Standard Operating Procedure for Raw Material Testing and Approval
1) Purpose
The purpose of this SOP is to establish the procedure for the testing and approval of raw materials to ensure they meet the required quality standards before being used in the manufacturing process.
2) Scope
This SOP applies to all raw materials received at [Company Name] for the manufacturing of intramuscular, subcutaneous, and intravenous injection products.
3) Responsibilities
The responsibilities of this SOP include:
– Quality Control (QC) Department: Conducting tests on raw material samples.
– Quality Assurance (QA) Department: Reviewing test results and approving raw materials for use.
– Warehouse Personnel: Handling and storing raw materials during the testing process.
4) Procedure
4.1 Sampling of Raw Materials
4.1.1 Upon receipt, raw materials are sampled according to the sampling plan.
4.1.2 Samples are labeled with the material name, batch number, and date of sampling.
4.2 Testing of Raw Materials
4.2.1 The QC Department conducts tests according to established methods and specifications.
4.2.2 Tests may include identity, purity, potency, and other relevant quality attributes.
4.2.3 Record all test results and observations in the laboratory notebook or electronic system.
4.3 Approval of Raw Materials
4.3.1 The QA Department reviews test results and compares them with the acceptance criteria.
4.3.2 If the raw materials meet the specified criteria, they are approved for use.
4.3.3 Approved materials are tagged with an “Approved” label and moved to the storage area.
4.3.4 If materials fail to meet the criteria, they are rejected and quarantined for further investigation or return to the supplier.
4.4 Documentation and Records
4.4.1 Maintain records of sampling, testing, and approval/rejection of raw materials.
4.4.2 All documentation must be signed and dated by the responsible personnel.
5) Abbreviations, if any
– QC: Quality Control
– QA: Quality Assurance
6) Documents, if any
– Sampling Plan
– Laboratory Notebook/Electronic System
– Test Methods and Specifications
– Approval/Rejection Tags
7) Reference, if any
– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
8) SOP Version
Version 1.0