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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 Handling and Storing Raw Materials in Open Shelving Systems – V 2.0

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SOP for Handling and Storing Raw Materials in Open Shelving Systems – V 2.0 Standard Operating Procedure for Handling and Storing Raw Materials in Open Shelving Systems Department Warehouse / Quality Assurance SOP No. SOP/RM/164/2025 Supersedes SOP/RM/164/2022 Page No. Page 1 of 14 Issue Date 01/04/2025 Effective Date 08/04/2025 Review Date 01/04/2026 1. Purpose This…

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Raw Material Warehouse V 2.0

Ointments: SOP for Adding Viscosity Modifiers in the Mixing Process – V 2.0

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SOP for Adding Viscosity Modifiers in the Mixing Process – V 2.0 Procedure for Adding Viscosity Modifiers in the Mixing Process Department Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Research and Development (R&D) SOP No. SOP/Ointment/193 Supersedes V 1.0 Page No. Page X of Y Issue Date [Insert Issue Date] Effective Date [Insert Effective Date] Review Date [Insert…

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Ointments V 2.0

Aerosol: SOP for Inspecting Aerosol Cans Before Packing – V 2.0

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Aerosol: SOP for Inspecting Aerosol Cans Before Packing – V 2.0 SOP for Inspecting Aerosol Cans Before Packing Department Aerosol SOP No. SOP/Aerosol/091/2025 Supersedes SOP/Aerosol/091/2022 Page No. Page 1 of Y Issue Date 06/02/2025 Effective Date 16/02/2025 Review Date 06/02/2028 1. Purpose This Standard Operating Procedure (SOP) outlines the process for inspecting aerosol cans before…

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Aerosols V 2.0

Tablets: SOP for Monitoring Critical Process Parameters (CPPs) – V 2.0

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Tablets: SOP for Monitoring Critical Process Parameters (CPPs) – V 2.0 Standard Operating Procedure for Monitoring Critical Process Parameters (CPPs) Department Tablet SOP No. SOP/TAB/196/2025 Supersedes SOP/TAB/196/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose To define the process for monitoring Critical Process Parameters (CPPs) during…

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Tablet Manufacturing V2.0

BA-BE Studies: SOP for Planning of BA/BE Studies – V 2.0

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BA-BE Studies: SOP for Planning of BA/BE Studies – V 2.0 Standard Operating Procedure for Planning of BA/BE Studies in Pharmaceutical Development Department BA-BE Studies SOP No. SOP/BA-BE/001/2025 Supersedes SOP/BA-BE/001/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a systematic and standardized approach for…

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BA-BE Studies V 2.0

Capsule: SOP for Validation of Water Systems for Capsule Shell Production – V 2.0

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Capsule: SOP for Validation of Water Systems for Capsule Shell Production – V 2.0 Standard Operating Procedure for Validation of Water Systems for Capsule Shell Production Department Capsule Manufacturing SOP No. SOP/CM/173/2025 Supersedes SOP/CM/173/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this…

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Capsules V 2.0

API Manufacturing: SOP for Vendor Qualification and Approval Process – V 2.0

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API Manufacturing: SOP for Vendor Qualification and Approval Process – V 2.0 Standard Operating Procedure for Vendor Qualification and Approval in API Manufacturing Department API Manufacturing SOP No. SOP/API/001/2025 Supersedes SOP/API/001/2022 Page No. Page 1 of 12 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose The purpose of this Standard Operating Procedure…

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API Manufacturing V 2.0

Capsule: SOP for Validation of Compressed Air Systems in Capsule Production – V 2.0

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Capsule: SOP for Validation of Compressed Air Systems in Capsule Production – V 2.0 Standard Operating Procedure for Validation of Compressed Air Systems in Capsule Production Department Capsule Manufacturing SOP No. SOP/CM/172/2025 Supersedes SOP/CM/172/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this…

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Capsules V 2.0

Ointments: SOP for Preventing Foaming During Manufacturing – V 2.0

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SOP for Preventing Foaming During Manufacturing – V 2.0 Procedure for Preventing Foaming During Manufacturing Department Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Research and Development (R&D) SOP No. SOP/Ointment/192 Supersedes V 1.0 Page No. Page X of Y Issue Date [Insert Issue Date] Effective Date [Insert Effective Date] Review Date [Insert Review Date] 1. Purpose The purpose…

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Ointments V 2.0

Creams: SOP for Blending and Milling in Cream Formulations – V 2.0

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Creams: SOP for Blending and Milling in Cream Formulations – V 2.0 Standard Operating Procedure for Blending and Milling in Cream Formulations Department Creams SOP No. SOP/CRM/072/2025 Supersedes SOP/CRM/072/2022 Page No. Page 1 of 6 Issue Date 21/01/2026 Effective Date 26/01/2026 Review Date 21/01/2027 1. Purpose This SOP outlines the process for blending and milling…

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Creams V 2.0

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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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