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Author: Auditor

Capsule: SOP for Mixing and Blending of APIs and Excipients – V 2.0

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Capsule: SOP for Mixing and Blending of APIs and Excipients – V 2.0 Standard Operating Procedure for Mixing and Blending of APIs and Excipients Department Capsule Manufacturing SOP No. SOP/CM/052/2025 Supersedes SOP/CM/052/2022 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…

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Capsules V 2.0

Ointments: SOP for Performance Qualification (PQ) of Filling Machines – V 2.0

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SOP for Performance Qualification (PQ) of Filling Machines – V 2.0 Procedure for Performance Qualification (PQ) of Filling Machines Department Quality Assurance (QA)/Validation/Engineering/Production SOP No. SOP/Ointment/134 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…

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Ointments V 2.0

Aerosol: SOP for Documenting Machine Operations – V 2.0

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Aerosol: SOP for Documenting Machine Operations – V 2.0 SOP for Documenting Machine Operations Department Aerosol SOP No. SOP/Aerosol/050/2025 Supersedes SOP/Aerosol/050/2022 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 documenting machine operations during aerosol manufacturing. The purpose…

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Aerosols V 2.0

SOP for Handling and Storage of Volatile Raw Materials – V 2.0

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SOP for Handling and Storage of Volatile Raw Materials – V 2.0 Standard Operating Procedure for Handling and Storage of Volatile Raw Materials Department Warehouse / Quality Assurance SOP No. SOP/RM/112/2025 Supersedes SOP/RM/112/2022 Page No. Page 1 of 15 Issue Date 12/02/2025 Effective Date 16/02/2025 Review Date 12/02/2026 1. Purpose This Standard Operating Procedure (SOP)…

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Raw Material Warehouse V 2.0

Creams: SOP for Feasibility Studies in Cream Development – V 2.0

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Creams: SOP for Feasibility Studies in Cream Development – V 2.0 Standard Operating Procedure for Feasibility Studies in Cream Development Department Creams SOP No. SOP/CRM/022/2025 Supersedes SOP/CRM/022/2022 Page No. Page 1 of 5 Issue Date 15/06/2025 Effective Date 20/06/2025 Review Date 15/06/2026 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to provide…

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Creams V 2.0

Tablets: SOP for In-Process Friability Testing for Tablets – V 2.0

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Tablets: SOP for In-Process Friability Testing for Tablets – V 2.0 Standard Operating Procedure for In-Process Friability Testing for Tablets Department Quality Control SOP No. SOP/TAB/133/2025 Supersedes SOP/TAB/133/2022 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 conducting in-process friability testing on…

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Tablet Manufacturing V2.0

Capsule: SOP for Preparing Gelatin Solution for Capsule Shells – V 2.0

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Capsule: SOP for Preparing Gelatin Solution for Capsule Shells – V 2.0 Standard Operating Procedure for Preparing Gelatin Solution for Capsule Shells Department Capsule Manufacturing SOP No. SOP/CM/051/2025 Supersedes SOP/CM/051/2022 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

Capsule: SOP for Formulating Nutraceutical Capsules – V 2.0

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Capsule: SOP for Formulating Nutraceutical Capsules – V 2.0 Standard Operating Procedure for Formulating Nutraceutical Capsules Department Capsule Manufacturing SOP No. SOP/CM/050/2025 Supersedes SOP/CM/050/2022 Page No. Page 1 of 7 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to define the procedures for formulating nutraceutical capsules….

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Capsules V 2.0

Ointments: SOP for Operational Qualification (OQ) of Mixing Tanks – V 2.0

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SOP for Operational Qualification (OQ) of Mixing Tanks – V 2.0 Procedure for Operational Qualification (OQ) of Mixing Tanks Department Quality Assurance (QA)/Validation/Engineering/Production SOP No. SOP/Ointment/133 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…

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Ointments V 2.0

Tablets: SOP for Adhesion Monitoring in Sugar-Coated Tablets – V 2.0

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Tablets: SOP for Adhesion Monitoring in Sugar-Coated Tablets – V 2.0 Standard Operating Procedure for Adhesion Monitoring in Sugar-Coated Tablets Department Quality Control SOP No. SOP/TAB/132/2025 Supersedes SOP/TAB/132/2022 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 monitoring the adhesion of sugar…

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Tablet Manufacturing V2.0

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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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