Standard Operating Procedure for Weighing and Dispensing of Raw Materials for Lyophilization
1) Purpose
The purpose of this SOP is to establish the process for weighing and dispensing raw materials used in lyophilized product formulations, ensuring accuracy, consistency, and traceability of material usage as per Good Manufacturing Practices (GMP).
2) Scope
This SOP applies to the operators, quality control, and warehouse staff responsible for weighing and dispensing raw materials required in the lyophilization process, from receipt to production usage.
3) Responsibilities
- Operators: Responsible for accurate weighing and dispensing of raw materials according to batch records.
- Quality Assurance (QA): Responsible for verifying weights and ensuring the proper documentation.
- Warehouse Staff: Responsible for the safe storage and handling of raw materials before and after dispensing.
4) Procedure
4.1 Preparation for Weighing
The following steps are to be performed before the weighing process begins:
4.1.1 Material and Equipment Setup
- 4.1.1.1 Ensure all equipment, including balances, is calibrated and functional.
- 4.1.1.2 Check that the area is clean and ready for material dispensing.
- 4.1.1.3 Review the batch manufacturing record (BMR) for the required materials and quantities.
- 4.1.1.4 Wear appropriate personal protective equipment (PPE) before handling materials.
4.1.2 Raw Material Retrieval
- 4.1.2.1 Retrieve materials from storage based on the batch requirements.
- 4.1.2.2 Verify that the
batch number and identification code match the batch manufacturing record (BMR).
4.1.2.3 Bring materials to the designated dispensing area in labeled containers.
4.2 Weighing Process
4.2.1 Weighing Procedure
- 4.2.1.1 Zero the balance before placing any material on it.
- 4.2.1.2 Place the material in a clean container and record the weight on the balance display.
- 4.2.1.3 Ensure that the weight matches the required quantity as per the BMR, considering acceptable tolerances.
- 4.2.1.4 For multiple components, weigh each material separately and record the weights in the Weighing Logbook.
4.2.2 Cross-Verification
- 4.2.2.1 After weighing, the operator must sign off on the recorded weight in the logbook.
- 4.2.2.2 A QA personnel should verify and countersign the weight documentation.
- 4.2.2.3 Any discrepancies must be reported immediately, and materials should be re-weighed if necessary.
4.3 Dispensing Process
4.3.1 Dispensing to Production
- 4.3.1.1 Once weighed, dispense the material into the production container, ensuring it is clearly labeled with the batch number and material name.
- 4.3.1.2 Ensure that no cross-contamination occurs during the transfer of materials.
- 4.3.1.3 If partial quantities of raw materials are required, ensure that remaining materials are resealed and stored appropriately.
4.3.2 Documentation and Labeling
- 4.3.2.1 Record the dispensed material, batch number, and weight in the Dispensing Logbook.
- 4.3.2.2 All containers should be clearly labeled with the material name, batch number, and quantity.
- 4.3.2.3 QA must verify the labels and documentation before the materials are transferred to the production area.
4.4 Cleaning and Storage Post-Dispensing
Following the dispensing process, the weighing and dispensing area should be cleaned and materials stored as follows:
- 4.4.1 Clean the weighing area and equipment after each use to prevent cross-contamination.
- 4.4.2 Return any unused raw materials to their designated storage location, ensuring they are sealed and labeled properly.
- 4.4.3 Document the cleaning activities in the cleaning logbook for the weighing area and equipment.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- PPE: Personal Protective Equipment
- QA: Quality Assurance
6) Documents, if any
- Weighing Logbook
- Dispensing Logbook
- Cleaning Logbook
7) References, if any
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
- World Health Organization (WHO) Good Manufacturing Practices for Pharmaceutical Products.
8) SOP Version
Version 1.0
Annexure
Weighing Logbook Template
| Date | Material Name | Batch No. | Required Weight | Actual Weight | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Material Name | Batch Number | Weight in grams/kg | Weight in grams/kg | Operator Name | QA Initials |
Dispensing Logbook Template
| Date | Material Name | Batch No. | Dispensed Quantity | Production Batch No. | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Material Name | Batch Number | Quantity in grams/kg | Production Batch Number | Operator Name | QA Initials |