Skip to content
  • Clinical Studies
  • Schedule M
  • Stability Studies
  • Pharma GMP
  • Pharma Tips
  • Pharma Books
  • Pharma Validation
  • Pharma Regulatory

SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

  • Home
  • Job Safety Analysis (JSA)
    • Oral Dosage Forms (Tablets & Capsules)
    • Oral Liquid Dosage Forms (Syrups, Elixirs, Suspensions, Emulsions)
    • Powder and Granule Dosage Forms
    • Topical Dosage Forms (Creams, Ointments, Gels, Lotions, Pastes)
    • Transdermal Dosage Forms (Patches)
  • Standard Test Procedures (STP)
  • SOP – Blog Post
  • Toggle search form

SOP for Preventing Contamination in Creams Production

Posted on By

SOP for Preventing Contamination in Creams Production

Standard Operating Procedure for Preventing Contamination in Creams Production

1) Purpose

The purpose of this SOP is to establish procedures for preventing contamination during creams production processes to ensure product quality, safety, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in creams production, including production operators, technicians, quality control (QC) personnel, and maintenance staff. It covers procedures for contamination control from raw material receipt to finished product packaging.

3) Responsibilities

It is the responsibility of production supervisors, QC personnel, maintenance personnel, and all production staff to adhere to this SOP. Production supervisors ensure implementation of contamination prevention measures, QC personnel monitor contamination controls, maintenance staff maintain equipment, and production staff follow contamination control procedures.

See also  SOP for Cleaning Validation in Creams Production

4) Procedure

4.1 Facility Design and Layout

4.1.1 Design production areas with appropriate segregation of operations (e.g., raw material handling, formulation, filling) to prevent cross-contamination.

4.1.2 Ensure adequate space and flow of materials to minimize congestion and contamination risks.

4.1.3 Implement controlled access and airlock systems to prevent unauthorized entry and minimize environmental contamination.

4.2 Cleaning and Sanitization

4.2.1 Develop and implement cleaning and sanitization procedures for all production areas and equipment.

4.2.2 Use approved cleaning agents and disinfectants suitable for creams production equipment and surfaces.

4.2.3 Schedule regular

cleaning activities and maintain cleaning records.

4.3 Personal Hygiene and Gowning

See also  SOP for Water System Maintenance in Creams Production

4.3.1 Establish gowning procedures including wearing of appropriate attire (e.g., uniforms, gloves, hairnets).

4.3.2 Implement hand hygiene protocols, including handwashing and use of hand sanitizers.

4.3.3 Provide training on personal hygiene practices to all personnel involved in creams production.

4.4 Raw Material Handling

4.4.1 Inspect incoming raw materials for signs of contamination or damage.

4.4.2 Store raw materials in designated areas with appropriate environmental controls to prevent contamination.

4.4.3 Ensure proper labeling and segregation of materials to avoid mix-ups and cross-contamination.

4.5 Equipment and Tool Maintenance

4.5.1 Maintain production equipment and tools in good working condition through regular inspection, cleaning, and maintenance.

See also  SOP for Batch Record Review in Creams Production

4.5.2 Calibrate equipment as per schedule and maintain calibration records.

4.5.3 Implement preventive maintenance schedules and promptly address equipment malfunctions or defects.

5) Abbreviations, if any

QC: Quality Control

SOP: Standard Operating Procedure

6) Documents, if any

Cleaning and Sanitization Procedures

Equipment Maintenance and Calibration Records

Training Records on Gowning and Personal Hygiene

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ISO (International Organization for Standardization) 14644: Cleanrooms and associated controlled environments

8) SOP Version

Version 1.0

Creams Tags:Analytical method development for creams, Calibration of cream equipment, Cleaning equipment for creams, Cream homogenization SOP, Cream preparation SOP, Documentation for cream production, Emulsification in creams, Final product inspection for creams, Formulation development for creams, In-process testing for creams, Labeling SOP for creams, Maintaining sterility in creams, Microbial testing in creams, Oil-in-water cream formulation, Packaging SOP for creams, Particle size analysis in creams, pH testing of creams, Pharmaceutical cream manufacturing, Preventing contamination in creams, Process optimization for creams, Process validation for creams, Quality control of creams, Raw material inspection for creams, Rheological testing for creams, Stability testing of creams, Storage conditions for creams, Training SOP for cream production, Viscosity testing for creams, Waste disposal in cream production, Water-in-oil cream process

Post navigation

Previous Post: SOP for Maintaining Sterility in Creams Production
Next Post: SOP for Conducting Process Validation for Creams

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

Read SOPs in your Language:

 - 
Bengali
 - 
bn
English
 - 
en
Gujarati
 - 
gu
Hindi
 - 
hi
Malayalam
 - 
ml
Marathi
 - 
mr
Punjabi
 - 
pa
Tamil
 - 
ta
Telugu
 - 
te

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.

Copyright © 2025 SOP Guide for Pharma.

Powered by PressBook WordPress theme

Go to mobile version