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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Tag: Quality Risk Management SOP

SOP for Equipment Cleaning Verification

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SOP for Equipment Cleaning Verification Standard Operating Procedure for Equipment Cleaning Verification 1) Purpose This SOP outlines the procedures for verifying the cleaning of pharmaceutical equipment to ensure it meets cleanliness standards and prevents cross-contamination. 2) Scope This SOP applies to all pharmaceutical manufacturing areas where equipment cleaning verification is critical to maintaining product quality…

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Quality Assurance

SOP for Vibration Monitoring

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SOP for Vibration Monitoring Standard Operating Procedure for Vibration Monitoring 1) Purpose This SOP outlines the procedures for monitoring vibration levels in pharmaceutical manufacturing areas to ensure equipment reliability, product quality, and compliance with regulatory requirements. 2) Scope This SOP applies to all areas within the pharmaceutical facility where vibration monitoring is critical to maintaining…

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Quality Assurance

SOP for Light and UV Monitoring

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SOP for Light and UV Monitoring Standard Operating Procedure for Light and UV Monitoring 1) Purpose This SOP outlines the procedures for monitoring light and ultraviolet (UV) radiation levels in pharmaceutical manufacturing areas to ensure product stability and compliance with regulatory requirements. 2) Scope This SOP applies to all areas within the pharmaceutical facility where…

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Quality Assurance

SOP for Temperature and Humidity Monitoring

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SOP for Temperature and Humidity Monitoring Standard Operating Procedure for Temperature and Humidity Monitoring 1) Purpose This SOP outlines the procedures for monitoring temperature and humidity levels in pharmaceutical manufacturing and storage areas to ensure product quality and compliance with regulatory requirements. 2) Scope This SOP applies to all areas within the pharmaceutical facility where…

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Quality Assurance

Quality Assurance: SOP for Pest Control

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SOP for Pest Control Standard Operating Procedure for Pest Control 1) Purpose This SOP outlines the procedures for implementing effective pest control measures in pharmaceutical manufacturing facilities to prevent pest infestations and ensure compliance with regulatory standards. 2) Scope This SOP applies to all areas within the pharmaceutical manufacturing facility where pest control measures are…

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Quality Assurance

Quality Assurance: SOP for Cleaning and Sanitation

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SOP for Cleaning and Sanitation Standard Operating Procedure for Cleaning and Sanitation 1) Purpose This SOP outlines the procedures for cleaning and sanitation of pharmaceutical manufacturing facilities and equipment to maintain cleanliness, prevent cross-contamination, and ensure compliance with regulatory requirements. 2) Scope This SOP applies to all areas, equipment, and surfaces within the pharmaceutical manufacturing…

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Quality Assurance

Quality Assurance: SOP for Contamination Control

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SOP for Contamination Control Standard Operating Procedure for Contamination Control 1) Purpose This SOP outlines the procedures for controlling contamination risks in pharmaceutical manufacturing processes to ensure product quality and compliance with regulatory standards. 2) Scope This SOP applies to all areas and processes within the pharmaceutical manufacturing facility where contamination control measures are critical….

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Quality Assurance

SOP for Cleanroom Behavior and Monitoring

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SOP for Cleanroom Behavior and Monitoring Standard Operating Procedure for Cleanroom Behavior and Monitoring 1) Purpose This SOP outlines the procedures for maintaining appropriate behavior and monitoring conditions within cleanrooms to ensure cleanliness and minimize contamination risks. 2) Scope This SOP applies to all personnel entering and working in cleanrooms within the pharmaceutical manufacturing facility….

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Quality Assurance

SOP for Aseptic Technique Training

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SOP for Aseptic Technique Training Standard Operating Procedure for Aseptic Technique Training 1) Purpose This SOP outlines the procedures for training personnel in aseptic techniques to maintain sterility and minimize contamination risks during pharmaceutical manufacturing. 2) Scope This SOP applies to all personnel involved in aseptic operations within the pharmaceutical manufacturing facility. 3) Responsibilities The…

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Quality Assurance

SOP for Gowning Procedure

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SOP for Gowning Procedure Standard Operating Procedure for Gowning Procedure 1) Purpose This SOP outlines the gowning procedures to be followed by personnel entering controlled environments, such as cleanrooms, to prevent contamination of pharmaceutical products. 2) Scope This SOP applies to all personnel who are required to gown and enter controlled environments within the pharmaceutical…

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Quality Assurance

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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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