SOP Guide for Pharma

Gel Manufacturing: SOP for Performing Weight Checks Before and After Gel Filling – V 2.0

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Gel Manufacturing: SOP for Performing Weight Checks Before and After Gel Filling – V 2.0

Standard Operating Procedure for Performing Weight Checks Before and After Gel Filling in Gel Manufacturing

Department Gel Manufacturing
SOP No. SOP/GM/152/2025
Supersedes SOP/GM/152/2022
Page No. Page 1 of 10
Issue Date 09/06/2025
Effective Date 11/06/2025
Review Date 09/06/2027

1. Purpose

To define the procedure for conducting and documenting weight checks before and after the filling process of gel formulations to ensure uniformity and compliance with pre-established product weight specifications.

2. Scope

This SOP applies to all gel manufacturing batches where manual or automated filling of the finished product is conducted within the production area.

3. Responsibilities

  • Production Operator: Carries out the pre-filling and post-filling weight checks as per batch record instructions.
  • Production
Supervisor: Verifies the results and ensures corrective action in case of deviation.
  • QA Executive: Reviews weight check data and performs periodic audits.

    • 4. Accountability

    The Head – Manufacturing is accountable for the implementation and maintenance of this SOP and for ensuring that accurate records of weight checks are maintained.

    5. Procedure

    5.1 Pre-Filling Weight Check

    1. Ensure balance is calibrated and clean before use.
    2. Weigh 10 empty containers selected randomly from the lot to establish the average tare weight.
    3. Document the individual weights and calculate the average tare weight.

    5.2 Post-Filling Weight Check

    1. Immediately after the start of the filling operation, randomly select 10 filled units at different time intervals.
    2. Record the gross weight of each filled unit using the same balance used for tare weight.
    3. Deduct the average tare weight to determine net fill weight.
    4. Ensure that the net weight falls within the specified limits mentioned in the batch manufacturing record (BMR).

    5.3 In-Process Checks

    1. Repeat the weight checks every 30 minutes or as defined in the BMR.
    2. In case of deviation, stop the line and investigate. Restart only after corrective action.

    5.4 Documentation

    1. All observations shall be recorded in the In-Process Check Record – Annexure-1.
    2. Ensure entries are made using permanent black ink and corrections are counter-signed with reason and date.

    5.5 Line Clearance and QA Oversight

    1. QA shall perform random verification of weight checks during batch processing.
    2. Line clearance before filling must include confirmation of scale calibration and availability of weight check records.

    6. Abbreviations

    • BMR: Batch Manufacturing Record
    • QA: Quality Assurance
    • GMP: Good Manufacturing Practices

    7. Documents

    1. In-Process Weight Check Record – Annexure-1
    2. Balance Calibration Record
    3. Batch Manufacturing Record

    8. References

    • Schedule M – GMP Guidelines for Pharmaceuticals
    • 21 CFR Part 211 – Subpart G: Packaging and Labeling Control

    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: In-Process Weight Check Record Format

    Date Batch No. Time Sample No. Gross Weight Tare Weight Net Weight Within Limits (Y/N) Remarks Operator Sign

    Revision History

    Revision Date Revision No. Change Description Reason Approved By
    10/04/2022 1.0 Initial Issue New SOP QA Head
    09/06/2025 2.0 Updated format and annexures, added frequency clarification Annual Review QA Head
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