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Ointments: SOP for Mixing Active Ingredients in Ointment Base – V 2.0

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SOP for Mixing Active Ingredients in Ointment Base – V 2.0

Procedure for Mixing Active Ingredients in Ointment Base

Department Production/Quality Assurance (QA)/Research and Development (R&D)
SOP No. SOP/Ointment/024
Supersedes V 1.0
Page No. Page X of Y
Issue Date [Insert Issue Date]
Effective Date [Insert Effective Date]
Review Date [Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for the uniform mixing of active ingredients into the ointment base. Proper mixing ensures even distribution of active pharmaceutical ingredients (APIs), stability, and efficacy of the final product.

2. Scope

This SOP applies to all personnel responsible for blending APIs with the base in the ointment manufacturing process.

3. Responsibilities

  • Production Supervisor: Ensures proper execution of the mixing process.
  • Machine Operator: Operates and monitors the mixing equipment.
  • Quality Assurance (QA) Personnel: Verifies uniformity and process compliance.
  • R&D Scientist: Provides guidance on mixing parameters during formulation development.
See also  Ointments: SOP for pH Testing of Ointments - V 2.0

4. Accountability

The Production and QA Managers are accountable for ensuring that the mixing process is conducted as per GMP guidelines and documented correctly.

5. Procedure

5.1 Pre-Mixing Preparations

  • Ensure the mixing vessel and all equipment are clean and sanitized.
  • Check that all required ingredients are weighed accurately as per the Batch Manufacturing Record (BMR).
  • Verify the temperature and viscosity of the melted base before incorporating active ingredients.

5.2 Addition of Active Ingredients

  • Slowly add the active ingredient(s)
into the pre-heated ointment base.
  • Ensure uniform dispersion by adding in increments while mixing continuously.
  • Use a homogenizer if required to ensure fine particle distribution.
  • 5.3 Mixing Parameters

    • Maintain a controlled mixing speed to avoid air entrapment.
    • Monitor temperature and adjust as required to prevent degradation.
    • Continue mixing for the time specified in the formulation protocol.
    • Perform a visual inspection to check for consistency.

    5.4 Homogenization (If Required)

    • If further homogenization is needed, pass the mixture through a homogenizer.
    • Ensure particle size reduction to achieve a smooth consistency.
    • Document homogenization settings (speed, pressure, time).

    5.5 In-Process Quality Control Checks

    • Take a representative sample and check for uniformity.
    • Perform pH and viscosity measurements.
    • Ensure compliance with batch specifications before proceeding to cooling.

    5.6 Cooling and Holding

    • Gradually reduce the temperature while maintaining gentle mixing.
    • Prevent crystallization or separation by following controlled cooling parameters.
    • Hold the mixture at the specified temperature before transfer to filling equipment.

    5.7 Documentation and Approval

    • Record all mixing parameters in the Mixing Log.
    • QA must verify the mixed batch before filling.
    • Label the final bulk mixture as “Ready for Filling.”

    6. Abbreviations

    • BMR – Batch Manufacturing Record
    • API – Active Pharmaceutical Ingredient
    • QA – Quality Assurance
    • GMP – Good Manufacturing Practices

    7. Documents

    • Mixing Log (Annexure-1)
    • In-Process Quality Control Report (Annexure-2)

    8. References

    • WHO GMP Guidelines for Pharmaceutical Manufacturing
    • 21 CFR Part 211 – Current Good Manufacturing Practices
    • Equipment Manufacturer 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: Mixing Log

    Date Batch Number Active Ingredient Mixing Speed (RPM) Temperature (°C) Time (Min) Verified By
    01/02/2025 SOP/Ointment/001 API-A 500 65°C 30 QA Officer
    02/02/2025 SOP/Ointment/002 API-B 600 70°C 40 QA Officer

    Annexure-2: In-Process Quality Control Report

    Date Batch Number Test Parameter Specification Result Final Status
    01/02/2025 SOP/Ointment/001 Viscosity 1000-2000 cP 1500 cP Pass
    02/02/2025 SOP/Ointment/002 pH 5.5-7.0 6.2 Pass

    12. Revision History:

    Revision Date Revision No. Details of Revision Reason for Revision Approved By
    01/01/2024 1.0 Initial Version New SOP QA Head
    01/02/2025 2.0 Updated SOP Format Standardization of Document QA Head
    See also  Ointments: SOP for Conducting Accelerated Stability Testing During Development - V 2.0
    Ointments V 2.0 Tags:Ointment application SOP, Ointment batch record SOP, Ointment compounding SOP, Ointment dispensing SOP, Ointment filling SOP, Ointment formulation SOP, Ointment manufacturing SOP, Ointment microbiological testing SOP, Ointment pH testing SOP, Ointment production SOP, Ointment quality control SOP, Ointment stability study SOP, Pharmaceutical ointment SOP, SOP for ointment homogenization, SOP for ointment labeling, SOP for ointment mixing, SOP for ointment packaging, SOP for ointment preparation, SOP for ointment raw material testing, SOP for ointment shelf-life determination, SOP for ointment stability testing, SOP for ointment sterilization, SOP for ointment storage, SOP for ointment testing, SOP for ointment viscosity testing

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    Standard Operating Procedures V 1.0

    • Aerosols
    • Analytical Method Development
    • Bioequivalence Bioavailability Study
    • Capsule Formulation
    • Clinical Studies
    • Creams
    • Data Integrity
    • Dental Dosage Forms
    • Drug Discovery
    • Environment, Health and Safety
    • Formulation Development
    • Gels
    • Good Distribution Practice
    • Good Warehousing Practices
    • In-Process Control
    • Injectables
    • Liquid Orals
    • Liposome and Emulsion Formulations
    • Lotions
    • Lyophilized Products
    • Maintenance Dept.
    • Medical Devices
    • Metered-Dose Inhaler
    • Microbiology Testing
    • Nanoparticle Formulation
    • Nasal Spray Formulations
    • Nebulizers
    • Ocular (Eye) Dosage Forms
    • Ointments
    • Otic (Ear) Dosage Forms
    • Pharmacovigilance
    • Powder & Granules
    • Purchase Departments
    • Quality Assurance
    • Quality Control
    • Raw Material Stores
    • Regulatory Affairs
    • Tablet Manufacturing
    • Rectal Dosage Forms
    • Transdermal Patches
    • Vaginal Dosage Forms
    • Validations and Qualifications

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    NEW! Revised SOPs – V 2.0

    • Aerosols V 2.0
    • API Manufacturing V 2.0
    • BA-BE Studies V 2.0
    • Capsules V 2.0
    • Creams V 2.0
    • Ointments V 2.0
    • Raw Material Warehouse V 2.0
    • Tablet Manufacturing V2.0

    New Publication: A must for All.

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