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SOP for Packaging of Aerosols

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SOP for Packaging of Aerosols

Standard Operating Procedure for Packaging of Aerosol Products

1) Purpose

The purpose of this SOP is to provide guidelines for the packaging of aerosol products in the pharmaceutical industry, ensuring proper handling, labeling, and quality checks during packaging.

2) Scope

This SOP applies to the packaging department at [Company Name], responsible for packaging aerosol products in compliance with regulatory requirements and company standards.

3) Responsibilities

Packaging Supervisor: Oversees all packaging operations and ensures adherence to SOP.
Packaging Operators: Responsible for performing packaging tasks as per SOP.
Quality Assurance (QA) Personnel: Conducts checks and verifies packaging integrity.

See also  SOP for Use of Propellants in Aerosol Production

4) Procedure

4.1 Preparation of Packaging Materials:
4.1.1 Ensure all packaging materials are clean, inspected, and approved for use.
4.1.2 Verify the availability of labels, leaflets, and other necessary components.

4.2 Inspection and Line Setup:
4.2.1 Inspect the packaging line for cleanliness and functionality.
4.2.2 Set up the packaging line according to the batch specifications.

4.3 Loading of Aerosol Containers:
4.3.1 Ensure containers are loaded into the packaging equipment correctly.
4.3.2 Verify the correct orientation and alignment of containers.

4.4 Labeling and Printing:
4.4.1 Apply labels to containers using automated labeling equipment.
4.4.2 Verify label accuracy, including batch number, expiry date, and product information.

See also  SOP for Microbial Limits Testing for Aerosols

4.5 Leaflet Insertion:
4.5.1 Insert leaflets or instruction

sheets into packaging as required.
4.5.2 Ensure correct placement and orientation of leaflets.

4.6 Cartoning and Batch Coding:
4.6.1 Place packaged aerosols into cartons or boxes.
4.6.2 Apply batch coding and ensure traceability of each packaged unit.

4.7 Inspection and Quality Checks:
4.7.1 Perform visual inspection of packaged aerosols for defects or damage.
4.7.2 Conduct weight checks and ensure compliance with fill weight specifications.

4.8 Final Packaging and Sealing:
4.8.1 Seal cartons securely and ensure tamper-evident features are intact.
4.8.2 Prepare packaged products for storage or distribution.

5) Abbreviations, if any

QA: Quality Assurance
SOP: Standard Operating Procedure

See also  SOP for Foreign Particulate Matter Testing in Aerosols

6) Documents, if any

Packaging Records
Packaging Line Setup Checklist

7) Reference, if any

FDA Packaging Guidelines
ICH Q9: Quality Risk Management

8) SOP Version

Version 1.0

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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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