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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Author: Auditor

Capsule: SOP for Labeling Bottled Capsules – V 2.0

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Capsule: SOP for Labeling Bottled Capsules – V 2.0 Standard Operating Procedure for Labeling Bottled Capsules Department Capsule Packaging SOP No. SOP/CP/203/2025 Supersedes SOP/CP/203/2022 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 outlines the procedure for labeling bottled capsules to ensure that all capsules…

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Capsules V 2.0

BA-BE Studies: SOP for Audio-Visual Consent Recording in India – V 2.0

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BA-BE Studies: SOP for Audio-Visual Consent Recording in India – V 2.0 Standard Operating Procedure for Audio-Visual Consent Recording in India for BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/024/2025 Supersedes SOP/BA-BE/024/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for conducting,…

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BA-BE Studies V 2.0

Tablets: SOP for Review and Approval of Process Deviations – V 2.0

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Tablets: SOP for Review and Approval of Process Deviations – V 2.0 Standard Operating Procedure for Review and Approval of Process Deviations Department Tablet SOP No. SOP/TAB/212/2025 Supersedes SOP/TAB/212/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose This SOP outlines the procedure for reviewing and approving…

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Tablet Manufacturing V2.0

Aerosol: SOP for Conducting Accelerated Stability Studies for Aerosol Products – V 2.0

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Aerosol: SOP for Conducting Accelerated Stability Studies for Aerosol Products – V 2.0 SOP for Conducting Accelerated Stability Studies for Aerosol Products Department Aerosol SOP No. SOP/Aerosol/101/2025 Supersedes SOP/Aerosol/101/2022 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 procedure for…

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Aerosols V 2.0

Capsule: SOP for Bottling Capsules in High-Speed Packaging Lines – V 2.0

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Capsule: SOP for Bottling Capsules in High-Speed Packaging Lines – V 2.0 Standard Operating Procedure for Bottling Capsules in High-Speed Packaging Lines Department Capsule Packaging SOP No. SOP/CP/202/2025 Supersedes SOP/CP/202/2022 Page No. Page 1 of 6 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to outline…

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Capsules V 2.0

BA-BE Studies: SOP for Translation and Back-Translation of Consent Forms – V 2.0

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BA-BE Studies: SOP for Translation and Back-Translation of Consent Forms – V 2.0 Standard Operating Procedure for Translation and Back-Translation of Consent Forms in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/023/2025 Supersedes SOP/BA-BE/023/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a standard…

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BA-BE Studies V 2.0

Creams: SOP for Operating Ointment Mills in Cream Manufacturing – V 2.0

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Creams: SOP for Operating Ointment Mills in Cream Manufacturing – V 2.0 Standard Operating Procedure for Operating Ointment Mills in Cream Manufacturing Department Creams SOP No. SOP/CRM/085/2025 Supersedes SOP/CRM/085/2022 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 procedure for operating ointment mills…

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Creams V 2.0

Capsule: SOP for Blister Packaging of Capsules – V 2.0

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Capsule: SOP for Blister Packaging of Capsules – V 2.0 Standard Operating Procedure for Blister Packaging of Capsules Department Capsule Packaging SOP No. SOP/CP/201/2025 Supersedes SOP/CP/201/2022 Page No. Page 1 of 6 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to outline the procedure for blister…

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Capsules V 2.0

Tablets: SOP for Investigating Tablet Coating Defects – V 2.0

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Tablets: SOP for Investigating Tablet Coating Defects – V 2.0 Standard Operating Procedure for Investigating Tablet Coating Defects Department Tablet SOP No. SOP/TAB/211/2025 Supersedes SOP/TAB/211/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose This SOP defines the process for investigating coating defects in tablet production. The…

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Tablet Manufacturing V2.0

BA-BE Studies: SOP for Developing Informed Consent Documents – V 2.0

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BA-BE Studies: SOP for Developing Informed Consent Documents – V 2.0 Standard Operating Procedure for Developing Informed Consent Documents in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/022/2025 Supersedes SOP/BA-BE/022/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the process for developing, reviewing, and…

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BA-BE Studies 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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