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SOP for Odor Testing in Gels

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SOP for Odor Testing in Gels

Standard Operating Procedure for Odor Testing in Gels

1) Purpose

The purpose of this SOP is to establish procedures for evaluating the odor of gel formulations to ensure product consistency and consumer acceptability.

2) Scope

This SOP applies to all personnel involved in odor testing of gel products within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control (QC) Analyst: Perform odor testing according to this SOP.
Formulation Scientists: Provide input on odor characteristics and acceptable ranges.
Quality Assurance (QA) Team: Review and approve odor testing procedures and results.

4) Procedure

4.1 Sample Preparation
4.1.1 Prepare samples according to specified guidelines to ensure representative analysis.
4.1.2 Ensure samples are stored under appropriate conditions prior to testing.

See also  SOP for Maintaining Sterility in Gels Production

4.2 Odor Evaluation
4.2.1 Conduct odor testing in a controlled environment free from interfering odors.
4.2.2 Use a panel of trained evaluators to assess the odor of the gel samples.

4.3 Testing Method
4.3.1 Follow a standardized protocol for sniffing and evaluating the samples.
4.3.2 Record descriptors and intensity ratings for each sample.

4.4 Data Collection and Analysis
4.4.1 Collect and compile data from the panel evaluations.
4.4.2 Analyze the data to determine if the

odor of the samples is within acceptable limits.

4.5 Reporting and Documentation
4.5.1 Document odor testing procedures, results, and analysis comprehensively.
4.5.2 Maintain detailed records of odor testing for batch records and regulatory compliance.

See also  SOP for Compatibility Testing of Gels with Packaging Materials

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

– Odor Testing Records
– Panel Training Records
– SOP for Sample Preparation and Handling

7) Reference, if any

– ASTM E1207-09: Standard Guide for Sensory Evaluation of Products by the Labeled Magnitude Scale
– ISO 8586:2012: Sensory Analysis—General Guidelines for the Selection, Training, and Monitoring of Selected Assessors and Expert Sensory Assessors
– Company-specific odor testing guidelines

8) SOP Version

Version 1.0

Gels Tags:Analytical Method Development for Gels, Assay of Active Ingredient in Gels, Cleaning Equipment for Gel Production, Contamination Prevention in Gel Manufacturing, Equipment Calibration for Gel Manufacturing, Final Product Inspection for Gels, Gel Formulation Development, Gel Homogeneity Testing, Gel Labeling Procedures, Gel Preparation SOP, Gel Production Documentation, Gel Production Waste Disposal, Gel Quality Control Testing, Gel Viscosity Testing, In-process Testing for Gels, Microbial Testing of Gels, Packaging of Gels, Particle Size Analysis in Gels, Particle Size Distribution in Gels, pH Testing of Gels, Pharmaceutical Gel Manufacturing, Process Optimization for Gel Manufacturing, Process Validation for Gels, Raw Material Inspection for Gels, Rheological Testing in Gels, Sample Collection for Gel Quality Testing, Stability Testing for Gels, Sterility in Gel Production, Storage Conditions for Gels, Training for Gel Production Personnel

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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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