SOP Guide for Pharma

SOP on Raw Material Handling Record Procedure

1.0 Purpose:
The purpose of this Standard Operating Procedure (SOP) is to describe the process of Raw Material Handling Record Procedure to ensure that all raw materials are handled, tracked, recorded, and stored according to the company’s quality standards and regulations in a consistent and controlled manner.

2.0 Scope:

This SOP applies to all employees, contractors, and visitors who handle and manage raw materials at the company site.

3.0 Responsibilities:
1. The Quality Control unit is responsible for ensuring that the raw material handling record is maintained as per the SOP.
2. Production and warehouse personnel are responsible for handling and storing raw materials in accordance with the company’s procedures and requirements.

4.0 Procedure:
1. On receipt of raw materials, the warehouse personnel shall check the delivered quantity against the purchase order and other relevant documents to ensure, that the right product is received in the correct quantity.
2. All receipts must be documented in the inventory management system with the following details:
a. Date of the receipt
b. Quantity received
c. Supplier name
d. Batch or lot number
e. Expiry or re-test date, if applicable
3. The Quality Control unit shall perform a visual inspection of the received raw materials against the approved

specifications and release the material to the production area.
4. The production personnel shall document the dispensing of the raw materials in the Dispensing Form, which includes the following details:
a. Date of dispensing
b. Quantity dispensed
c. Product name and code
d. Batch or lot number of the raw material
e. Employee details who dispensed the raw materials
f. Approval signature of the production supervisor
5. The Dispensing Form along with the raw material is taken to the production area for processing.
6. After the production process, the finished goods are kept in the warehouse and labeled with appropriate details such as batch or lot number, product name, and expiry or re-test date (if applicable).
7. The Quality Control personnel shall inspect the finished product for compliance with specifications before release.
8. The Quality Control unit shall document the acceptance and release of finished goods in the Finished Product Handling Record, which includes the following details:
a. Name and code of the finished product
b. Batch or lot number of the finished product
c. Quantity produced
d. Approval signature of the Quality Control personnel
9. The Finished Product Handling Record shall be reviewed, approved, and stored by the Quality Control unit.

5.0 Maintenance of Records:
All records related to raw material handling, dispensing, production, and finished product handling shall be maintained by the Quality Control unit for a minimum of 2 years after the expiry date of the finished product.

6.0 Training:
All employees, contractors, and visitors involved in handling raw materials shall be trained on this SOP and its implementation.

7.0 Revision History:
This SOP shall be reviewed and updated as necessary to reflect changes in regulatory requirements, company procedures, or best practices. Any revision to this SOP shall be approved and communicated to all relevant stakeholders.

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