SOP for Internal Labeling Procedure

OBJECTIVE

To lay down a procedure for internal labeling.

SCOPE

This procedure applies to the Warehouse Department of Pharmainfo Limited.

RESPONSIBILITY

• Raw material warehouse personnel to follow the procedure.
• The quality control chemist is responsible for the execution of the procedure.
• Warehouse In-Charge to ensure compliance.

PROCEDURE

• All materials before testing shall be labeled by the Q.C. department with a white ‘TO BE SAMPLED’ label. The label shall carry the material name, batch no., and code no. Manufacturer/supplier, mfg. date, exp. date, net quantity of material, invoice/delivery no. date of receipt container no. and the total number of containers.
• Materials sampled shall be labeled with a blue “SAMPLED” label. This shall go on only containers sampled. The rest of the materials of the same batch shall be labeled with Yellow ‘UNDER TEST LABEL’. Labels shall carry the following: material name, code number, date of sampling, total no. of containers, the person who sampled, and date of sampling.

• After analysis/inspection, approved materials shall be assigned a raw material no./ analytical report no. and labeled with a “PASSED” label. This green label shall have this information: material name, code no., batch no., raw material no., mfg. date, exp. date, Q.C. Approval & re-test date.

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• On issuance of raw materials for production, each material weighed shall be labeled with the white raw material slip, to avoid mix-up before production. This shall bear the following information: name of the material, code no, approved material number, product for which the material is going to be used, its code, and its batch no. and size. The gross, tare, and net weight, the person who weighed, & people who checked one from production another for Q.C. dept. and the Stores manager.
• At each stage of manufacturing & packaging, the area shall be labeled with a white ‘IN-PROCESS’ label. The same label shall go on every machine and utensil containing the in-process material. This label shall contain the following: date, product code no, product name, batch no., batch size, mfg. date, exp. date, container/ machine no., status, and the signature of the department in charge.
• Rejected materials shall be labeled with the red ‘REJECTED’ labels and the reason for rejection indicated, it shall carry the following information: Name of Material, Code No, and Batch No. Mfg. Date and Exp. Date & Quantity.
• Each machine, whether involved in the production or not, shall be labeled with a status label. This shall be white and with the following information:-Equipment cleaned / To be cleaned, previous product, machine no., batch no. date of cleaning, cleaned by and checked by, under maintenance.

REFERENCE

Nil.

ABBREVIATION

Q.A: Quality Assurance

Q.C: Quality Control

SOP: Standard Operating Procedure

No. : Number

W.H: Warehouse

ANNEXURE

Annexure No. - 1 -- To be sampled Label

Annexure No. - 2 -- Sampled Label

Annexure No. - 3 -- Under test Label

Annexure No. - 4 -- Passed Label

Annexure No. - 5 -- Rejected Label

REVISION HISTORY

Nil

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