Standard Operating Procedure for Handling Raw Materials for Lyophilized Products
1) Purpose
The purpose of this SOP is to define the procedure for the receipt, identification, and storage of raw materials required for lyophilized products. This SOP ensures the quality and integrity of the raw materials during storage and prior to usage in production, adhering to Good Manufacturing Practices (GMP).
2) Scope
This SOP applies to all personnel involved in receiving, identifying, and storing raw materials used in the manufacturing of lyophilized pharmaceutical products, including operators, warehouse staff, and quality assurance teams.
3) Responsibilities
- Operators: Responsible for proper receipt and storage of materials according to the guidelines.
- Quality Assurance (QA): Ensures that raw materials meet quality standards and verifies documentation.
- Maintenance Team: Maintains storage conditions and equipment functionality for material handling.
4) Procedure
4.1 Receipt of Raw Materials
Upon receipt of raw materials, the following steps must be followed:
4.1.1 Inspection of Delivery
- 4.1.1.1 Inspect the delivery vehicle for cleanliness and integrity of packaging.
- 4.1.1.2 Check the accompanying documentation, such as Certificates of Analysis (CoA) and delivery notes.
- 4.1.1.3 Ensure that materials are not damaged or compromised during transit.
4.1.2 Verification and Identification
- 4.1.2.1 Verify the quantity and quality of the materials against the purchase order.
- 4.1.2.2 Label all incoming materials with a unique identification code that includes batch number, material name, and receipt date.
- 4.1.2.3 Record all relevant details in the raw material logbook.
4.2 Storage of Raw Materials
4.2.1 Storage Conditions
- 4.2.1.1 Store raw materials in designated areas, separated by type and status (quarantine, approved, rejected).
- 4.2.1.2 Maintain storage conditions as per the manufacturer’s recommendations (e.g., temperature and humidity).
- 4.2.1.3 Ensure that sensitive materials such as lyophilization agents are stored in temperature-controlled environments.
4.2.2 Inventory Control
- 4.2.2.1 Use a first-expiry-first-out (FEFO) system to manage inventory.
- 4.2.2.2 Keep a digital log of stock levels, including material receipt dates and batch numbers.
- 4.2.2.3 Regularly audit and reconcile inventory to avoid stock discrepancies.
4.3 Handling and Movement of Raw Materials
4.3.1 Handling Procedures
- 4.3.1.1 Use appropriate personal protective equipment (PPE) when handling materials to avoid contamination.
- 4.3.1.2 Minimize material handling and transfer materials with appropriate tools (e.g., forklifts or pallet jacks).
4.3.2 Quarantine and Sampling
- 4.3.2.1 Place all incoming raw materials into quarantine storage until they are sampled and approved by the quality control team.
- 4.3.2.2 Sample materials as per the sampling plan and transfer samples to the quality control laboratory for testing.
- 4.3.2.3 Release or reject materials based on the results of quality control testing.
4.4 Documentation
All steps must be documented meticulously. The following documents should be filled out and verified at each stage:
- 4.4.1 Raw Material Receipt Log
- 4.4.2 Material Identification and Labeling Records
- 4.4.3 Storage Condition Monitoring Logs
5) Abbreviations, if any
- GMP: Good Manufacturing Practices
- CoA: Certificate of Analysis
- QA: Quality Assurance
6) Documents, if any
- Raw Material Receipt Log
- Material Identification and Labeling Record
- Storage Condition Monitoring Log
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
Blending Process Logbook Template
| Date | Time | Operator Initials | Blending Duration | Remarks |
|---|---|---|---|---|
| DD/MM/YYYY | HH:MM | Operator Name | Duration in minutes | Process completed as per SOP |
Batch Manufacturing Record (BMR) Template
| Batch No. | Start Date | End Date | Blending Equipment | Operator Initials | Supervisor Signature |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | DD/MM/YYYY | Equipment Name | Operator Name | Supervisor Name |