Standard Operating Procedure for Receiving and Storing Raw Materials

1) Purpose

The purpose of this SOP is to establish a procedure for the proper receipt and storage of raw materials to ensure their quality and integrity are maintained.

2) Scope

This SOP applies to all raw materials used in the manufacturing of pharmaceutical products within the facility.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Receiving Personnel:

Responsible for inspecting and documenting incoming raw materials.

3.2 Warehouse Staff:

Responsible for storing raw materials in designated areas under appropriate conditions.

3.3 Quality Control (QC) Personnel:

Responsible for sampling and testing raw materials to ensure compliance with specifications.

3.4 Quality Assurance (QA) Manager:

Responsible for overseeing the receipt and storage processes and ensuring compliance with regulatory requirements.

4) Procedure

4.1 Receipt of Raw Materials:

4.1.1 Verify the delivery against the purchase order and accompanying documentation.
4.1.2 Inspect the condition of the delivery, including packaging and labeling.
4.1.3 Document the receipt of materials, noting any discrepancies or damage.

4.2 Sampling and Testing:

4.2.1 QC personnel must sample raw materials according to the sampling plan.
4.2.2 Perform required tests to ensure materials meet specified quality standards.
4.2.3 Document testing results and release materials for use if they meet specifications.

4.3 Storage of Raw Materials:

4.3.1 Store raw materials in designated areas according to their storage requirements (e.g., temperature, humidity).
4.3.2 Label storage areas clearly with material name, batch number, and expiration date.
4.3.3 Monitor storage conditions regularly to ensure they remain within specified limits.

4.4 Inventory Management:

4.4.1 Maintain accurate inventory records for all raw materials.
4.4.2 Use a first-in, first-out (FIFO) system to ensure older materials are used first.
4.4.3 Conduct regular inventory audits to verify quantities and condition of stored materials.

5) Abbreviations, if any

QC – Quality Control
QA – Quality Assurance

6) Documents, if any

1. Purchase Orders
2. Receiving Logs
3. Sampling Plans
4. QC Test Reports
5. Inventory Records

7) Reference, if any

1. FDA Guidance on Good Manufacturing Practices (GMP)
2. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0