1.0 Objective:
To establish a procedure for labeling and identifying raw materials in the manufacturing process to ensure their traceability, proper storage, and product quality.
2.0 Scope:
This standard operating procedure (SOP) applies to all raw materials used in manufacturing at the company premises.
3.0 Responsibilities:
All personnel engaged in the labeling, movement, and storage of raw materials must follow this SOP. The Quality Assurance (QA) team and the Production Manager are responsible for enforcing compliance.
4.0 Procedure:
1) Raw material labeling requirements:
a) Each raw material must have a unique identification number.
b) The identification number must be clear, legible, and placed in a visible area on the container or bag.
c) All information on the label must be in English.
2) The following information must be included on the label:
a) Raw material name and batch number.
b) Date of manufacture and expiration date (if applicable).
c) Supplier name and contact details.
d) Storage conditions required such as temperature, humidity, light exposure, etc.
3) Labeling Process:
a) Upon receipt of raw materials, the QA team shall inspect each container and verify if it meets the labeling requirements.
b) In case the raw material is not appropriately labeled, QA will immediately communicate with the supplier for necessary corrective actions.
c) The QA team shall stamp its approval on each label. If a label is unreadable, QA shall reproduce a new label.
4) Placing Raw Materials in Storage:
a) The production team shall place the raw material in its designated storage location.
b) Storage location must be well labeled, with a unique identification number.
c) Storage conditions requirements must be met, based on the information provided on the label.
d) The team leader, along with the QA team, must confirm that the raw material is placed appropriately in storage, and the labeling requirements are met.
5) Accessing Raw Materials:
a) Only authorized personnel are allowed to access the raw material storage area.
b) Before removing any raw material, the production team leader shall verify that the identification number on the label corresponds to the requisition form.
c) In case of damaged or unreadable label, QA must be informed, and the raw material must not be used until a new label is appropriately put in place.
5.0 Record Keeping:
All raw material movement must be documented, including all incoming and outgoing storage details, production usage details, and disposal of unused material.
6.0 Conclusion:
This SOP outlines the procedure for raw material labeling to ensure proper storage, traceability, and product quality. Proper implementation of this SOP will ensure compliance with the regulatory requirements and promote accuracy in the manufacturing process.