Report (Annexure-6)
  7. Final Approval Log (Annexure-7)
  8. Record Retention Log (Annexure-8)
  9. Corrective Action Log (Annexure-9)

8. References

See also  Tablets: SOP for Tablet Compression Process - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Blending and Granulation Batch Record

Batch Number Material Used Operator Date Process Parameter Result
Batch123 API, Excipients John Doe 01/03/2026 Mixing Speed 500 rpm

Annexure-2: Material Log

Material Batch Number Supplier Quantity
API Batch123 Supplier ABC 10 kg

Annexure-3: Process Parameter Verification Sheet

Parameter Specification Result Deviation Corrective Action
Mixing Speed 500 rpm 500 rpm None None

Annexure-4: Deviation Report

Deviation ID Description Action Taken Status
DEV001 Tablet hardness out of spec Reprocessed Resolved

Annexure-5: In-Process Testing Log

Test Specification Result Pass/Fail
Granule Size 100-250 µm 180 µm Pass

Annexure-6: OOS Investigation Report

OOS ID Issue Investigation Findings Action Taken
OOS001 Granulation moisture out of spec Inconsistent mixing Reprocessed with adjusted parameters

Annexure-7: Final Approval Log

Batch Number Approved By Approval Date
Batch123 John Smith 06/03/2026

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP creation New process QA Head
01/02/2025 2.0 Added in-process testing and documentation requirements Annual review QA Head
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