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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOPs for Purchase Departments

SOP for Supplier Corrective Action

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SOP for Supplier Corrective Action Supplier Corrective Action – Standard Operating Procedure 1) Purpose To establish a standardized process for addressing and correcting non-conformances and deficiencies identified with suppliers, ensuring continuous improvement and adherence to quality standards within the pharmaceutical purchase department. 2) Scope This SOP applies to all supplier-related non-conformances, including quality issues, delivery…

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Purchase Departments

SOP for Inventory Management

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SOP for Inventory Management Inventory Management – Standard Operating Procedure 1) Purpose To establish a standardized process for managing inventory levels effectively, ensuring adequate stock availability while minimizing excess inventory within the pharmaceutical purchase department. 2) Scope This SOP applies to all inventory management activities, including stock monitoring, replenishment, storage, and inventory record-keeping. 3) Responsibilities…

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Purchase Departments

SOP for Purchase Return Process

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SOP for Purchase Return Process Purchase Return Process – Standard Operating Procedure 1) Purpose To establish a standardized procedure for managing the return of purchased goods that are defective, damaged, or otherwise unacceptable, ensuring compliance with contractual agreements and regulatory requirements within the pharmaceutical purchase department. 2) Scope This SOP applies to all returns of…

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Purchase Departments

SOP for Handling of Expired Materials

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SOP for Handling of Expired Materials Handling Expired Materials – Standard Operating Procedure 1) Purpose To establish a standardized process for handling expired materials to ensure compliance with regulatory requirements and prevent the use of expired materials in production within the pharmaceutical purchase department. 2) Scope This SOP applies to all materials, including raw materials,…

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Purchase Departments

SOP for Handling of Import and Export Documentation

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SOP for Handling of Import and Export Documentation Handling of Import and Export Documentation – Standard Operating Procedure 1) Purpose To establish a standardized process for handling import and export documentation to ensure compliance with regulatory requirements, facilitate smooth customs clearance, and maintain accurate records within the pharmaceutical purchase department. 2) Scope This SOP applies…

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Purchase Departments

SOP for Multi-sourcing and Supplier Diversification

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SOP for Multi-sourcing and Supplier Diversification Multi-sourcing and Supplier Diversification – Standard Operating Procedure 1) Purpose To establish a standardized process for implementing multi-sourcing and supplier diversification strategies to mitigate risks, ensure supply continuity, and enhance competitiveness within the pharmaceutical purchase department. 2) Scope This SOP applies to all sourcing activities and supplier management practices…

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Purchase Departments

SOP for Supplier Performance Feedback

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SOP for Supplier Performance Feedback Supplier Performance Feedback – Standard Operating Procedure 1) Purpose To establish a standardized process for providing feedback to suppliers on their performance, with the aim of fostering continuous improvement and maintaining high standards in the procurement process within the pharmaceutical purchase department. 2) Scope This SOP applies to all suppliers…

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Purchase Departments

SOP for Handling and Storage of Procured Goods

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SOP for Handling and Storage of Procured Goods Handling and Storage of Procured Goods – Standard Operating Procedure 1) Purpose To establish a standardized process for the proper handling and storage of procured goods to ensure their quality, safety, and compliance with regulatory requirements within the pharmaceutical purchase department. 2) Scope This SOP applies to…

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Purchase Departments

SOP for Procurement Process Improvement

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SOP for Procurement Process Improvement Procurement Process Improvement – Standard Operating Procedure 1) Purpose To establish a standardized process for continuous improvement of procurement activities to enhance efficiency, reduce costs, and ensure compliance within the pharmaceutical purchase department. 2) Scope This SOP applies to all procurement processes and activities within the pharmaceutical purchase department. 3)…

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Purchase Departments

SOP for IT Systems Used in Procurement

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SOP for IT Systems Used in Procurement IT Systems Used in Procurement – Standard Operating Procedure 1) Purpose To establish a standardized process for the utilization, management, and maintenance of IT systems used in the procurement process to ensure efficiency, data accuracy, and compliance within the pharmaceutical purchase department. 2) Scope This SOP applies to…

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Purchase Departments

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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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