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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 Tablet Compression Machine

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SOP for Tablet Compression Machine Operation and Maintenance of Tablet Compression Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the tablet compression machine to ensure efficient and accurate compression of tablet formulations. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and…

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Vaginal Dosage Forms

SOP for Cleaning of Equipment Used for MDIs

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SOP for Cleaning of Equipment Used for MDIs Equipment Cleaning Procedures for MDIs 1) Purpose The purpose of this SOP is to outline the procedures for cleaning and sanitizing equipment used in the manufacturing of metered-dose inhalers (MDIs) to prevent cross-contamination, ensure product quality, and comply with regulatory requirements. 2) Scope This SOP applies to…

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Metered-Dose Inhaler

SOP for Cleaning of Equipment Used for Granules

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SOP for Cleaning of Equipment Used for Granules Standard Operating Procedure for Cleaning of Equipment Used for Granules 1) Purpose The purpose of this SOP is to provide a standardized procedure for the cleaning of equipment used in the manufacturing of granules in the pharmaceutical industry to prevent cross-contamination and ensure product quality. 2) Scope…

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Powder & Granules

SOP for Ring Drying Oven

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SOP for Ring Drying Oven Operation and Maintenance of Ring Drying Oven 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the ring drying oven to ensure thorough drying of rings during manufacturing. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance…

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Vaginal Dosage Forms

SOP for Pharmacovigilance Safety Data Monitoring Boards (DSMB)

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SOP for Pharmacovigilance Safety Data Monitoring Boards (DSMB) Guidelines for Pharmacovigilance Safety Data Monitoring Boards (DSMB) 1) Purpose The purpose of this SOP is to establish procedures for the operation and responsibilities of Safety Data Monitoring Boards (DSMBs) in pharmacovigilance. 2) Scope This SOP applies to DSMB members, pharmacovigilance personnel, and other stakeholders involved in…

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Pharmacovigilance

SOP for Stability Testing of Granules

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SOP for Stability Testing of Granules Standard Operating Procedure for Stability Testing of Granules 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability testing of granules in the pharmaceutical manufacturing process to assess their shelf-life under various storage conditions. 2) Scope This SOP applies to all personnel involved…

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Powder & Granules

SOP for Suppository Inspection Machine

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SOP for Suppository Inspection Machine Operation and Maintenance of Suppository Inspection Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the suppository inspection machine to ensure thorough inspection of suppositories for quality control purposes. 2) Scope This SOP applies to all personnel involved in the operation, cleaning,…

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Vaginal Dosage Forms

SOP for Storage Conditions of MDIs

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SOP for Storage Conditions of MDIs MDI Storage Conditions Procedures 1) Purpose The purpose of this SOP is to define the procedures for the storage of metered-dose inhalers (MDIs) to ensure product stability, integrity, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the storage of MDIs at the…

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Metered-Dose Inhaler

SOP for Monitoring and Controlling Temperature and Humidity in Storage Areas

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SOP for Monitoring and Controlling Temperature and Humidity in Storage Areas Standard Operating Procedure for Monitoring and Controlling Temperature and Humidity in Storage Areas 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for monitoring and controlling temperature and humidity in storage areas within the pharmaceutical manufacturing facility to…

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Injectables

SOP for Ring Packaging Machine

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SOP for Ring Packaging Machine Operation and Maintenance of Ring Packaging Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the ring packaging machine to ensure efficient and accurate packaging of rings. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance…

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Vaginal 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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