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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 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

SOP for Conducting Internal Audits in MDI Production

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SOP for Conducting Internal Audits in MDI Production Internal Audit Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for conducting internal audits in metered-dose inhaler (MDI) production to assess compliance with quality management systems, identify areas for improvement, and ensure adherence to regulatory requirements. 2) Scope This SOP…

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Metered-Dose Inhaler

SOP for Tap Density Testing in Granules

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SOP for Tap Density Testing in Granules Standard Operating Procedure for Tap Density Testing in Granules 1) Purpose The purpose of this SOP is to outline the procedure for determining the tap density of granule 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 Ring Storage Unit

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SOP for Ring Storage Unit Operation and Maintenance of Ring Storage Unit 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the ring storage unit to ensure proper storage of rings 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 Pharmacovigilance Medical Device Reporting

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SOP for Pharmacovigilance Medical Device Reporting Guidelines for Pharmacovigilance Medical Device Reporting 1) Purpose The purpose of this SOP is to establish procedures for reporting adverse events associated with medical devices in compliance with regulatory requirements. 2) Scope This SOP applies to personnel involved in pharmacovigilance activities related to medical devices, including pharmacovigilance officers, medical…

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Pharmacovigilance

SOP for Gel Preparation Tank

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

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Ocular (Eye) Dosage Forms

SOP for Packaging Material Receipt and Storage

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SOP for Packaging Material Receipt and Storage Standard Operating Procedure for Receiving and Storing Packaging Materials 1) Purpose The purpose of this SOP is to establish a procedure for the proper receipt and storage of packaging materials to ensure their quality and integrity are maintained. 2) Scope This SOP applies to all packaging materials used…

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Rectal Dosage Forms

SOP for IT Systems Validation and Data Integrity

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SOP for IT Systems Validation and Data Integrity Standard Operating Procedure for IT Systems Validation and Data Integrity 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for the validation and maintenance of information technology (IT) systems used in pharmaceutical manufacturing to ensure data integrity, system reliability, and compliance with…

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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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