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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Author: Auditor

Ointments: SOP for Ensuring Validation Compliance – V 2.0

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SOP for Ensuring Validation Compliance – V 2.0 Procedure for Ensuring Validation Compliance Department Quality Assurance (QA)/Validation/Production SOP No. SOP/Ointment/119 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 of this Standard Operating Procedure (SOP) is…

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Ointments V 2.0

Creams: SOP for Preventing Contamination during Material Dispensing – V 2.0

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Creams: SOP for Preventing Contamination during Material Dispensing – V 2.0 Standard Operating Procedure for Preventing Contamination during Material Dispensing Department Creams SOP No. SOP/CRM/010/2025 Supersedes SOP/CRM/010/2022 Page No. Page 1 of 5 Issue Date 15/04/2025 Effective Date 20/04/2025 Review Date 15/04/2026 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to define…

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Creams V 2.0

Tablets: SOP for Granule and Powder Flowability Testing – V 2.0

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Tablets: SOP for Granule and Powder Flowability Testing – V 2.0 Standard Operating Procedure for Granule and Powder Flowability Testing Department Quality Control SOP No. SOP/TAB/118/2025 Supersedes SOP/TAB/118/2022 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 procedure for testing the flowability of granules…

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Tablet Manufacturing V2.0

Capsule: SOP for API and Excipient Compatibility Studies – V 2.0

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Capsule: SOP for API and Excipient Compatibility Studies – V 2.0 Standard Operating Procedure for API and Excipient Compatibility Studies Department Capsule Manufacturing SOP No. SOP/CM/022/2025 Supersedes SOP/CM/022/2022 Page No. Page 1 of 6 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP defines the procedure for conducting compatibility studies between…

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Capsules V 2.0

SOP for Reviewing and Updating Quarantine Procedures Based on Regulatory Changes – V 2.0

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SOP for Reviewing and Updating Quarantine Procedures Based on Regulatory Changes – V 2.0 Standard Operating Procedure for Reviewing and Updating Quarantine Procedures Based on Regulatory Changes Department Quality Assurance / Regulatory Affairs SOP No. SOP/RM/099/2025 Supersedes SOP/RM/099/2022 Page No. Page 1 of 15 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose…

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Raw Material Warehouse V 2.0

Job Safety Analysis for Vacuum Transfer System

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Job Safety Analysis for Vacuum Transfer System JSA for Safe Operation of Vacuum Transfer System JSA Number JSA/OralDosage/039/2025 Department Oral Dosage Revision Number V 1.0 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 05/02/2026 1. Purpose The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Vacuum…

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Oral Dosage Forms (Tablets & Capsules)

Aerosol: SOP for Batch Reconciliation After Manufacturing – V 2.0

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Aerosol: SOP for Batch Reconciliation After Manufacturing – V 2.0 SOP for Batch Reconciliation After Manufacturing Department Aerosol SOP No. SOP/Aerosol/040/2025 Supersedes SOP/Aerosol/040/2022 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) defines the process for performing batch reconciliation after the completion…

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Aerosols V 2.0

Capsule: SOP for Preformulation Studies for Capsule Dosage Forms – V 2.0

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Capsule: SOP for Preformulation Studies for Capsule Dosage Forms – V 2.0 Standard Operating Procedure for Preformulation Studies for Capsule Dosage Forms Department Capsule Manufacturing SOP No. SOP/CM/021/2025 Supersedes SOP/CM/021/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP defines the procedures for conducting preformulation…

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Capsules V 2.0

Ointments: SOP for Validation Protocol Approval – V 2.0

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SOP for Validation Protocol Approval – V 2.0 Procedure for Validation Protocol Approval Department Quality Assurance (QA)/Validation/Production SOP No. SOP/Ointment/118 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 of this Standard Operating Procedure (SOP) is…

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Ointments V 2.0

Creams: SOP for Reconciliation of Dispensed Materials – V 2.0

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Creams: SOP for Reconciliation of Dispensed Materials – V 2.0 Standard Operating Procedure for Reconciliation of Dispensed Materials Department Creams SOP No. SOP/CRM/009/2025 Supersedes SOP/CRM/009/2022 Page No. Page 1 of 5 Issue Date 10/04/2025 Effective Date 15/04/2025 Review Date 10/04/2026 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure…

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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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