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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Tag: Performance Qualification in Pharma

SOP for Validation of Secondary Packaging Processes

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SOP for Validation of Secondary Packaging Processes Standard Operating Procedure for Validating Secondary Packaging Processes 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for validating secondary packaging operations in pharmaceutical manufacturing. This SOP ensures that the secondary packaging process, which involves packaging of the final product into outer…

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Validations and Qualifications

SOP for Process Validation of Spray Drying Techniques

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SOP for Process Validation of Spray Drying Techniques Standard Operating Procedure for Validating Spray Drying Techniques 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for validating spray drying techniques in the manufacturing of pharmaceutical products. This SOP ensures that the spray drying process is carried out effectively and…

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Validations and Qualifications

SOP for Validation of Powder Dispensing Processes

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SOP for Validation of Powder Dispensing Processes Standard Operating Procedure for Validating Powder Dispensing Processes 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for validating the powder dispensing operations in pharmaceutical manufacturing. This SOP ensures that the powder dispensing process is performed accurately and consistently, meeting product specifications…

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Validations and Qualifications

SOP for Process Validation of Heat-Sealing Operations

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SOP for Process Validation of Heat-Sealing Operations Standard Operating Procedure for Validating Heat-Sealing Operations 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for validating heat-sealing operations in the packaging of pharmaceutical products, ensuring the integrity, safety, and compliance of heat-sealed packages. This SOP ensures that the heat-sealing process…

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Validations and Qualifications

SOP for Validation of Freeze-Drying Process for Lyophilized Products

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SOP for Validation of Freeze-Drying Process for Lyophilized Products Standard Operating Procedure for Validating Freeze-Drying Process for Lyophilized Products 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for validating the freeze-drying (lyophilization) process used in the manufacturing of lyophilized pharmaceutical products. This SOP ensures that the freeze-drying process…

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Validations and Qualifications

SOP for Validation of Sachet Filling for Granules

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SOP for Validation of Sachet Filling for Granules Standard Operating Procedure for Validating Sachet Filling for Granules 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a standardized approach for validating the sachet filling process for granules in pharmaceutical manufacturing. This SOP ensures that the sachet filling process consistently meets product…

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Validations and Qualifications

SOP for Validation of Stick Pack Filling for Oral Powders

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SOP for Validation of Stick Pack Filling for Oral Powders Standard Operating Procedure for Validating Stick Pack Filling for Oral Powders 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for validating the stick pack filling operation for oral powders in pharmaceutical manufacturing. This SOP ensures that the stick…

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Validations and Qualifications

SOP for Validation of Ampoule Sealing Processes

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SOP for Validation of Ampoule Sealing Processes Standard Operating Procedure for Validating Ampoule Sealing Processes 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for validating ampoule sealing operations in the manufacturing of injectable pharmaceutical products. This SOP ensures that ampoule sealing processes are conducted in a controlled and…

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Validations and Qualifications

SOP for Validation of Bottle Filling and Capping for Liquids

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SOP for Validation of Bottle Filling and Capping for Liquids Standard Operating Procedure for Validating Bottle Filling and Capping for Liquids 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the steps required for validating the bottle filling and capping processes for liquid pharmaceutical products. This SOP ensures that the filling…

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Validations and Qualifications

SOP for Validation of Blister Packaging Operations

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SOP for Validation of Blister Packaging Operations Standard Operating Procedure for Validating Blister Packaging Operations 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for validating blister packaging operations for pharmaceutical products, including tablets, capsules, and other solid dosage forms. The validation ensures that the blister packaging process consistently…

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Validations and Qualifications

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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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