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Ointments: SOP for Ensuring Proper Dispersion of Active Ingredients – V 2.0

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SOP for Ensuring Proper Dispersion of Active Ingredients – V 2.0

Procedure for Ensuring Proper Dispersion of Active Ingredients

Department Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Research and Development (R&D)
SOP No. SOP/Ointment/195
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 define the process for ensuring the proper dispersion of active ingredients in ointment formulations. Proper dispersion is crucial to maintaining uniformity, product stability, and therapeutic effectiveness.

2. Scope

This SOP applies to all personnel involved in the handling, preparation, mixing, and quality control of active ingredients in ointment manufacturing within the Manufacturing, Production, Quality Assurance (QA), Quality Control (QC), and Research and Development (R&D) departments.

3. Responsibilities

  • Production Supervisor: Ensures compliance with the active ingredient dispersion process.
  • Process Operator: Monitors and controls the mixing conditions for uniform dispersion.
  • QA Officer: Verifies uniformity and adherence to dispersion protocols.
  • QC Analyst: Conducts testing to confirm proper distribution of active ingredients.
  • Maintenance Engineer: Ensures mixing equipment operates within defined specifications.
See also  Ointments: SOP for Validation of Cleaning Processes - V 2.0

4. Accountability

The Production Manager is accountable for ensuring that all active ingredient dispersion procedures comply with GMP, FDA, ICH, WHO, and company policies.

5. Procedure

5.1 Selection of Active Ingredients

  • Ensure that active ingredients meet the required specifications and are within acceptable potency limits.
  • Verify the compatibility of active ingredients with the ointment base.
  • Document ingredient selection in the **Active Ingredient Selection Log (Annexure-1).**

5.2 Preparation for Dispersion

  • Confirm that all active ingredients are properly weighed and documented.
  • Ensure that the mixing equipment is calibrated and functioning correctly.
  • Record all pre-dispersion checks in the **Pre-Dispersion Checklist (Annexure-2).**

5.3 Dispersion Process

  • Introduce active ingredients into the ointment base gradually while mixing at a controlled speed.
  • Maintain an optimal **mixing speed of 100-300 RPM** to ensure uniform dispersion.
  • If required, pre-disperse active ingredients in a suitable solvent before incorporation.
  • Ensure continuous mixing for **20-45 minutes**, depending on the ingredient properties.
  • Record dispersion parameters in the **Active Ingredient Dispersion Log (Annexure-3).**
See also  Ointments: SOP for Deaeration of Ointment Mixture - V 2.0

5.4 Quality Control Testing

  • Conduct **uniformity testing** using validated analytical methods.
  • Perform **particle size analysis** to confirm proper distribution.
  • Verify dispersion quality using **microscopic examination.**
  • Document all test results in the **Quality Control Testing Log (Annexure-4).**

6. Abbreviations

  • GMP – Good Manufacturing Practices
  • QA – Quality Assurance
  • QC – Quality Control
  • ICH – International Council for Harmonisation
  • FDA – Food and Drug Administration

7. Documents

  • Active Ingredient Selection Log (Annexure-1)
  • Pre-Dispersion Checklist (Annexure-2)
  • Active Ingredient Dispersion Log (Annexure-3)
  • Quality Control Testing Log (Annexure-4)

8. References

  • ICH Q8 – Pharmaceutical Development Guidelines
  • FDA Guidance on Topical Formulation Processing
  • WHO Guidelines on Manufacturing Quality Control
See also  Ointments: SOP for Developing Ointments for Specific Skin Conditions - 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: Active Ingredient Selection Log

Date Batch No. Active Ingredient Specification Met QA Approval
02/02/2025 OINT-4001 Clotrimazole Yes Approved

Annexure-2: Pre-Dispersion Checklist

Date Batch No. Equipment Checked Ingredients Verified QA Approval
02/02/2025 OINT-4001 Yes Yes Approved

Annexure-3: Active Ingredient Dispersion Log

Date Batch No. Ingredient Added Mixing Speed (RPM) QA Approval
02/02/2025 OINT-4001 Clotrimazole 200 RPM Approved

Annexure-4: Quality Control Testing Log

Date Batch No. Uniformity Test Result Particle Size Analysis QA Approval
02/02/2025 OINT-4001 Pass 98% within range Approved

12. Revision History

Revision Date Revision No. Details Reason Approved By
02/02/2025 2.0 Expanded Dispersion Guidelines Regulatory Compliance QA Head
01/01/2024 1.0 Initial SOP New SOP Implementation QA Head
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
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers 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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