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Tag: API line clearance

API Manufacturing: SOP for Vacuum Drying Procedure – V 2.0

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API Manufacturing: SOP for Vacuum Drying Procedure – V 2.0 Standard Operating Procedure for Vacuum Drying Procedure in API Manufacturing Department API Manufacturing SOP No. SOP/API/065/2025 Supersedes SOP/API/065/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a standard and validated procedure for drying active…

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API Manufacturing V 2.0

API Manufacturing: SOP for Tray Loading for Drying – V 2.0

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API Manufacturing: SOP for Tray Loading for Drying – V 2.0 Standard Operating Procedure for Tray Loading for Drying in API Manufacturing Department API Manufacturing SOP No. SOP/API/064/2025 Supersedes SOP/API/064/2022 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 procedure for tray loading of…

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API Manufacturing V 2.0

API Manufacturing: SOP for Polymorph Screening Method – V 2.0

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API Manufacturing: SOP for Polymorph Screening Method – V 2.0 Standard Operating Procedure for Polymorph Screening Method in API Manufacturing Department API Manufacturing SOP No. SOP/API/063/2025 Supersedes SOP/API/063/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a standard and scientifically robust procedure for polymorph…

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API Manufacturing V 2.0

API Manufacturing: SOP for Seeding Techniques in Crystallization – V 2.0

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API Manufacturing: SOP for Seeding Techniques in Crystallization – V 2.0 Standard Operating Procedure for Seeding Techniques in Crystallization in API Manufacturing Department API Manufacturing SOP No. SOP/API/062/2025 Supersedes SOP/API/062/2022 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 a standardized procedure for implementing seeding…

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API Manufacturing V 2.0

API Manufacturing: SOP for Crystallization Process Control – V 2.0

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API Manufacturing: SOP for Crystallization Process Control – V 2.0 Standard Operating Procedure for Crystallization Process Control in API Manufacturing Department API Manufacturing SOP No. SOP/API/061/2025 Supersedes SOP/API/061/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a standard and validated procedure for carrying out…

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API Manufacturing V 2.0

API Manufacturing: SOP for Use of Cooling Towers and Condensers in Recovery – V 2.0

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API Manufacturing: SOP for Use of Cooling Towers and Condensers in Recovery – V 2.0 Standard Operating Procedure for Use of Cooling Towers and Condensers in Recovery Process in API Manufacturing Department API Manufacturing SOP No. SOP/API/060/2025 Supersedes SOP/API/060/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1….

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API Manufacturing V 2.0

API Manufacturing: SOP for Emergency Handling in Solvent Area – V 2.0

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API Manufacturing: SOP for Emergency Handling in Solvent Area – V 2.0 Standard Operating Procedure for Emergency Handling in Solvent Area in API Manufacturing Department API Manufacturing SOP No. SOP/API/059/2025 Supersedes SOP/API/059/2022 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 emergency handling procedures…

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API Manufacturing V 2.0

API Manufacturing: SOP for Equipment Cleaning and Validation in Solvent Units – V 2.0

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API Manufacturing: SOP for Equipment Cleaning and Validation in Solvent Units – V 2.0 Standard Operating Procedure for Equipment Cleaning and Validation in Solvent Units in API Manufacturing Department API Manufacturing SOP No. SOP/API/058/2025 Supersedes SOP/API/058/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish…

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API Manufacturing V 2.0

API Manufacturing: SOP for Monitoring of Recovered Solvent Odor and Clarity – V 2.0

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API Manufacturing: SOP for Monitoring of Recovered Solvent Odor and Clarity – V 2.0 Standard Operating Procedure for Monitoring of Recovered Solvent Odor and Clarity in API Manufacturing Department API Manufacturing SOP No. SOP/API/057/2025 Supersedes SOP/API/057/2022 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…

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API Manufacturing V 2.0

API Manufacturing: SOP for Solvent Transfer Using Pumps – V 2.0

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API Manufacturing: SOP for Solvent Transfer Using Pumps – V 2.0 Standard Operating Procedure for Solvent Transfer Using Pumps in API Manufacturing Department API Manufacturing SOP No. SOP/API/056/2025 Supersedes SOP/API/056/2022 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 procedure for the safe and…

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API Manufacturing 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
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers 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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