SOP Guide for Pharma

SOP on Raw Material Record Keeping Procedure

1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the record keeping of raw materials received in our company.

2. Scope: This SOP shall be applicable to all employees involved in the receipt and storage of raw materials in our company.

3. Responsibilities:

3.1. Warehouse In-charge: The warehouse in-charge shall receive the raw materials and maintain the record of the receipt of raw materials.

3.2. Production In-charge: The production in-charge shall verify the quality of the raw materials received and approve the acceptance of the materials for further processing.

3.3. Quality Control Officer: The Quality Control Officer shall verify the quality of the raw materials and approve the acceptance of the materials for further processing.

4. Procedure:

4.1. Receipt of raw materials: The warehouse in-charge shall receive the raw materials and verify the packing list, purchase order, and quantity of the materials received.

4.2. Record keeping: The warehouse in-charge shall maintain a record of the receipt of raw materials including the name of the supplier, purchase order number, date of receipt, quantity received, batch number, and expiry date.

4.3. Quality verification: The production in-charge and the quality control officer shall verify the quality of the raw materials received and compare it with

the standards set for the materials.

4.4. Approval for processing: The production in-charge and the quality control officer shall approve the acceptance of the raw materials for further processing based on the quality verification.

4.5. Storage: The warehouse in-charge shall store the raw materials in a designated and labeled area that is clean, dry, and secure.

4.6. Stock reconciliation: The warehouse in-charge shall periodically reconcile the stock of raw materials with the record maintained to ensure that there are no discrepancies.

4.7. Disposal of raw materials: The warehouse in-charge shall dispose of any raw materials that are damaged, expired, or of inferior quality.

5. Documentation: All records related to the receipt and storage of raw materials shall be maintained by the warehouse in-charge. The records shall include the packing list, purchase order, receipt record, quality verification record, and stock reconciliation record.

6. References:
ISO 9001:2015 Quality Management System – Requirements
Good Manufacturing Practices (GMP) guidelines

7. Record Retention: The record of raw materials received shall be maintained for a minimum of 3 years or as per company policy.

8. Revision History: Any changes made in this SOP shall be documented as the revision history and shall follow the SOP on “Document and Record Control.”

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