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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOPs for Injectables

SOP for External Audits by Regulatory Bodies

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The purpose of this SOP is to establish procedures for preparing, conducting, and responding to external audits by regulatory bodies to ensure compliance with regulatory requirements and maintain certifications.
Click to read the full article.

Injectables

SOP for Internal Audits of Manufacturing Processes

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The purpose of this SOP is to outline procedures for conducting internal audits of manufacturing processes to verify compliance with regulatory requirements, identify areas for improvement, and ensure consistent product quality.
Click to read the full article.

Injectables

SOP for Handling and Disposal of Waste Materials from FFS Machine

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The purpose of this SOP is to establish procedures for the safe handling, segregation, and disposal of waste materials generated from the Form-Fill-Seal (FFS) machine operations to ensure environmental protection and regulatory compliance.
Click to read the full article.

Injectables

SOP for Sample Collection during FFS Operations

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The purpose of this SOP is to define procedures for collecting representative samples during Form-Fill-Seal (FFS) operations to ensure product quality and compliance with regulatory requirements.
Click to read the full article.

Injectables

SOP for Cleaning Between Batch Runs

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The purpose of this SOP is to establish procedures for cleaning equipment and manufacturing areas between batch runs to prevent cross-contamination, ensure product quality, and maintain compliance with regulatory requirements.
Click to read the full article.

Injectables

SOP for Seal Integrity and Leak Testing

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The purpose of this SOP is to establish procedures for testing the seal integrity and leakage of packaging for pharmaceutical products to ensure product sterility and quality.
Click to read the full article.

Injectables

SOP for Filling Accuracy and Volume Checks

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The purpose of this SOP is to outline procedures for verifying the accuracy and volume of filled products during pharmaceutical manufacturing to ensure compliance with specifications and regulatory requirements.
Click to read the full article.

Injectables

SOP for Emergency Shutdown and Restart Procedures

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The purpose of this SOP is to define the steps and protocols for safely shutting down and restarting manufacturing equipment in case of emergencies to protect personnel and minimize equipment damage.
Click to read the full article.

Injectables

SOP for Start-Up and Shutdown Procedures for FFS Machine

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The purpose of this SOP is to establish guidelines for the safe and efficient start-up and shutdown of the Form-Fill-Seal (FFS) machine to ensure consistent production and equipment longevity.
Click to read the full article.

Injectables

SOP for Setting Parameters for Different IV Solutions

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The purpose of this SOP is to define the procedures for setting and adjusting parameters on manufacturing equipment for different intravenous (IV) solutions to ensure product quality and consistency.
Click to read the full article.

Injectables

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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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