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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 Water for Injection (WFI) System

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SOP for Water for Injection (WFI) System Standard Operating Procedure for Water for Injection (WFI) System 1) Purpose The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Water for Injection (WFI) System used in the manufacturing of ocular dosage forms. 2) Scope This SOP applies to…

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Ocular (Eye) Dosage Forms

SOP for Environmental Monitoring in MDI Production

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SOP for Environmental Monitoring in MDI Production Environmental Monitoring Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for environmental monitoring in metered-dose inhaler (MDI) production to ensure cleanliness, control contamination risks, and maintain compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in environmental…

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Metered-Dose Inhaler

SOP for Pharmacovigilance Risk Management Activities

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SOP for Pharmacovigilance Risk Management Activities Guidelines for Pharmacovigilance Risk Management Activities 1) Purpose The purpose of this SOP is to establish procedures for the identification, assessment, and management of risks associated with pharmaceutical products throughout their lifecycle. 2) Scope This SOP applies to personnel involved in pharmacovigilance risk management, including pharmacovigilance officers, risk managers,…

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Pharmacovigilance

Powder & Granules: SOP for Flowability Testing in Granules

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SOP for Flowability Testing in Granules Standard Operating Procedure for Flowability Testing in Granules 1) Purpose The purpose of this SOP is to outline the procedure for assessing the flowability of granule formulations in the pharmaceutical industry to ensure proper handling and processing. 2) Scope This SOP applies to all personnel involved in flowability testing…

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Powder & Granules

SOP for Gel Mixer Agitator

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SOP for Gel Mixer Agitator Operation and Maintenance of Gel Mixer Agitator 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the gel mixer agitator to ensure effective mixing of gel formulations. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of…

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Vaginal Dosage Forms

SOP for Batch Manufacturing Records (BMR) Preparation

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SOP for Batch Manufacturing Records (BMR) Preparation Standard Operating Procedure for Preparing Batch Manufacturing Records (BMR) 1) Purpose The purpose of this SOP is to establish a procedure for the preparation of Batch Manufacturing Records (BMR) to ensure accurate documentation of the manufacturing process. 2) Scope This SOP applies to all personnel involved in the…

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Rectal Dosage Forms

SOP for Reverse Osmosis System

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SOP for Reverse Osmosis System Standard Operating Procedure for Reverse Osmosis System 1) Purpose The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Reverse Osmosis (RO) System used in the manufacturing of ocular dosage forms. 2) Scope This SOP applies to the Reverse Osmosis (RO) System…

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Ocular (Eye) Dosage Forms

SOP for Cream Heating Mixer

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SOP for Cream Heating Mixer Operation and Maintenance of Cream Heating Mixer 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the cream heating mixer to ensure efficient heating and mixing of cream formulations. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and…

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Vaginal Dosage Forms

SOP for Flowability Testing in Powders

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SOP for Flowability Testing in Powders Standard Operating Procedure for Flowability Testing in Powders 1) Purpose The purpose of this SOP is to outline the procedure for assessing the flowability of powder formulations in the pharmaceutical industry to ensure proper handling and processing. 2) Scope This SOP applies to all personnel involved in flowability testing…

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Powder & Granules

SOP for Deionized Water System

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

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Ocular (Eye) 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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