Standard Operating Procedure (SOP) for Raw Material Release Procedure
1.0 Purpose:
The purpose of this standard operating procedure is to outline the procedure for the release of raw materials at the manufacturing facility. This SOP is intended to ensure the quality and safety of the raw materials used in the production process, as well as to comply with regulatory requirements.
2.0 Scope:
This SOP applies to all raw materials used in the manufacturing process at the facility. In addition, it applies to all personnel involved in the raw material release process.
3.0 Responsibilities:
1. Quality Assurance: Quality Assurance shall be responsible for ensuring that the raw materials meet the required specifications before they are released for use in production.
2. Warehouse Personnel: Warehouse personnel shall be responsible for managing the inventory of raw materials and ensuring that they are properly labeled, stored, and controlled.
3. Production Personnel: Production personnel shall be responsible for ensuring that the raw materials are properly identified, weighed, and verified before they are used in the manufacturing process.
4. Document Control: Document Control shall be responsible for maintaining records related to raw material release, such as purchase orders, certificates of analysis, and other relevant documentation.
4.0 Procedure:
1. Receipt of Raw Materials:
1.1 Upon receipt of the raw materials, the Warehouse personnel shall verify the identity, quantity, and condition of the materials against the accompanying purchase order.
1.2 Any discrepancies shall be reported to the Quality Assurance department for investigation.
1.3 The raw materials shall be stored in a designated location in the warehouse.
2. Review of Documentation:
2.1 The Quality Assurance department shall review the accompanying documentation for each raw material, including the certificate of analysis, to verify that the materials meet the required specifications.
2.2 If the raw materials do not meet the required specifications, they shall be rejected and returned to the supplier.
3. Sampling and Testing:
3.1 The Quality Assurance department shall take a representative sample from each lot of raw materials, as per the sampling plan.
3.2 The sample shall be tested for compliance with the required specifications, as per the established testing plan.
3.3 If the raw materials pass the required testing, the Quality Assurance department shall approve the release of the materials for use in production.
4. Release of Raw Materials:
4.1 Once the raw materials have been approved for release, a release note shall be issued by the Quality Assurance department.
4.2 The release note shall be attached to the raw materials or entered into the ERP system.
4.3 Warehouse personnel shall release the approved raw materials to the production department, along with the corresponding release note.
5. Disposition of Non-Conforming Materials:
5.1 If raw materials are found to be non-conforming during any stage of the release process, they shall be identified as such and quarantined.
5.2 The Quality Assurance department shall investigate the non-conformance and determine the appropriate disposition of the materials, which may include disposal or return to the supplier.
6.0 Record Keeping:
6.1 All documentation related to the raw material release process, including purchase orders, certificates of analysis, testing results, release notes, and any other relevant documents, shall be filed and stored for a minimum of seven years.
6.2 The Document Control department shall be responsible for maintaining these records and ensuring their availability for inspection by regulatory authorities.
7.0 Training:
All personnel involved in the raw material release process shall receive appropriate training on this SOP and their respective roles and responsibilities.
8.0 Revision History:
This SOP shall be reviewed and updated as necessary to ensure its continued suitability and effectiveness. Any changes to the SOP shall be documented and communicated to all relevant personnel.