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SOP Guide for Pharma

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Tag: Process Validation in Pharma Industry

SOP for Preparing Cleaning Validation Reports

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SOP for Preparing Cleaning Validation Reports Standard Operating Procedure for Preparing Cleaning Validation Reports 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for preparing cleaning validation reports in pharmaceutical manufacturing. This SOP ensures that the results of cleaning validation activities are documented in a comprehensive and structured manner….

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Validations and Qualifications

SOP for Documenting IQ/OQ/PQ Activities

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SOP for Documenting IQ/OQ/PQ Activities Standard Operating Procedure for Documenting IQ/OQ/PQ Activities 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the process for documenting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities in pharmaceutical manufacturing. This SOP ensures that IQ, OQ, and PQ activities are properly documented…

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Validations and Qualifications

SOP for Documentation of Process Validation Studies

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SOP for Documentation of Process Validation Studies Standard Operating Procedure for Documentation of Process Validation Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for documenting process validation studies conducted during pharmaceutical manufacturing. This SOP ensures that all process validation activities are thoroughly documented, providing a clear and…

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Validations and Qualifications

SOP for Preparing Validation Master Plan (VMP)

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SOP for Preparing Validation Master Plan (VMP) Standard Operating Procedure for Preparing Validation Master Plan (VMP) 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for preparing a Validation Master Plan (VMP) for pharmaceutical manufacturing. This SOP ensures that a comprehensive and systematic approach is taken in planning, conducting,…

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Validations and Qualifications

SOP for Preparing Validation Protocols and Reports

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SOP for Preparing Validation Protocols and Reports Standard Operating Procedure for Preparing Validation Protocols and Reports 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for preparing validation protocols and reports in pharmaceutical manufacturing. This SOP ensures that validation activities, including process validation, cleaning validation, and equipment qualification, are…

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Validations and Qualifications

SOP for Sampling Procedures for Cleaning Validation

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SOP for Sampling Procedures for Cleaning Validation Standard Operating Procedure for Sampling Procedures for Cleaning Validation 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for sampling during cleaning validation activities. The objective is to ensure that the cleaning processes used in pharmaceutical manufacturing equipment effectively remove residues of…

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Validations and Qualifications

SOP for Cleaning Validation of Vacuum Systems for Solids

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SOP for Cleaning Validation of Vacuum Systems for Solids Standard Operating Procedure for Cleaning Validation of Vacuum Systems for Solids 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for performing cleaning validation of vacuum systems used in the pharmaceutical manufacturing process, specifically for handling solids. This SOP ensures…

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Validations and Qualifications

SOP for Cleaning Validation of Filter Assemblies

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SOP for Cleaning Validation of Filter Assemblies Standard Operating Procedure for Cleaning Validation of Filter Assemblies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for performing cleaning validation of filter assemblies 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 Validating Detergents and Cleaning Agents

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SOP for Validating Detergents and Cleaning Agents Standard Operating Procedure for Validating Detergents and Cleaning Agents 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for validating detergents and cleaning agents used in pharmaceutical manufacturing. This SOP ensures that detergents and cleaning agents are properly validated to confirm their…

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Validations and Qualifications

SOP for Cleaning Validation of Ampoule Filling Machines

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

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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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