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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 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

SOP for Process Analytical Technology (PAT) Implementation

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SOP for Process Analytical Technology (PAT) Implementation Standard Operating Procedure for Process Analytical Technology (PAT) Implementation 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for the implementation of Process Analytical Technology (PAT) in pharmaceutical manufacturing processes to enhance process understanding, control, and efficiency. 2) Scope This SOP applies to…

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Injectables

SOP for Change Control in MDI Production

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SOP for Change Control in MDI Production Change Control Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for change control in metered-dose inhaler (MDI) production to manage and document changes to processes, equipment, facilities, and systems in a controlled manner to ensure product quality, safety, and efficacy. 2)…

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Metered-Dose Inhaler

SOP for Pharmacovigilance Safety Signal Investigation

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SOP for Pharmacovigilance Safety Signal Investigation Guidelines for Pharmacovigilance Safety Signal Investigation 1) Purpose The purpose of this SOP is to outline procedures for the investigation and evaluation of safety signals identified during pharmacovigilance activities. 2) Scope This SOP applies to personnel involved in pharmacovigilance signal detection, including pharmacovigilance officers, safety scientists, medical reviewers, and…

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Pharmacovigilance

SOP for Tablet Inspection Conveyor

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SOP for Tablet Inspection Conveyor Operation and Maintenance of Tablet Inspection Conveyor 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the tablet inspection conveyor to ensure accurate inspection of tablets 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 Eye Drop Preparation Tank

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

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Ocular (Eye) Dosage Forms

Powder & Granules: 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 Packaging Material Sampling and Testing

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SOP for Packaging Material Sampling and Testing Standard Operating Procedure for Sampling and Testing Packaging Materials 1) Purpose The purpose of this SOP is to establish a procedure for the sampling and testing of packaging materials to ensure they meet specified quality standards before use in manufacturing. 2) Scope This SOP applies to all packaging…

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Rectal Dosage Forms

SOP for Suppository Packaging Conveyor

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SOP for Suppository Packaging Conveyor Operation and Maintenance of Suppository Packaging Conveyor 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the suppository packaging conveyor to ensure efficient packaging of suppositories. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the…

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Vaginal Dosage Forms

SOP for Ointment Preparation Tank

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