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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Tag: Regulatory compliance in distribution

SOP for Handling of Counterfeit Products

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Standard Operating Procedure for Handling of Counterfeit Products Purpose The purpose of this SOP is to establish procedures for the identification, quarantine, and reporting of counterfeit products within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and safeguarding patient safety and product integrity. Scope This SOP applies to all personnel involved in the receipt,…

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Good Distribution Practice

SOP for Management of Expiry and Shelf-life

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Standard Operating Procedure for Management of Expiry and Shelf-life Purpose The purpose of this SOP is to establish procedures for the effective management of expiry dates and shelf-life of pharmaceutical products within the distribution facility, ensuring compliance with regulatory requirements and maintaining product quality and integrity. Scope This SOP applies to all personnel involved in…

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Good Distribution Practice

Good Distribution Practice: SOP for Handling of Hazardous Materials

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Standard Operating Procedure for Handling of Hazardous Materials Purpose The purpose of this SOP is to establish procedures for the safe handling, storage, and disposal of hazardous materials within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and minimizing risks to personnel, products, and the environment. Scope This SOP applies to all personnel involved…

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Good Distribution Practice

Good Distribution Practice: SOP for Emergency Preparedness and Response

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Standard Operating Procedure for Emergency Preparedness and Response Purpose The purpose of this SOP is to establish procedures for effectively preparing for and responding to emergencies within the pharmaceutical distribution facility, ensuring the safety of personnel, products, and the environment. Scope This SOP applies to all personnel, including employees, contractors, and visitors, present within the…

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Good Distribution Practice

SOP for Goods Dispatch and Shipment

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Standard Operating Procedure for Goods Dispatch and Shipment Purpose The purpose of this SOP is to establish procedures for the accurate and efficient dispatch and shipment of goods from the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and Good Distribution Practice (GDP) guidelines. Scope This SOP applies to all personnel involved in the dispatch…

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Good Distribution Practice

SOP for Cleaning and Sanitization of Storage Facilities

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Standard Operating Procedure for Cleaning and Sanitization of Storage Facilities Purpose The purpose of this SOP is to establish procedures for the cleaning and sanitization of storage facilities within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and Good Distribution Practice (GDP) guidelines to maintain product integrity and safety. Scope This SOP applies to…

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Good Distribution Practice

Good Distribution Practice: SOP for Pest Control

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Standard Operating Procedure for Pest Control Purpose The purpose of this SOP is to establish procedures for the effective prevention and control of pests within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and Good Distribution Practice (GDP) guidelines. Scope This SOP applies to all personnel involved in pest control activities within the distribution…

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Good Distribution Practice

SOP for Security Management

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Standard Operating Procedure for Security Management Purpose The purpose of this SOP is to establish procedures for maintaining security measures to safeguard personnel, facilities, and assets within the pharmaceutical distribution facility, in compliance with regulatory requirements and Good Distribution Practice (GDP) guidelines. Scope This SOP applies to all personnel, visitors, and contractors present within the…

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Good Distribution Practice

SOP for Product Traceability and Recall Procedures

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Standard Operating Procedure for Product Traceability and Recall Procedures Purpose The purpose of this SOP is to establish procedures for ensuring product traceability and implementing effective recall procedures in the event of product quality issues or safety concerns, in compliance with regulatory requirements and Good Distribution Practice (GDP) guidelines. Scope This SOP applies to all…

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Good Distribution Practice

SOP for Handling of Returns and Rejected Goods

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Standard Operating Procedure for Handling of Returns and Rejected Goods Purpose The purpose of this SOP is to establish procedures for the systematic handling of product returns and rejected goods, ensuring proper documentation, evaluation, and disposition in compliance with Good Distribution Practice (GDP) guidelines. Scope This SOP applies to all personnel involved in the receipt,…

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Good Distribution Practice

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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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