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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 Ointment Preparation System

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SOP for Ointment Preparation System Standard Operating Procedure for Ointment Preparation System in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for the operation, cleaning, and maintenance of the ointment preparation system to ensure the consistent and safe production of ocular ointments in compliance with regulatory…

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Ocular (Eye) Dosage Forms

SOP for Stability Testing

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SOP for Stability Testing Guidelines for Conducting Stability Testing on Vaginal Dosage Forms 1) Purpose The purpose of this SOP is to outline the procedures for conducting stability testing on vaginal dosage forms to ensure they maintain their quality, safety, and efficacy throughout their shelf life. 2) Scope This SOP applies to all personnel involved…

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Vaginal Dosage Forms

SOP for Equipment Shutdown and Restart Procedures

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SOP for Equipment Shutdown and Restart Procedures Standard Operating Procedure for Equipment Shutdown and Restart Procedures 1) Purpose The purpose of this SOP is to establish procedures for the safe and efficient shutdown and restart of equipment used in the manufacturing of dental dosage forms to prevent damage and ensure operational readiness. 2) Scope This…

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Dental Dosage Forms

SOP for Handling of Complaints

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SOP for Handling of Complaints Standard Operating Procedure for Handling of Complaints 1) Purpose The purpose of this SOP is to establish procedures for the receipt, evaluation, investigation, and resolution of product complaints to ensure customer satisfaction and compliance with regulatory requirements. 2) Scope This SOP applies to all complaints received by the manufacturing facility…

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Rectal Dosage Forms

SOP for Gel Preparation System

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SOP for Gel Preparation System Standard Operating Procedure for Gel Preparation System in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for the operation, cleaning, and maintenance of the gel preparation system to ensure the consistent and safe production of ocular gels in compliance with regulatory…

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Ocular (Eye) Dosage Forms

SOP for Batch Manufacturing Record for Granules

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SOP for Batch Manufacturing Record for Granules Standard Operating Procedure for Batch Manufacturing Record for Granules 1) Purpose The purpose of this SOP is to provide guidelines for documenting and maintaining batch manufacturing records (BMR) for granules in the pharmaceutical industry to ensure traceability, consistency, and compliance with regulatory requirements. 2) Scope This SOP applies…

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Powder & Granules

SOP for Finished Product Testing and Release

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SOP for Finished Product Testing and Release Guidelines for Testing and Release of Finished Vaginal Dosage Forms 1) Purpose The purpose of this SOP is to outline the procedures for testing and releasing finished vaginal dosage forms to ensure that they meet specified quality standards before distribution. 2) Scope This SOP applies to all personnel…

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Vaginal Dosage Forms

SOP for Finished Product Sampling

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SOP for Finished Product Sampling Guidelines for Sampling of Finished Vaginal Dosage Forms 1) Purpose The purpose of this SOP is to establish a procedure for the sampling of finished vaginal dosage forms to ensure that the samples taken are representative of the batch and comply with quality standards. 2) Scope This SOP applies to…

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Vaginal Dosage Forms

Dental Dosage Forms: SOP for Changeover Procedures Between Batches

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SOP for Changeover Procedures Between Batches Standard Operating Procedure for Changeover Procedures Between Batches 1) Purpose The purpose of this SOP is to establish procedures for the efficient and effective changeover of equipment between batches during the manufacturing of dental dosage forms to prevent cross-contamination and ensure product quality. 2) Scope This SOP applies to…

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Dental Dosage Forms

SOP for Batch Manufacturing Record for Powders

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SOP for Batch Manufacturing Record for Powders Standard Operating Procedure for Batch Manufacturing Record for Powders 1) Purpose The purpose of this SOP is to provide guidelines for documenting and maintaining batch manufacturing records (BMR) for powders in the pharmaceutical industry to ensure traceability, consistency, and compliance with regulatory requirements. 2) Scope This SOP applies…

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Powder & Granules

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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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