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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOPs for Good Warehousing Practices

Good Warehousing Practices (GWP) are of paramount importance in the pharmaceutical industry to ensure the integrity, safety, and efficacy of pharmaceutical products throughout the supply chain. Adhering to GWP standards helps in maintaining product quality by providing suitable storage conditions, such as temperature and humidity control, to prevent degradation and contamination. Additionally, GWP ensures accurate inventory management, facilitating efficient stock rotation and adherence to FIFO principles, which minimize the risk of expired or obsolete products. Proper handling, labeling, and documentation procedures prescribed by GWP guidelines enhance traceability and accountability, enabling quick and accurate product recalls if necessary. By implementing GWP, pharmaceutical companies can safeguard patient health, comply with regulatory requirements, and uphold their reputation for delivering high-quality and reliable medications.

SOP for Emergency Lighting

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Standard Operating Procedure for Emergency Lighting Purpose The purpose of this SOP is to establish procedures for testing and maintaining emergency lighting systems in the warehouse to ensure adequate illumination during power outages or emergencies in the pharmaceutical facility. Scope This SOP applies to all personnel responsible for testing, inspecting, and maintaining emergency lighting systems…

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Good Warehousing Practices

SOP for Cross-Docking

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Standard Operating Procedure for Cross-Docking Purpose The purpose of this SOP is to establish guidelines for implementing cross-docking practices in the warehouse to streamline operations, reduce handling costs, and improve efficiency in the pharmaceutical facility. Scope This SOP applies to all personnel involved in cross-docking activities, including receiving, sorting, staging, and shipping goods. Responsibilities Warehouse…

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Good Warehousing Practices

SOP for Hygiene Practices

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Standard Operating Procedure for Hygiene Practices Purpose The purpose of this SOP is to establish procedures for maintaining personal hygiene and cleanliness in the warehouse to ensure product safety, prevent contamination, and comply with regulatory requirements in the pharmaceutical facility. Scope This SOP applies to all personnel working in the warehouse, including employees, contractors, and…

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Good Warehousing Practices

SOP for Product Segregation

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Standard Operating Procedure for Product Segregation Purpose The purpose of this SOP is to establish guidelines for segregating different types of products within the warehouse to prevent contamination, ensure product integrity, and maintain regulatory compliance in the pharmaceutical facility. Scope This SOP applies to all personnel involved in receiving, storing, picking, packing, and shipping pharmaceutical…

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Good Warehousing Practices

SOP for Risk Assessment

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Standard Operating Procedure for Risk Assessment Purpose The purpose of this SOP is to establish procedures for assessing and mitigating risks associated with warehouse operations in the pharmaceutical facility to ensure the safety of personnel, protect assets, and prevent operational disruptions. Scope This SOP applies to all personnel involved in planning, executing, and monitoring warehouse…

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Good Warehousing Practices

Good Warehousing Practices: SOP for Equipment Calibration

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Standard Operating Procedure for Equipment Calibration Purpose The purpose of this SOP is to establish guidelines for calibrating equipment used in warehouse operations within the pharmaceutical facility to ensure accuracy, reliability, and compliance with regulatory requirements. Scope This SOP applies to all personnel involved in the calibration, maintenance, and use of equipment critical to warehouse…

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Good Warehousing Practices

Good Warehousing Practices: SOP for Complaint Handling

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Standard Operating Procedure for Complaint Handling Purpose The purpose of this SOP is to establish procedures for handling and resolving customer complaints related to warehouse operations in the pharmaceutical facility to ensure timely resolution, customer satisfaction, and continuous improvement. Scope This SOP applies to all personnel involved in receiving, documenting, investigating, and resolving customer complaints…

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Good Warehousing Practices

Good Warehousing Practices: SOP for Change Control

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 Standard Operating Procedure for Change Control Purpose The purpose of this SOP is to establish guidelines for managing changes to warehouse processes or procedures in the pharmaceutical facility to ensure compliance, minimize risks, and maintain operational efficiency. Scope This SOP applies to all personnel involved in proposing, reviewing, approving, implementing, and documenting changes to warehouse…

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Good Warehousing Practices

SOP for Vendor Audits

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Standard Operating Procedure for Vendor Audits Purpose The purpose of this SOP is to establish procedures for auditing and evaluating vendors and suppliers of pharmaceutical products to ensure compliance with quality standards, regulatory requirements, and contractual agreements. Scope This SOP applies to all personnel involved in vendor management, procurement, quality assurance, and warehouse operations within…

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Good Warehousing Practices

Good Warehousing Practices: SOP for Internal Audits

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Standard Operating Procedure for Internal Audits Purpose The purpose of this SOP is to establish guidelines for conducting internal audits of warehouse operations within the pharmaceutical facility to ensure compliance with regulatory requirements, identify areas for improvement, and maintain operational excellence. Scope This SOP applies to all personnel involved in internal audit activities within the…

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Good Warehousing Practices

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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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