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Tag: Prospective Validation in Pharma

SOP for Cleaning Validation of Sterile Manufacturing Equipment

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SOP for Cleaning Validation of Sterile Manufacturing Equipment Standard Operating Procedure for Cleaning Validation of Sterile Manufacturing Equipment 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for performing cleaning validation of sterile manufacturing equipment used in pharmaceutical manufacturing. This SOP ensures that cleaning procedures are validated to effectively…

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Validations and Qualifications

SOP for Cleaning Validation of Liquid Filling Equipment

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SOP for Cleaning Validation of Liquid Filling Equipment Standard Operating Procedure for Cleaning Validation of Liquid Filling Equipment 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for performing cleaning validation of liquid filling equipment used in pharmaceutical manufacturing. This SOP ensures that cleaning procedures are validated to effectively…

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Validations and Qualifications

SOP for Cleaning Validation of Coating Pans

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SOP for Cleaning Validation of Coating Pans Standard Operating Procedure for Cleaning Validation of Coating Pans 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for performing cleaning validation of coating pans used in pharmaceutical manufacturing. This SOP ensures that cleaning procedures are validated to effectively remove residues of…

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Validations and Qualifications

SOP for Cleaning Validation of Granulators

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SOP for Cleaning Validation of Granulators Standard Operating Procedure for Cleaning Validation of Granulators 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for performing cleaning validation of granulators used in pharmaceutical manufacturing. This SOP ensures that cleaning procedures are properly validated to remove residues of active pharmaceutical ingredients…

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Validations and Qualifications

SOP for Cleaning Validation of Tablet Compression Machines

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SOP for Cleaning Validation of Tablet Compression Machines Standard Operating Procedure for Cleaning Validation of Tablet Compression Machines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the cleaning validation process for tablet compression machines used in pharmaceutical manufacturing. This SOP ensures that tablet compression machines are thoroughly cleaned between production…

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Validations and Qualifications

SOP for Qualification of Chillers and Cold Storage Units

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SOP for Qualification of Chillers and Cold Storage Units Standard Operating Procedure for Qualification of Chillers and Cold Storage Units 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying chillers and cold storage units used in pharmaceutical manufacturing and storage areas. This SOP ensures that the chillers…

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Validations and Qualifications

SOP for Qualification of Boilers for Steam Generation

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SOP for Qualification of Boilers for Steam Generation Standard Operating Procedure for Qualification of Boilers for Steam Generation 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying boilers used for steam generation in pharmaceutical manufacturing. This SOP ensures that the boilers are correctly installed, calibrated, and operate…

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Validations and Qualifications

SOP for IQ/OQ/PQ of Water Purification Systems (RO, WFI)

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SOP for IQ/OQ/PQ of Water Purification Systems (RO, WFI) Standard Operating Procedure for IQ/OQ/PQ of Water Purification Systems (RO, WFI) 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying Water Purification Systems, including Reverse Osmosis (RO) and Water for Injection (WFI) systems, used in pharmaceutical manufacturing. This…

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Validations and Qualifications

SOP for Qualification of Air Compressors in Manufacturing Units

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SOP for Qualification of Air Compressors in Manufacturing Units Standard Operating Procedure for Qualification of Air Compressors in Manufacturing Units 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying air compressors used in pharmaceutical manufacturing units. This SOP ensures that the air compressors are correctly installed, calibrated,…

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Validations and Qualifications

SOP for Qualification of HVAC Systems for Non-Sterile Areas

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SOP for Qualification of HVAC Systems for Non-Sterile Areas Standard Operating Procedure for Qualification of HVAC Systems for Non-Sterile Areas 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying Heating, Ventilation, and Air Conditioning (HVAC) systems used in non-sterile areas within pharmaceutical manufacturing environments. This SOP ensures…

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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
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers 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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