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SOP for Quality Control Testing of Aerosols

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SOP for Quality Control Testing of Aerosols

Standard Operating Procedure for Quality Control Testing of Aerosol Products

1) Purpose

The purpose of this SOP is to define the procedures for conducting quality control testing on aerosol products to ensure they meet regulatory requirements and internal quality standards.

2) Scope

This SOP applies to the Quality Control (QC) department at [Company Name], responsible for testing aerosol products at various stages of production and before release.

3) Responsibilities

QC Manager: Oversees all QC testing activities and ensures compliance.
QC Analysts: Perform tests and record results accurately.
Production Personnel: Provide samples and cooperate during testing procedures.

See also  SOP for Formulation Development for Aerosols

4) Procedure

4.1 Sampling:
4.1.1 Collect representative samples from each batch of aerosol products.
4.1.2 Ensure samples are labeled with batch number, date, and other relevant information.

4.2 Physical Tests:
4.2.1 Conduct tests for appearance, color, and clarity.
4.2.2 Measure fill weight and ensure it meets specified limits.
4.2.3 Perform leak testing using appropriate methods.

4.3 Chemical Tests:
4.3.1 Analyze the formulation for active ingredient content using validated methods.
4.3.2 Test for propellant content and ensure it is within acceptable limits.
4.3.3 Conduct pH testing and other chemical attributes as required.

4.4 Microbiological Tests:
4.4.1 Perform microbial limits testing to ensure product safety.
4.4.2 Conduct sterility testing for aseptic

aerosol products.

See also  SOP for Label Inspection for Aerosols

4.5 Performance Testing:
4.5.1 Evaluate spray pattern, plume geometry, and spray force.
4.5.2 Assess content uniformity across samples.

4.6 Documentation:
4.6.1 Record all test results accurately in the QC test report.
4.6.2 Document any deviations or out-of-specification (OOS) results.

5) Abbreviations, if any

QC: Quality Control
OOS: Out of Specification

6) Documents, if any

QC Test Report
Batch Manufacturing Record (BMR)

7) Reference, if any

USP , Pharmacopeial Forum, etc. (Specific references as per regulatory guidelines)

8) SOP Version

Version 1.0

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Next Post: SOP for Vendor Qualification for Maintenance Services

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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