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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 Preparation of Lyophilized Peptide Therapeutics

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This SOP outlines the procedure for preparing lyophilized peptide therapeutics, ensuring that the bioactivity and stability of the peptide is maintained during lyophilization and storage.
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Lyophilized Products

SOP for Preparing Lyophilized Formulations for Pediatrics

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This SOP outlines the procedure for preparing lyophilized formulations for pediatric use, ensuring safety, palatability, and ease of administration.
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Lyophilized Products

Lyophilized Products : SOP for Formulation Optimization for Lyophilized Proteins

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This SOP outlines the procedure for optimizing formulations for lyophilized proteins to ensure maximum stability, bioactivity, and ease of reconstitution.
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Lyophilized Products

Lyophilized Products : SOP for Preparation of Lyophilized Allergen Extracts

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This SOP outlines the procedure for preparing lyophilized allergen extracts, ensuring product stability and bioactivity during storage and reconstitution.
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Lyophilized Products

Lyophilized Products : SOP for Incorporation of Solubility Enhancers in Lyophilized Products

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This SOP outlines the procedure for incorporating solubility enhancers into lyophilized products to improve the solubility of poorly soluble drugs upon reconstitution.
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Lyophilized Products

SOP for Preparation of Lyophilized Biologics

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This SOP outlines the process for preparing lyophilized biologics, ensuring product stability, bioactivity, and proper storage conditions.
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Lyophilized Products

SOP for Formulating Lyophilized Cancer Therapeutics

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This SOP outlines the procedure for formulating lyophilized cancer therapeutics, ensuring the stability and efficacy of the active pharmaceutical ingredient (API) during lyophilization and storage.
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Lyophilized Products

SOP for Incorporation of Immunomodulators in Lyophilized Products

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This SOP outlines the procedure for incorporating immunomodulators into lyophilized products to enhance immune response while ensuring product stability and bioactivity during lyophilization.
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Lyophilized Products

SOP for Preparation of Lyophilized DNA and RNA Formulations

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This SOP outlines the procedure for preparing lyophilized DNA and RNA formulations to ensure the stability and preservation of genetic material during storage and transportation.
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Lyophilized Products

SOP for Preparing Lyophilized Formulations for Topical Application

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This SOP outlines the procedure for preparing lyophilized formulations intended for topical application, ensuring the product is stable, easily reconstituted, and compatible with the skin.
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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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