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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Author: Auditor

SOP for Storage Conditions for Finished Products

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SOP for Storage Conditions for Finished Products Standard Operating Procedure for Storage Conditions for Finished Products 1) Purpose The purpose of this SOP is to define the procedures for the storage of finished pharmaceutical products to maintain their integrity, stability, and quality throughout the storage period. 2) Scope This SOP applies to all personnel involved…

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Injectables

Maintenance Dept.: Maintenance Dept.: SOP for Budgeting and Cost Control in Maintenance

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SOP for Budgeting and Cost Control in Maintenance Standard Operating Procedure for Budgeting and Cost Control in Maintenance 1) Purpose The purpose of this SOP is to establish guidelines for budgeting and cost control in maintenance activities to ensure efficient allocation of resources and adherence to financial plans in pharmaceutical manufacturing facilities. 2) Scope This…

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Maintenance Dept.

SOP for Serialization and Traceability

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SOP for Serialization and Traceability Standard Operating Procedure for Serialization and Traceability 1) Purpose This SOP outlines the procedures for implementing serialization and traceability systems for pharmaceutical products to comply with regulatory requirements, prevent counterfeit products, and enhance supply chain visibility. 2) Scope This SOP applies to all pharmaceutical products subject to serialization requirements, including…

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Quality Assurance

Maintenance Dept.: SOP for Contractor Management in Maintenance

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SOP for Contractor Management in Maintenance Standard Operating Procedure for Contractor Management in Maintenance 1) Purpose The purpose of this SOP is to establish guidelines for the management of contractors involved in maintenance activities to ensure safety, compliance, and efficiency in pharmaceutical manufacturing facilities. 2) Scope This SOP applies to all contractors and subcontractors performing…

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Maintenance Dept.

SOP for Artwork and Label Approval

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SOP for Artwork and Label Approval Standard Operating Procedure for Artwork and Label Approval 1) Purpose This SOP outlines the procedures for the approval of artwork and labeling used in the manufacture and packaging of pharmaceutical products to ensure compliance with regulatory requirements and product specifications. 2) Scope This SOP applies to all artwork and…

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Quality Assurance

SOP for Visual Inspection of Finished Products

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SOP for Visual Inspection of Finished Products Standard Operating Procedure for Visual Inspection of Finished Products 1) Purpose The purpose of this SOP is to establish procedures for the visual inspection of finished pharmaceutical products to ensure they meet quality standards before release for distribution. 2) Scope This SOP applies to all personnel involved in…

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Injectables

Maintenance Dept.: Maintenance Dept.: Maintenance Dept.: SOP for Continuous Improvement in Maintenance Activities

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SOP for Continuous Improvement in Maintenance Activities Standard Operating Procedure for Continuous Improvement in Maintenance Activities 1) Purpose The purpose of this SOP is to establish guidelines for continuous improvement initiatives in maintenance activities to enhance efficiency, reliability, and compliance in pharmaceutical manufacturing facilities. 2) Scope This SOP applies to all maintenance activities conducted within…

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Maintenance Dept.

SOP for Quality Control of Packaging and Labeling

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SOP for Quality Control of Packaging and Labeling Standard Operating Procedure for Quality Control of Packaging and Labeling 1) Purpose This SOP outlines the procedures for ensuring the quality control of packaging materials and labeling used in the manufacture of pharmaceutical products to ensure compliance with regulatory requirements and product specifications. 2) Scope This SOP…

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Quality Assurance

SOP for Maintenance Documentation and Record Keeping

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SOP for Maintenance Documentation and Record Keeping Standard Operating Procedure for Maintenance Documentation and Record Keeping 1) Purpose The purpose of this SOP is to establish guidelines for the documentation and record keeping of maintenance activities to ensure compliance with regulatory requirements and facilitate effective maintenance management in pharmaceutical manufacturing facilities. 2) Scope This SOP…

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Maintenance Dept.

SOP for Trending and Data Analysis

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SOP for Trending and Data Analysis Standard Operating Procedure for Trending and Data Analysis 1) Purpose This SOP outlines the procedures for trending and analyzing data related to quality metrics, deviations, complaints, and other relevant parameters to identify trends, patterns, and potential areas for improvement within the organization. 2) Scope This SOP applies to all…

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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
  • 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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