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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 Root Cause Analysis of Equipment Failures

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SOP for Root Cause Analysis of Equipment Failures Standard Operating Procedure for Root Cause Analysis of Equipment Failures 1) Purpose The purpose of this SOP is to establish procedures for conducting root cause analysis (RCA) of equipment failures in the manufacturing of dental dosage forms, including pastes, gels, and mouthwashes. The goal is to systematically…

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Dental Dosage Forms

SOP for Peristaltic Pump

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SOP for Peristaltic Pump Standard Operating Procedure for Using Peristaltic Pump 1) Purpose The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the peristaltic pump used in the manufacturing of otic dosage forms to ensure accurate and consistent pumping of liquid products. 2) Scope This SOP applies…

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Otic (Ear) Dosage Forms

SOP for Document Control

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SOP for Document Control Standard Operating Procedure for Document Control 1) Purpose The purpose of this SOP is to establish procedures for the control, distribution, revision, and archiving of documents to ensure accuracy, accessibility, and compliance with regulatory requirements within the organization. 2) Scope This SOP applies to all departments and functions within the organization…

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Rectal Dosage Forms

SOP for Storage System for Finished Products

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SOP for Storage System for Finished Products Standard Operating Procedure for Storage System for Finished Products in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish procedures for the storage of finished products in the pharmaceutical manufacturing facility, ensuring proper inventory management, traceability, and compliance with regulatory requirements. 2) Scope…

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Ocular (Eye) Dosage Forms

SOP for Equipment Hazard Analysis and Critical Control Points (HACCP)

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SOP for Equipment Hazard Analysis and Critical Control Points (HACCP) Standard Operating Procedure for Equipment HACCP in Manufacturing 1) Purpose The purpose of this SOP is to establish procedures for conducting hazard analysis and identifying critical control points (HACCP) for equipment used in the manufacturing of dental dosage forms, including pastes, gels, and mouthwashes. This…

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Dental Dosage Forms

SOP for Crimping Machine

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SOP for Crimping Machine Standard Operating Procedure for Using Crimping Machine 1) Purpose The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the crimping machine used in the manufacturing of otic dosage forms to ensure secure and consistent crimping of containers. 2) Scope This SOP applies to…

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Otic (Ear) Dosage Forms

SOP for Storage System for Raw Materials

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SOP for Storage System for Raw Materials Standard Operating Procedure for Storage System for Raw Materials in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish guidelines for the storage of raw materials used in the manufacturing of ocular dosage forms, ensuring proper inventory management and adherence to regulatory requirements….

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Ocular (Eye) Dosage Forms

SOP for Process Optimization of Manufacturing Equipment

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SOP for Process Optimization of Manufacturing Equipment Standard Operating Procedure for Process Optimization of Manufacturing Equipment 1) Purpose The purpose of this SOP is to establish procedures for optimizing the processes of manufacturing equipment used in the production of dental dosage forms, including pastes, gels, and mouthwashes. The goal is to improve efficiency, reduce costs,…

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Dental Dosage Forms

SOP for Sterilization Line for Inserts

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SOP for Sterilization Line for Inserts Standard Operating Procedure for Sterilization Line for Inserts in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for the operation, cleaning, and maintenance of the sterilization line specifically designed for inserts, ensuring efficient and compliant production practices. 2) Scope This…

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Ocular (Eye) Dosage Forms

SOP for Supplier Qualification and Management

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SOP for Supplier Qualification and Management Standard Operating Procedure for Supplier Qualification and Management 1) Purpose The purpose of this SOP is to establish procedures for the qualification, selection, evaluation, and management of suppliers to ensure a consistent supply of materials and services that meet quality and regulatory requirements. 2) Scope This SOP applies to…

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Rectal Dosage Forms

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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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