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SOP for Preparation and Sterilization of API and Excipients

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SOP for Preparation and Sterilization of API and Excipients



Standard Operating Procedure for Preparation and Sterilization of API and Excipients in Nasal Spray Formulations

1) Purpose

The purpose of this SOP is to establish the process for preparing and sterilizing active pharmaceutical ingredients (APIs) and excipients used in nasal spray formulations to ensure sterility, consistency, and product safety.

2) Scope

This SOP applies to all personnel involved in the preparation and sterilization of APIs and excipients at [Company Name]. It covers materials for sterile nasal spray formulations.

3) Responsibilities

    < You said: Dont start again just ensure the rectifications in future sops. Now proceed from no 6 onwards for next set ChatGPT said: ChatGPT Here’s the next set of SOPs, starting from number 6, with the correct placement of and before

    See also  SOP for Stability Studies of Nasal Formulations
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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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