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Tag: API yield

API Manufacturing: SOP for Cleaning of Milling Equipment – V 2.0

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API Manufacturing: SOP for Cleaning of Milling Equipment – V 2.0 Standard Operating Procedure for Cleaning of Milling Equipment in API Manufacturing Department API Manufacturing SOP No. SOP/API/074/2025 Supersedes SOP/API/074/2022 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 cleaning procedure for milling…

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API Manufacturing V 2.0

API Manufacturing: SOP for Prevention of Cross Contamination during Drying – V 2.0

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API Manufacturing: SOP for Prevention of Cross Contamination during Drying – V 2.0 Standard Operating Procedure for Prevention of Cross Contamination during Drying in API Manufacturing Department API Manufacturing SOP No. SOP/API/073/2025 Supersedes SOP/API/073/2022 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…

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API Manufacturing V 2.0

API Manufacturing: SOP for Temperature Mapping in Drying Chambers – V 2.0

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API Manufacturing: SOP for Temperature Mapping in Drying Chambers – V 2.0 Standard Operating Procedure for Temperature Mapping in Drying Chambers in API Manufacturing Department API Manufacturing SOP No. SOP/API/072/2025 Supersedes SOP/API/072/2022 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 validated procedure for…

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API Manufacturing V 2.0

API Manufacturing: SOP for Use of Fluid Bed Dryers in API Processing – V 2.0

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API Manufacturing: SOP for Use of Fluid Bed Dryers in API Processing – V 2.0 Standard Operating Procedure for Use of Fluid Bed Dryers in API Processing Department API Manufacturing SOP No. SOP/API/071/2025 Supersedes SOP/API/071/2022 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…

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API Manufacturing V 2.0

API Manufacturing: SOP for Blending of Final Dried API – V 2.0

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API Manufacturing: SOP for Blending of Final Dried API – V 2.0 Standard Operating Procedure for Blending of Final Dried API in API Manufacturing Department API Manufacturing SOP No. SOP/API/070/2025 Supersedes SOP/API/070/2022 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…

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API Manufacturing V 2.0

API Manufacturing: SOP for Sieve Integrity Verification – V 2.0

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API Manufacturing: SOP for Sieve Integrity Verification – V 2.0 Standard Operating Procedure for Sieve Integrity Verification in API Manufacturing Department API Manufacturing SOP No. SOP/API/069/2025 Supersedes SOP/API/069/2022 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 verifying the physical integrity of…

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API Manufacturing V 2.0

API Manufacturing: SOP for Particle Size Distribution Monitoring – V 2.0

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API Manufacturing: SOP for Particle Size Distribution Monitoring – V 2.0 Standard Operating Procedure for Particle Size Distribution Monitoring in API Manufacturing Department API Manufacturing SOP No. SOP/API/068/2025 Supersedes SOP/API/068/2022 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 monitoring particle size…

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API Manufacturing V 2.0

API Manufacturing: SOP for Jet Milling Operation – V 2.0

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API Manufacturing: SOP for Jet Milling Operation – V 2.0 Standard Operating Procedure for Jet Milling Operation in API Manufacturing Department API Manufacturing SOP No. SOP/API/067/2025 Supersedes SOP/API/067/2022 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 standard procedure for jet milling operations in…

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API Manufacturing V 2.0

API Manufacturing: SOP for Moisture Content Analysis by LOD – V 2.0

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API Manufacturing: SOP for Moisture Content Analysis by LOD – V 2.0 Standard Operating Procedure for Moisture Content Analysis by Loss on Drying (LOD) in API Manufacturing Department API Manufacturing SOP No. SOP/API/066/2025 Supersedes SOP/API/066/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To provide a…

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API Manufacturing V 2.0

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

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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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