Standard Operating Procedure for Accurate Weighing and Dispensing of Raw Materials in Nasal Spray Formulations

1) Purpose

The purpose of this SOP is to outline the procedures for accurately weighing and dispensing raw materials required for the formulation of nasal sprays. This SOP ensures precision, compliance with quality standards, and traceability throughout the process.

2) Scope

This SOP applies to all personnel involved in the weighing and dispensing of raw materials used in nasal spray formulations at [Company Name]. This includes, but is not limited to, active pharmaceutical ingredients (APIs), excipients, and preservatives.

3) Responsibilities

• Operators: Ensure correct materials are weighed, and documentation is accurately maintained.
• Quality Assurance (QA): Verify the accuracy of the weighing and dispensing process and ensure proper documentation.
• Maintenance Team: Ensure that weighing and dispensing equipment is calibrated and in proper working order.

4) Procedure

4.1 General Requirements

The following general requirements must be followed during the weighing and dispensing process:

• All raw materials must be handled in compliance with Good Manufacturing Practices (GMP).
• Ensure that all necessary personal protective equipment (PPE) is worn before beginning the process.
• All weighing and dispensing must be performed in a controlled environment to avoid contamination.

4.2 Equipment Setup

4.2.1 Inspection

• Inspect the weighing balance and ensure it is clean, calibrated, and functioning correctly.
• Verify that the calibration log for the balance is up to date and signed off by the QA team.
• Ensure that the necessary containers and tools (scoops, spatulas) are cleaned and available for use.

4.2.2 Balance Calibration

• Before beginning the weighing process, the balance must be calibrated using standard calibration weights.
• Document the calibration on the equipment log sheet, ensuring traceability and compliance.

4.3 Weighing of Raw Materials

4.3.1 Material Identification

• Before weighing, identify the raw material using the material name, batch number, and supplier details.
• Cross-check the material against the approved batch manufacturing record (BMR) or material request form.

4.3.2 Weighing Procedure

• Place an appropriate clean container on the balance and tare the weight of the container.
• Slowly add the raw material into the container until the desired weight is achieved as per the formulation instructions.
• Ensure that the material weight matches the specified amount within an acceptable tolerance range (+/- 0.1% for critical materials).
• Once weighed, document the weight in the material weighing log, including the material name, batch number, and weight.
• Transfer the weighed material to a designated area for dispensing.

4.3.3 Documentation

• Ensure that all raw materials are logged in the raw material receipt logbook, with details such as material name, batch number, and weighed quantity.
• Each entry in the log must be signed off by the operator and verified by a second person (QA or supervisor).

4.4 Dispensing of Raw Materials

4.4.1 Preparation for Dispensing

• Ensure that the dispensing area is clean and ready for use. Check that all necessary tools and containers are available and clean.
• Confirm that the weighing of raw materials has been completed and that the correct amounts have been recorded.

4.4.2 Dispensing Procedure

• Transfer the weighed raw material into the appropriate dispensing containers, ensuring no contamination occurs.
• Document the dispensing process, including the container used, the quantity dispensed, and the operator’s initials.
• If the material is to be subdivided into smaller quantities, ensure that each portion is properly labeled with material details and batch numbers.

4.5 Post-Weighing and Dispensing Activities

4.5.1 Cleaning

• After the weighing and dispensing process is complete, clean all equipment and tools used.
• Document the cleaning in the equipment log and ensure the work area is free of any residues or contaminants.

4.5.2 Final Verification

• The QA department must verify that the correct raw materials have been weighed and dispensed, and that the documentation is complete.
• QA personnel must cross-check the material log with the BMR to ensure accuracy and compliance.

5) Abbreviations, if any

• API: Active Pharmaceutical Ingredient
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• PPE: Personal Protective Equipment
• GMP: Good Manufacturing Practices

6) Documents, if any

• Material Weighing Log
• Raw Material Receipt Log
• Batch Manufacturing Record (BMR)

7) References, if any

• Good Manufacturing Practices (GMP) Guidelines
• FDA Guidance for Industry – Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products

8) SOP Version

Version 1.0