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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOPs for Lyophilized Products

SOP for Use of Humectants in Lyophilized Products

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This SOP outlines the process of incorporating humectants into lyophilized products to ensure moisture retention and stability during storage and reconstitution.
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Lyophilized Products

SOP for Preparation of Lyophilized Formulations for Ophthalmic Use

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This SOP outlines the procedure for preparing lyophilized formulations intended for ophthalmic use, ensuring product sterility, stability, and compatibility with the ocular environment.
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Lyophilized Products

SOP for Incorporation of Taste-Masking Agents in Lyophilized Products

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This SOP outlines the process of incorporating taste-masking agents into lyophilized products, ensuring palatability while maintaining product efficacy and stability.
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Lyophilized Products

SOP for Preparing Lyophilized Formulations for Pulmonary Delivery

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This SOP outlines the procedure for preparing lyophilized formulations intended for pulmonary delivery, ensuring the product is stable, effectively delivered, and compatible with pulmonary devices.
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Lyophilized Products

SOP for Use of Polyols in Lyophilized Formulations

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This SOP outlines the procedure for incorporating polyols (e.g., mannitol, sorbitol) into lyophilized formulations to enhance stability and act as bulking agents, cryoprotectants, or stabilizers.
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Lyophilized Products

SOP for Preparing Lyophilized Formulations for Oral Administration

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This SOP outlines the procedure for preparing lyophilized formulations intended for oral administration, ensuring stability, bioavailability, and ease of ingestion.
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Lyophilized Products

SOP for Development of Lyophilized Formulations for Sublingual Tablets

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This SOP outlines the procedure for the development of lyophilized formulations intended for sublingual tablets, ensuring rapid dissolution, bioavailability, and patient compliance.
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Lyophilized Products

SOP for Incorporation of Controlled Release Agents in Lyophilized Products

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This SOP outlines the procedure for incorporating controlled release agents into lyophilized products, ensuring prolonged release of the active ingredients over a specific duration while maintaining product stability.
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Lyophilized Products

SOP for Preparation of Lyophilized Formulations for Sublingual Delivery

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This SOP outlines the process for preparing lyophilized formulations intended for sublingual delivery, ensuring rapid dissolution, stability, and bioavailability through the sublingual route.
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Lyophilized Products

SOP for Optimization of pH and Ionic Strength in Lyophilized Formulations

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This SOP outlines the procedure for optimizing pH and ionic strength in lyophilized formulations to ensure product stability, efficacy, and proper reconstitution.
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Lyophilized Products

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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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