Standard Operating Procedure for Formulation of Sustained Release Nasal Sprays

1) Purpose

The purpose of this SOP is to provide guidelines for the formulation of sustained-release nasal sprays to ensure prolonged drug release and effective therapeutic action.

2) Scope

This SOP applies to all personnel involved in the formulation and testing of sustained-release nasal sprays at [Company Name].

3) Responsibilities

• Operators: Responsible for preparing the sustained-release formulation according to the specified protocol.
• QA: Verifies the release profile and ensures the formulation meets quality standards.

4) Procedure

4.1 Selection of Release-Controlling Agents

4.1.1 Polymers and Excipients

• Select suitable polymers and excipients (e.g., hydroxypropyl methylcellulose, carbopol) that provide sustained drug release.
• Ensure the excipients meet pharmacopeial standards for sustained-release applications.

4.1.2 Weighing of Ingredients

• Weigh the required amount of polymers and excipients as per the formulation guidelines.
• Document all weights in the batch manufacturing record (BMR).

4.2 Formulation Process

4.2.1 Mixing

• Mix the polymers, excipients, and active pharmaceutical ingredients in the formulation base, ensuring even distribution.

4.2.2 Homogenization

• Use a homogenizer to ensure uniform particle size and dispersion in the sustained-release formulation.

4.3 Release Profile Testing

4.3.1 Dissolution Testing

• Test the sustained-release formulation using a dissolution apparatus to determine the release profile.

4.3.2 Adjustment

• If the release profile does not meet the target, adjust the polymer concentration and repeat the testing.

4.4 Sterilization and Filling

4.4.1 Filtration

• Filter the formulation through a 0.22-micron filter to ensure sterility.

4.4.2 Filling

• Fill the formulation into nasal spray containers under aseptic conditions.

4.5 Documentation

• Document all formulation steps, including ingredient amounts, release profile testing, and final release data in the batch manufacturing record (BMR).

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20. SOP for Formulation of Sustained Release Nasal Sprays (continued)
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5) Abbreviations, if any

• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Dissolution Test Results

7) References, if any

• FDA Guidance for Industry – Dissolution Testing of Immediate and Sustained-Release Dosage Forms

8) SOP Version

Version 1.0

Annexure

Dissolution Test Results Log Template

  

    
Date
    
Formulation
    
Initial Release (%)
    
Sustained Release (over time)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
Release at 1 hour
    
Release over 12/24 hours
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for pH and Osmolality Control in Nasal Formulations

1) Purpose

The purpose of this SOP is to establish guidelines for controlling the pH and osmolality of nasal formulations to ensure product stability, safety, and patient comfort.

2) Scope

This SOP applies to all personnel involved in the formulation, testing, and quality control of nasal sprays and suspensions at [Company Name].

3) Responsibilities

• Operators: Responsible for monitoring and adjusting pH and osmolality during formulation.
• QA: Verifies that pH and osmolality meet formulation specifications and patient safety requirements.

4) Procedure

4.1 pH Control

4.1.1 Equipment Setup

• Ensure the pH meter is calibrated using standard buffer solutions (e.g., pH 4.0 and pH 7.0) before testing the formulation.

4.1.2 pH Adjustment

• Measure the pH of the formulation, and if necessary, adjust the pH by adding a dilute acid (e.g., HCl) or base (e.g., NaOH) to bring it within the target range.

4.2 Osmolality Control

4.2.1 Equipment Setup

• Ensure that the osmolality meter is calibrated and ready for use.

4.2.2 Osmolality Adjustment

• Measure the osmolality of the formulation. If the osmolality is too high, dilute the formulation with purified water or another isotonic solution to bring it within the desired range.

4.3 Documentation

• Document all pH and osmolality readings, adjustments, and final values in the batch manufacturing record (BMR).
• Ensure that QA personnel verify and sign off on all pH and osmolality measurements.

5) Abbreviations, if any

• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• pH and Osmolality Log

7) References, if any

• ICH Q3A – Guidelines on Impurities and Stability Testing

8) SOP Version

Version 1.0

Annexure

pH and Osmolality Log Template

  

    
Date
    
Formulation
    
pH
    
Osmolality (mOsm/kg)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
pH Value
    
Osmolality
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Monitoring Viscosity of Nasal Gels and Suspensions

1) Purpose

The purpose of this SOP is to establish a procedure for monitoring and controlling the viscosity of nasal gels and suspensions to ensure product consistency and proper administration.

2) Scope

This SOP applies to all personnel involved in the preparation, testing, and quality control of nasal gels and suspensions at [Company Name].

3) Responsibilities

• Operators: Responsible for measuring viscosity during the formulation process.
• QA: Verifies viscosity values and ensures they meet product specifications.

4) Procedure

4.1 Viscosity Measurement

4.1.1 Equipment Setup

• Ensure the viscometer is calibrated and properly set up before testing.
• Prepare the appropriate spindle size based on the viscosity range of the formulation.

4.1.2 Sampling

• Take a representative sample of the nasal gel or suspension for viscosity testing.

4.1.3 Testing Procedure

• Set the viscometer at the appropriate speed and temperature for the test as per formulation requirements.
• Record the viscosity values (in cP or mPa·s) and check for consistency with formulation specifications.

4.2 Viscosity Adjustment

4.2.1 Adjustment Methods

• If the viscosity falls outside the target range, adjust the formulation by adding more gel-forming agents or diluents, depending on the need.
• Mix thoroughly to ensure homogeneity after any adjustments.

4.3 Documentation

• Record the viscosity values, any adjustments made, and the final readings in the batch manufacturing record (BMR).
• Document all viscosity measurements in the viscosity log.

5) Abbreviations, if any

• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Viscosity Log

7) References, if any

• USP 39 – Viscosity Testing in Pharmaceutical Preparations

8) SOP Version

Version 1.0

Annexure

Viscosity Log Template

  

    
Date
    
Formulation
    
Viscosity (cP)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
Viscosity
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

17. SOP for Optimizing Particle Size in Nasal Suspensions
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Standard Operating Procedure for Optimizing Particle Size in Nasal Suspensions

1) Purpose

The purpose of this SOP is to outline the procedure for optimizing the particle size in nasal suspensions to ensure uniform drug delivery and effective therapeutic action.

2) Scope

This SOP applies to all personnel involved in the preparation, optimization, and testing of nasal suspensions at [Company Name].

3) Responsibilities

• Operators: Responsible for monitoring and optimizing particle size during formulation.
• QA: Verifies the particle size and ensures that it meets formulation specifications.

4) Procedure

4.1 Selection of Equipment

4.1.1 Homogenizer or Milling Equipment

• Select appropriate equipment (e.g., homogenizer, ball mill) to reduce particle size to the desired range (e.g., 1-10 microns).
• Ensure that the equipment is calibrated and functioning correctly before use.

4.1.2 Particle Size Analyzer

• Ensure the particle size analyzer is calibrated to measure the size distribution accurately.

4.2 Particle Size Reduction

4.2.1 Homogenization

• Add the suspension ingredients into the homogenizer, and adjust the speed and pressure according to formulation guidelines.
• Run the homogenizer for the required time to reduce the particle size.

4.2.2 Milling

• If using a milling process, add the suspension to the ball mill or jet mill and run it at the recommended speed and time.

4.3 Particle Size Analysis

4.3.1 Measurement

• Take a sample of the nasal suspension and measure the particle size distribution using a laser diffraction particle size analyzer or dynamic light scattering (DLS).
• Ensure the particle size falls within the desired range specified in the formulation.

4.4 Stability Testing

4.4.1 Stability of Suspension

• Monitor the suspension stability to ensure the particles remain evenly dispersed and do not aggregate over time.
• Perform stability tests at regular intervals to check particle size, viscosity, and sedimentation.

4.5 Documentation

• Document the particle size reduction process, equipment parameters, and results in the batch manufacturing record (BMR).
• Record the particle size distribution values in the particle size log, including operator initials and QA approval.

5) Abbreviations, if any

• DLS: Dynamic Light Scattering
• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Particle Size Distribution Log

7) References, if any

• USP 39 – Particle Size Analysis of Suspensions

8) SOP Version

Version 1.0

Annexure

Particle Size Distribution Log Template

  

    
Date
    
Formulation
    
Particle Size (µm)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
Size
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Incorporating Anti-Inflammatory Agents in Nasal Sprays

1) Purpose

The purpose of this SOP is to outline the process for incorporating anti-inflammatory agents into nasal spray formulations to ensure consistent dosage and therapeutic efficacy.

2) Scope

This SOP applies to all personnel involved in the formulation of nasal sprays containing anti-inflammatory agents at [Company Name].

3) Responsibilities

• Operators: Responsible for incorporating anti-inflammatory agents into the formulation and ensuring even distribution.
• QA: Verifies the concentration of anti-inflammatory agents and checks for uniformity in the formulation.

4) Procedure

4.1 Selection of Anti-Inflammatory Agents

4.1.1 Types of Anti-Inflammatory Agents

• Select appropriate anti-inflammatory agents based on the therapeutic requirements of the formulation (e.g., corticosteroids, NSAIDs).

4.1.2 Weighing of Agents

• Weigh the required amount of anti-inflammatory agents according to the formulation specifications.
• Document all weights in the batch manufacturing record (BMR).

4.2 Incorporation of Anti-Inflammatory Agents

4.2.1 Mixing

• Mix the anti-inflammatory agent into the nasal spray solution under constant stirring to ensure uniform distribution.

4.2.2 Homogenization

• Use a homogenizer if required to ensure even distribution of the active agent in the formulation.

4.3 Testing

4.3.1 Assay Testing

• Test the formulation to verify that the concentration of the anti-inflammatory agent meets the specified range.

4.3.2 pH and Osmolality Testing

• Test the pH and osmolality of the formulation to ensure it falls within the required range for nasal sprays.

4.4 Filtration and Filling

4.4.1 Filtration

• Filter the formulation through a 0.22-micron filter to ensure sterility.

4.4.2 Filling

• Fill the sterile solution into nasal spray containers using aseptic techniques.

4.5 Documentation

• Document all steps, including the amount of anti-inflammatory agent used, assay results, and pH and osmolality values in the batch manufacturing record (BMR).

5) Abbreviations, if any

• NSAIDs: Non-Steroidal Anti-Inflammatory Drugs
• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• pH and Osmolality Log

7) References, if any

• USP 39 – Anti-Inflammatory Drugs in Nasal Sprays

8) SOP Version

Version 1.0

Annexure

pH and Osmolality Log Template

  

    
Date
    
Formulation
    
pH
    
Osmolality (mOsm/kg)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
pH Value
    
Osmolality
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Use of Permeation Enhancers in Nasal Formulations

1) Purpose

The purpose of this SOP is to outline the process for incorporating permeation enhancers in nasal spray formulations to improve drug absorption and bioavailability.

2) Scope

This SOP applies to all personnel involved in the formulation of nasal sprays with permeation enhancers at [Company Name].

3) Responsibilities

• Operators: Responsible for incorporating permeation enhancers into the formulation and ensuring proper dispersion.
• QA: Verifies the concentration of permeation enhancers and checks for consistency in formulation.

4) Procedure

4.1 Selection of Permeation Enhancers

4.1.1 Types of Permeation Enhancers

• Select appropriate permeation enhancers based on the drug’s physicochemical properties (e.g., bile salts, fatty acids, surfactants).

4.1.2 Weighing of Enhancers

• Weigh the required amount of permeation enhancers according to the formulation specifications.
• Document all weights in the batch manufacturing record (BMR).

4.2 Incorporation of Permeation Enhancers

4.2.1 Mixing

• Mix the permeation enhancer into the formulation under constant stirring to ensure uniform distribution.

4.2.2 Homogenization

• If required, homogenize the formulation to ensure even distribution of the permeation enhancers.

4.3 Testing

4.3.1 pH and Osmolality Testing

• Measure the pH and osmolality of the formulation after the addition of permeation enhancers.

4.4 Sterilization and Filling

4.4.1 Filtration

• Filter the formulation through a 0.22-micron filter to ensure sterility.

4.4.2 Filling

• Fill the sterilized formulation into nasal spray containers using aseptic techniques.

4.5 Documentation

• Document all steps, including the concentration of permeation enhancers used and results of pH and osmolality testing, in the batch manufacturing record (BMR).

5) Abbreviations, if any

• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• pH and Osmolality Log

7) References, if any

• ICH Q6A – Specifications for Drug Substances and Products

8) SOP Version

Version 1.0

Annexure

pH and Osmolality Log Template

  

    
Date
    
Formulation
    
pH
    
Osmolality (mOsm/kg)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
pH Value
    
Osmolality
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preparation of Liposomal Nasal Spray Formulations

1) Purpose

The purpose of this SOP is to outline the process for preparing liposomal nasal spray formulations, ensuring encapsulation efficiency and stability of the liposomes.

2) Scope

This SOP applies to all personnel involved in the formulation, characterization, and testing of liposomal nasal sprays at [Company Name].

3) Responsibilities

• Operators: Responsible for preparing liposomal formulations and ensuring proper encapsulation of the drug.
• QA: Verifies the encapsulation efficiency and ensures the liposomal suspension meets the quality specifications.

4) Procedure

4.1 Liposome Preparation

4.1.1 Lipid Selection

• Select the appropriate lipids (e.g., phospholipids, cholesterol) for the formulation.

4.1.2 Solvent Preparation

• Dissolve the lipids in an organic solvent such as chloroform or ethanol.

4.1.3 Lipid Film Formation

• Evaporate the organic solvent under vacuum using a rotary evaporator to form a thin lipid film.
• Hydrate the lipid film with a drug-containing aqueous phase under constant stirring.

4.2 Liposome Size Reduction

4.2.1 Sonication or Extrusion

• Use sonication or extrusion to reduce the size of liposomes to the desired range (e.g., 100-300 nm).

4.3 Encapsulation Efficiency Testing

4.3.1 Drug Loading

• Determine the encapsulation efficiency by separating free drug from liposome-encapsulated drug using dialysis or ultracentrifugation.

4.4 Sterilization and Filling

4.4.1 Sterilization

• Filter the liposomal suspension through a 0.22-micron filter to ensure sterility.

4.4.2 Filling

• Fill the sterilized suspension into nasal spray containers under aseptic conditions.

4.5 Documentation

• Document all steps, including lipid types, particle size, and encapsulation efficiency in the batch manufacturing record (BMR).

5) Abbreviations, if any

• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Encapsulation Efficiency and Particle Size Log

7) References, if any

• ICH Q8(R2) – Pharmaceutical Development Guidelines

8) SOP Version

Version 1.0

Annexure

Encapsulation Efficiency and Particle Size Log Template

  

    
Date
    
Formulation
    
Encapsulation Efficiency (%)
    
Particle Size (nm)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
Efficiency
    
Size
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

13. SOP for Preparation of Nanoparticles for Intranasal Delivery
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Standard Operating Procedure for Preparation of Nanoparticles for Intranasal Delivery

1) Purpose

The purpose of this SOP is to outline the procedures for preparing nanoparticles for intranasal delivery, ensuring optimal particle size, stability, and bioavailability.

2) Scope

This SOP applies to all personnel involved in the preparation, characterization, and testing of nanoparticles intended for intranasal drug delivery at [Company Name].

3) Responsibilities

• Operators: Responsible for preparing and characterizing nanoparticles according to this SOP.
• QA: Verifies particle size, stability, and ensures that the process adheres to quality standards.

4) Procedure

4.1 Preparation of Nanoparticles

4.1.1 Selection of Materials

• Select appropriate polymers and surfactants (e.g., PLGA, chitosan) for nanoparticle formation.
• Ensure that all materials meet pharmaceutical standards for intranasal drug delivery.

4.1.2 Solvent Preparation

• Prepare a solution of the drug and polymer in an organic solvent (e.g., acetone or ethanol) based on the formulation guidelines.

4.2 Nanoparticle Formation

4.2.1 Emulsification

• Add the drug-polymer solution into an aqueous phase containing surfactants under stirring to form an emulsion.
• Ensure constant stirring to maintain stability of the emulsion.

4.2.2 Solvent Evaporation

• Remove the organic solvent by evaporating under reduced pressure or using a rotary evaporator to solidify the nanoparticles.

4.3 Characterization of Nanoparticles

4.3.1 Particle Size Measurement

• Measure the particle size using dynamic light scattering (DLS) or nanoparticle tracking analysis (NTA) to ensure the particles fall within the target range (e.g., 50-200 nm).

4.3.2 Zeta Potential Testing

• Test the zeta potential of the nanoparticles to evaluate surface charge and stability.

4.4 Sterilization and Storage

4.4.1 Sterilization

• If necessary, sterilize the nanoparticle suspension using a 0.22-micron filter or an appropriate sterilization method.

4.4.2 Storage

• Store the nanoparticle suspension in sterilized containers at controlled temperature conditions to maintain stability.

4.5 Documentation

• Document all steps in the preparation process, including particle size, zeta potential values, and sterilization records in the batch manufacturing record (BMR).

5) Abbreviations, if any

• DLS: Dynamic Light Scattering
• PLGA: Poly(lactic-co-glycolic acid)
• BMR: Batch Manufacturing Record
• QA: Quality Assurance

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Particle Size and Zeta Potential Log

7) References, if any

• FDA Guidance for Industry – Nanomaterials in Drug Products

8) SOP Version

Version 1.0

Annexure

Particle Size and Zeta Potential Log Template

  

    
Date
    
Formulation
    
Particle Size (nm)
    
Zeta Potential (mV)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
Size
    
Potential
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Use of Surfactants in Nasal Formulations

1) Purpose

The purpose of this SOP is to provide guidelines for the appropriate use of surfactants in nasal spray formulations to enhance solubility, stability, and absorption of the active ingredients.

2) Scope

This SOP applies to all personnel involved in the formulation of nasal sprays using surfactants at [Company Name].

3) Responsibilities

• Operators: Responsible for adding surfactants and ensuring they are properly dispersed in the formulation.
• QA: Verifies the surfactant concentration and checks that the formulation meets quality standards.

4) Procedure

4.1 Surfactant Selection

4.1.1 Types of Surfactants

• Select the appropriate surfactant based on the formulation needs, such as Tween 80, polysorbate, or lecithin.
• Ensure that the surfactants used are pharmaceutically acceptable and compatible with the active ingredients and excipients.

4.1.2 Weighing of Surfactants

• Weigh the required amount of surfactants according to the formulation specifications.
• Document all weights in the batch manufacturing record (BMR).

4.2 Incorporation of Surfactants

4.2.1 Dissolution

• Dissolve the surfactant in the nasal spray solution while stirring continuously.
• Ensure that the surfactant is completely dissolved to avoid phase separation or cloudiness in the solution.

4.2.2 Mixing and Homogenization

• Use a homogenizer to ensure uniform distribution of the surfactant in the formulation.

4.3 pH and Osmolality Testing

4.3.1 pH Testing

• Measure the pH of the formulation after adding the surfactant and adjust as necessary.

4.3.2 Osmolality Testing

• Check the osmolality of the solution to ensure it meets the required range for nasal sprays.

4.4 Filtration and Filling

4.4.1 Filtration

• Filter the final solution through a 0.22-micron filter to ensure sterility.

4.4.2 Filling

• Fill the sterile solution into nasal spray containers under aseptic conditions.

4.5 Documentation

• Document all steps, including the type and amount of surfactant used, pH, and osmolality values in the batch manufacturing record (BMR).

5) Abbreviations, if any

• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• pH and Osmolality Log

7) References, if any

• USP 39 – Surfactants in Drug Formulations

8) SOP Version

Version 1.0

Annexure

pH and Osmolality Log Template

  

    
Date
    
Formulation
    
pH
    
Osmolality (mOsm/kg)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
pH Value
    
Osmolality
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Spray Drying for Nasal Powder Formulations

1) Purpose

The purpose of this SOP is to outline the process for using spray drying techniques to prepare nasal powder formulations, ensuring uniform particle size and optimal drug delivery.

2) Scope

This SOP applies to all personnel involved in the spray drying process for nasal powder formulations at [Company Name].

3) Responsibilities

• Operators: Responsible for operating the spray dryer and ensuring correct parameters are followed.
• QA: Verifies that the powder meets the required specifications for particle size and uniformity.

4) Procedure

4.1 Equipment Setup

4.1.1 Spray Dryer Inspection

• Inspect the spray dryer to ensure it is clean and ready for use.
• Check that the nozzles and other components are correctly installed.

4.1.2 Calibration

• Calibrate the spray dryer according to the manufacturer’s specifications.

4.2 Solution Preparation

4.2.1 Dissolving and Mixing

• Dissolve the API and excipients in purified water or another suitable solvent.
• Ensure that the solution is homogenous before feeding it into the spray dryer.

4.3 Spray Drying Process

4.3.1 Process Parameters

• Set the spray dryer to the appropriate parameters, including inlet temperature, outlet temperature, and feed rate.
• Start the spray drying process, ensuring that the feed solution is atomized properly into the drying chamber.

4.3.2 Monitoring

• Monitor the spray drying process continuously to ensure consistent particle size and drying.
• Make adjustments as necessary to the feed rate, air flow, and temperature to optimize the drying process.

4.4 Post-Spray Drying Testing

4.4.1 Particle Size Analysis

• After spray drying, collect a sample of the powder and test the particle size distribution using a particle size analyzer.

4.4.2 Moisture Content Testing

• Test the moisture content of the powder to ensure it meets the target specifications.

4.5 Packaging

4.5.1 Powder Collection

• Collect the spray-dried powder into sterilized containers.

4.5.2 Storage

• Store the collected powder in a controlled environment to maintain its stability.

4.6 Documentation

• Document all process steps, including the parameters used, particle size, and moisture content, in the batch manufacturing record (BMR).

5) Abbreviations, if any

• API: Active Pharmaceutical Ingredient
• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Particle Size and Moisture Content Log

7) References, if any

• FDA Guidance for Industry – Nasal Drug Products

8) SOP Version

Version 1.0

Annexure

Particle Size and Moisture Content Log Template

  

    
Date
    
Formulation
    
Particle Size Range (µm)
    
Moisture Content (%)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
Size Range
    
Moisture
    
Operator Name
    
QA Name