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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Tag: Temperature mapping in storage areas

SOP for Handling of Rejected Vials

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SOP for Handling of Rejected Vials Standard Operating Procedure for Handling of Rejected Vials 1) Purpose The purpose of this SOP is to define the procedures for handling and disposing of rejected vials to prevent contamination and ensure regulatory compliance. 2) Scope This SOP applies to all personnel involved in handling rejected vials at [Company…

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Injectables

SOP for Inspection of Filled Vials

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SOP for Inspection of Filled Vials Standard Operating Procedure for Inspection of Filled Vials 1) Purpose The purpose of this SOP is to define the procedures for inspecting filled vials to ensure they meet quality and sterility standards before release. 2) Scope This SOP applies to all personnel involved in the inspection of filled vials…

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Injectables

SOP for Labeling of Vials

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SOP for Labeling of Vials Standard Operating Procedure for Labeling of Vials 1) Purpose The purpose of this SOP is to establish procedures for the accurate and consistent labeling of vials to ensure correct identification and traceability of injection products. 2) Scope This SOP applies to all personnel involved in the labeling of vials at…

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Injectables

SOP for Sealing and Capping of Vials

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SOP for Sealing and Capping of Vials Standard Operating Procedure for Sealing and Capping of Vials 1) Purpose The purpose of this SOP is to define the procedures for sealing and capping vials to ensure the integrity and sterility of injection products. 2) Scope This SOP applies to all personnel involved in sealing and capping…

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Injectables

Injectables: SOP for Lyophilization Process

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SOP for Lyophilization Process Standard Operating Procedure for Lyophilization Process 1) Purpose The purpose of this SOP is to define the procedures for the lyophilization (freeze-drying) process to ensure the stability and sterility of injection products. 2) Scope This SOP applies to all personnel involved in the lyophilization process at [Company Name] for the production…

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Injectables

SOP for Filling Machine Operation

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SOP for Filling Machine Operation Standard Operating Procedure for Filling Machine Operation 1) Purpose The purpose of this SOP is to outline the procedures for operating the filling machine to ensure accurate and sterile filling of injection products. 2) Scope This SOP applies to all personnel involved in operating the filling machine at [Company Name]…

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Injectables

SOP for Aseptic Processing

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SOP for Aseptic Processing Standard Operating Procedure for Aseptic Processing 1) Purpose The purpose of this SOP is to establish procedures for aseptic processing to ensure that the manufacturing of injection products is performed in a sterile environment, preventing contamination. 2) Scope This SOP applies to all personnel involved in aseptic processing at [Company Name]…

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Injectables

SOP for Filtration of Solutions

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SOP for Filtration of Solutions Standard Operating Procedure for Filtration of Solutions 1) Purpose The purpose of this SOP is to define the procedures for the filtration of solutions to ensure they are free of particulates and contaminants, and suitable for use in the manufacturing of injection products. 2) Scope This SOP applies to all…

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Injectables

SOP for Preparation of Solutions

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SOP for Preparation of Solutions Standard Operating Procedure for Preparation of Solutions 1) Purpose The purpose of this SOP is to outline the procedures for the preparation of solutions to ensure their quality and consistency for use in the manufacturing of injection products. 2) Scope This SOP applies to all personnel involved in the preparation…

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Injectables

SOP for Sterilization of Manufacturing Equipment

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SOP for Sterilization of Manufacturing Equipment Standard Operating Procedure for Sterilization of Manufacturing Equipment 1) Purpose The purpose of this SOP is to define the procedures for sterilizing manufacturing equipment to ensure a sterile production environment and prevent contamination of injection products. 2) Scope This SOP applies to all personnel involved in the sterilization of…

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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
  • 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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