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Author: Auditor

Aerosol: SOP for Temperature and Humidity Monitoring in Stability Chambers – V 2.0

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Aerosol: SOP for Temperature and Humidity Monitoring in Stability Chambers – V 2.0 SOP for Temperature and Humidity Monitoring in Stability Chambers Department Aerosol SOP No. SOP/Aerosol/106/2025 Supersedes SOP/Aerosol/106/2022 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…

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Aerosols V 2.0

Capsule: SOP for Reviewing Batch Manufacturing Records (BMRs) – V 2.0

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Capsule: SOP for Reviewing Batch Manufacturing Records (BMRs) – V 2.0 Standard Operating Procedure for Reviewing Batch Manufacturing Records (BMRs) Department Quality Control SOP No. SOP/QC/217/2025 Supersedes SOP/QC/217/2022 Page No. Page 1 of 5 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 procedure…

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Capsules V 2.0

BA-BE Studies: SOP for Pre-Study Kickoff Meeting Conduct – V 2.0

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BA-BE Studies: SOP for Pre-Study Kickoff Meeting Conduct – V 2.0 Standard Operating Procedure for Pre-Study Kickoff Meeting Conduct in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/034/2025 Supersedes SOP/BA-BE/034/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for conducting a pre-study…

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BA-BE Studies V 2.0

API Manufacturing: SOP for Issuance of Raw Materials to Production – V 2.0

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API Manufacturing: SOP for Issuance of Raw Materials to Production – V 2.0 Standard Operating Procedure for Issuance of Raw Materials to Production in API Manufacturing Department API Manufacturing SOP No. SOP/API/007/2025 Supersedes SOP/API/007/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define the standardized…

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API Manufacturing V 2.0

Tablets: SOP for Handling Non-Conforming Products During Manufacturing – V 2.0

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Tablets: SOP for Handling Non-Conforming Products During Manufacturing – V 2.0 Standard Operating Procedure for Handling Non-Conforming Products During Manufacturing Department Tablet SOP No. SOP/TAB/218/2025 Supersedes SOP/TAB/218/2022 Page No. Page 1 of 5 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose This SOP defines the procedures for identifying, handling, and resolving non-conforming…

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Tablet Manufacturing V2.0

Capsule: SOP for Preparing Batch Manufacturing Records for Capsules – V 2.0

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Capsule: SOP for Preparing Batch Manufacturing Records for Capsules – V 2.0 Standard Operating Procedure for Preparing Batch Manufacturing Records for Capsules Department Production SOP No. SOP/PD/216/2025 Supersedes SOP/PD/216/2022 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 establish a…

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Capsules V 2.0

SOP for Maintaining Correct Storage Order to Prevent Contamination – V 2.0

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SOP for Maintaining Correct Storage Order to Prevent Contamination – V 2.0 Standard Operating Procedure for Maintaining Correct Storage Order to Prevent Contamination Department Warehouse / Quality Assurance SOP No. SOP/RM/176/2025 Supersedes SOP/RM/176/2022 Page No. Page 1 of 15 Issue Date 11/04/2025 Effective Date 18/04/2025 Review Date 11/04/2026 1. Purpose This Standard Operating Procedure (SOP)…

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Raw Material Warehouse V 2.0

Creams: SOP for Maintenance of High-Shear Mixers – V 2.0

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Creams: SOP for Maintenance of High-Shear Mixers – V 2.0 Standard Operating Procedure for Maintenance of High-Shear Mixers Department Creams SOP No. SOP/CRM/091/2025 Supersedes SOP/CRM/091/2022 Page No. Page 1 of 6 Issue Date 21/01/2026 Effective Date 26/01/2026 Review Date 21/01/2027 1. Purpose The purpose of this SOP is to define the procedure for the maintenance…

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Creams V 2.0

API Manufacturing: SOP for Storage of Temperature-Sensitive Materials – V 2.0

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API Manufacturing: SOP for Storage of Temperature-Sensitive Materials – V 2.0 Standard Operating Procedure for Storage of Temperature-Sensitive Materials in API Manufacturing Department API Manufacturing SOP No. SOP/API/006/2025 Supersedes SOP/API/006/2022 Page No. Page 1 of 11 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To describe the procedure for receiving, storing, monitoring,…

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API Manufacturing V 2.0

BA-BE Studies: SOP for Review of SmPC for EU BA/BE Submissions – V 2.0

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BA-BE Studies: SOP for Review of SmPC for EU BA/BE Submissions – V 2.0 Standard Operating Procedure for Review of SmPC for EU BA/BE Submissions Department BA-BE Studies SOP No. SOP/BA-BE/033/2025 Supersedes SOP/BA-BE/033/2022 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 procedure for…

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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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