1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish a Raw Material Traceability Procedure that will ensure the identification, tracking and documentation of raw materials used in production.
2. Scope: This SOP applies to all raw material suppliers, production personnel and QA personnel involved in the manufacturing process.
3. Responsibilities:
a. Raw material suppliers shall provide complete and accurate documentation for all raw materials delivered.
b. Production personnel shall verify the correctness of the raw materials delivered, and ensure that they are stored and labelled appropriately.
c. QA personnel shall verify the raw material documentation and ensure that they are traceable through the entire manufacturing process.
4. Procedure:
a. Upon delivery of raw materials, production personnel shall verify that the delivered raw materials match the documentation provided by the supplier. Any discrepancies shall be recorded and reported to QA.
b. Raw materials shall be labelled with the lot number, date received and expiration date.
c. Raw materials shall be stored in the designated areas, based on their classification and expiry date.
d. QA personnel shall perform a thorough verification of all raw material documentation before releasing the raw materials for production.
e. During production, production personnel shall ensure that the correct raw materials are used in accordance with the Bill of Materials (BOM) or formulation.
f. Any unused raw materials shall be returned to the designated storage area.
g. At the end of the production run, QA personnel shall verify that all raw materials have been used correctly and shall confirm the traceability of the raw materials through the entire manufacturing process.
5. Abbreviations used:
a. QA- Quality Assurance
b. BOM- Bill of Materials
6. Documents:
a. Raw Material Specification Sheet
b. Material Safety Data Sheet (MSDS)
c. Purchase Order
d. Certificate of Analysis (COA)
7. Reference:
a. ISO 9001:2015 Quality Management System
b. Good Manufacturing Practices (GMP)
c. Hazard Analysis and Critical Control Points (HACCP)
8. SOP Version: Raw Material Traceability Procedure SOP Version 1.0.