Standard Operating Procedure for Weighing and Dispensing of Raw Materials
1) Purpose
The purpose of this SOP is to ensure the accurate weighing and dispensing of raw materials used in the manufacturing of dental dosage forms to maintain product quality and consistency.
2) Scope
This SOP applies to all raw materials used in the manufacturing of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Production Department is responsible for the accurate weighing and dispensing of raw materials. The Quality Assurance (QA) Department is responsible for verifying and documenting the weighing and dispensing process.
4) Procedure
4.1 Preparation
4.1.1 Verify the identity and quality of raw materials before weighing and dispensing.
4.1.2 Ensure the weighing scales are calibrated and in good working condition.
4.1.3 Gather all necessary equipment, such as weighing scales, containers, and personal protective equipment (PPE).
4.2 Weighing
4.2.1 Place the container on the weighing scale and tare the scale to zero.
4.2.2 Carefully weigh the required quantity of raw material according to the batch record.
4.2.3 Record the weight of the material in the batch record and on the container label.
4.3 Dispensing
4.3.1 Transfer the weighed material to the designated production area using appropriate handling techniques.
4.3.2 Ensure that the material is dispensed into the correct production batch as per the batch record.
4.3.3 Label the container with the material name, batch number, and weight.
4.4 Documentation
4.4.1 Document all weighing and dispensing activities in the batch record.
4.4.2 Attach any relevant data, such as weighing scale printouts, to the batch record.
4.5 Approval
4.5.1 Submit the completed batch record to the QA Department for review and approval.
4.5.2 Store the approved batch record in the production documentation file.
5) Abbreviations, if any
PPE – Personal Protective Equipment
6) Documents, if any
Batch Record
Weighing Scale Calibration Records
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
8) SOP Version
Version 1.0
