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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Author: Auditor

SOP for Vial Filling Machine

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SOP for Vial Filling Machine Standard Operating Procedure for Vial Filling Machine Operation 1) Purpose The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Vial Filling Machine used in the manufacturing of ocular dosage forms. 2) Scope This SOP applies to the Vial Filling Machine used…

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Ocular (Eye) Dosage Forms

SOP for Gel Storage Tank Agitator

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SOP for Gel Storage Tank Agitator Operation and Maintenance of Gel Storage Tank Agitator 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the gel storage tank agitator to ensure proper mixing and storage of gel during the manufacturing process. 2) Scope This SOP applies to all personnel…

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Vaginal Dosage Forms

SOP for Bulk Density Testing in Powders

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SOP for Bulk Density Testing in Powders Standard Operating Procedure for Bulk Density Testing in Powders 1) Purpose The purpose of this SOP is to outline the procedure for determining the bulk density of powder formulations in the pharmaceutical industry to ensure consistency and quality. 2) Scope This SOP applies to all personnel involved in…

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Powder & Granules

SOP for Pharmacovigilance Database Query Management

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SOP for Pharmacovigilance Database Query Management Guidelines for Pharmacovigilance Database Query Management 1) Purpose The purpose of this SOP is to establish procedures for managing queries in the pharmacovigilance database to ensure accurate and timely data retrieval for safety assessment and regulatory reporting. 2) Scope This SOP applies to personnel responsible for querying pharmacovigilance databases,…

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Pharmacovigilance

Ocular (Eye) Dosage Forms: SOP for Tube Filling Machine

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SOP for Tube Filling Machine Standard Operating Procedure for Tube Filling Machine Operation 1) Purpose The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Tube Filling Machine used in the manufacturing of ocular dosage forms. 2) Scope This SOP applies to the Tube Filling Machine used…

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Ocular (Eye) Dosage Forms

SOP for Cream Dispensing Pump

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SOP for Cream Dispensing Pump Operation and Maintenance of Cream Dispensing Pump 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the cream dispensing pump to ensure accurate dispensing of cream during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the operation, cleaning,…

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Vaginal Dosage Forms

SOP for Cleaning and Sanitation of Manufacturing Areas

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SOP for Cleaning and Sanitation of Manufacturing Areas Standard Operating Procedure for Cleaning and Sanitizing Manufacturing Areas 1) Purpose The purpose of this SOP is to establish a procedure for the cleaning and sanitation of manufacturing areas to ensure a contamination-free environment and compliance with GMP standards. 2) Scope This SOP applies to all manufacturing,…

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Rectal Dosage Forms

SOP for Equipment Troubleshooting in MDI Production

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SOP for Equipment Troubleshooting in MDI Production Equipment Troubleshooting Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for troubleshooting equipment issues in metered-dose inhaler (MDI) production to minimize downtime, ensure production efficiency, and maintain product quality. 2) Scope This SOP applies to all personnel involved in equipment troubleshooting…

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Metered-Dose Inhaler

SOP for Particle Size Distribution in Granules

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SOP for Particle Size Distribution in Granules Standard Operating Procedure for Particle Size Distribution in Granules 1) Purpose The purpose of this SOP is to outline the procedure for determining the particle size distribution of granule formulations in the pharmaceutical industry to ensure uniformity and quality. 2) Scope This SOP applies to all personnel involved…

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Powder & Granules

Injectables: SOP for Requalification of Equipment and Systems

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SOP for Requalification of Equipment and Systems Standard Operating Procedure for Requalification of Equipment and Systems 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for the requalification of equipment, utilities, facilities, and systems within the pharmaceutical manufacturing facility to ensure continued compliance with regulatory requirements and consistent product quality….

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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
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Capsules V 2.0
  • Creams 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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