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SOP Guide for Pharma

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SOP for Labeling of Aerosols

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SOP for Labeling of Aerosols

Standard Operating Procedure for Labeling of Aerosol Products

1) Purpose

The purpose of this SOP is to outline the procedures for labeling aerosol products in the pharmaceutical industry, ensuring accurate labeling, compliance with regulatory requirements, and clear identification of product information.

2) Scope

This SOP applies to the labeling department at [Company Name], responsible for labeling aerosol products before distribution and ensuring adherence to labeling guidelines.

3) Responsibilities

Labeling Supervisor: Oversees labeling operations and ensures adherence to SOP.
Labeling Operators: Responsible for applying labels accurately and verifying label information.
Quality Control (QC) Personnel: Conducts checks to ensure label accuracy and compliance.

See also  SOP for Technology Transfer in Aerosol Production

4) Procedure

4.1 Label Preparation:
4.1.1 Verify the availability and correctness of labels for each batch.
4.1.2 Ensure labels are stored in a controlled environment to prevent damage or mix-up.

4.2 Label Application:
4.2.1 Clean and prepare aerosol containers for labeling.
4.2.2 Apply labels to containers using automated or manual labeling equipment.
4.2.3 Verify correct placement, alignment, and adherence of labels.

4.3 Verification of Label Information:
4.3.1 Check label information including product name, strength, batch number, and expiry date.
4.3.2 Ensure all required regulatory information is included as per guidelines.

4.4 Inspection and Quality Checks:
4.4.1 Conduct visual inspection of labeled aerosol containers for label uniformity

and integrity.
4.4.2 Perform random checks to verify label accuracy and readability.

See also  SOP for Freeze-Thaw Stability Testing for Aerosols

4.5 Documentation:
4.5.1 Record label application details and any deviations encountered.
4.5.2 Document label inspections and approvals in the batch record.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Labeling Records
Batch Manufacturing Record (BMR)

7) Reference, if any

FDA Labeling Requirements
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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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