Standard Operating Procedure for Raw Material Handling and Sampling in Otic Manufacturing Unit
1) Purpose
To establish procedures for the receipt, identification, handling, storage, and sampling of raw materials used in the manufacturing of Otic (Ear) Dosage Forms to ensure quality, traceability, and compliance with regulatory standards.
2) Scope
This SOP applies to all personnel involved in the handling and sampling of raw materials within the manufacturing facility.
3) Responsibilities
Warehouse Personnel: Responsible for receiving, storage, and labeling of raw materials.
Quality Control (QC) Department: Responsible for sampling and testing of raw materials.
Production Supervisors: Responsible for coordinating with QC for timely sampling and release of raw materials for production.
4) Procedure
4.1 Receipt of Raw Materials
4.1.1 Inspection
4.1.1.1 Upon receipt, visually inspect all incoming raw materials for integrity and packaging.
4.1.1.2 Verify shipment against accompanying documents (e.g., Certificate of Analysis, packing list).
4.1.2 Sampling
4.1.2.1 Randomly sample raw materials according to sampling plan and procedures.
4.1.2.2 Use appropriate sampling tools and techniques to minimize contamination.
4.2 Identification and Labeling
4.2.1 Labeling
4.2.1.1 Label each container of raw material with unique identifiers, including name, lot number, and expiration date.
4.2.1.2 Affix “Quarantine” label until raw materials are tested and released.
4.2.2 Storage
4.2.2.1 Store raw materials under appropriate conditions as per storage requirements specified in SOP.
4.2.2.2 Ensure segregation of different materials to prevent cross-contamination.
4.3 Sampling Procedure
4.3.1 Sample Preparation
4.3.1.1 Prepare samples in accordance with sampling plan and specific requirements for each material.
4.3.1.2 Document sample size, location, and handling procedure.
4.3.2 Testing
4.3.2.1 Transfer samples to QC laboratory for testing as per approved test methods.
4.3.2.2 Await test results before releasing raw materials for production.
4.4 Rejection and Disposal
4.4.1 Rejection Criteria
4.4.1.1 Reject raw materials that do not meet acceptance criteria based on testing results.
4.4.1.2 Initiate supplier notification and documentation for rejected materials.
4.4.2 Disposal
4.4.2.1 Arrange for proper disposal of rejected or expired raw materials as per SOP.
4.4.2.2 Document disposal activities and maintain records.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
GMP: Good Manufacturing Practices
6) Documents, if any
Certificate of Analysis
Sampling plan
Raw material inspection records
7) Reference, if any
GMP guidelines for handling and sampling of raw materials in pharmaceutical manufacturing
8) SOP Version
Version 1.0
