Standard Operating Procedure for Sampling and Testing Raw Materials

1) Purpose

The purpose of this SOP is to establish a procedure for the sampling and testing of raw materials to ensure they meet specified quality standards before use in manufacturing.

2) Scope

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

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Quality Control (QC) Personnel:

Responsible for sampling and testing raw materials according to the established procedures.

3.2 Warehouse Staff:

Responsible for making materials available for sampling and testing.

3.3 Quality Assurance (QA) Manager:

Responsible for reviewing and approving sampling and testing procedures.

4) Procedure

4.1 Preparation for Sampling:

4.1.1 Identify the batch of raw materials to be sampled.
4.1.2 Ensure sampling equipment and containers are clean and suitable for use.
4.1.3 Wear appropriate personal protective equipment (PPE) during sampling.

4.2 Sampling Procedure:

4.2.1 Draw samples from different locations within the batch to obtain a representative sample.
4.2.2 Use aseptic techniques to prevent contamination during sampling.
4.2.3 Label samples clearly with material name, batch number, and date of sampling.
4.2.4 Document the sampling process, including the amount of sample taken and the sampling method used.

4.3 Testing of Samples:

4.3.1 Perform required tests on samples according to established testing methods and specifications.
4.3.2 Document test results, including any deviations or anomalies.
4.3.3 Compare test results with specified acceptance criteria to determine if the material meets quality standards.

4.4 Release or Rejection of Raw Materials:

4.4.1 Approve raw materials that meet specified quality standards for use in manufacturing.
4.4.2 Reject and quarantine materials that do not meet quality standards.
4.4.3 Document the final disposition of all tested materials.

5) Abbreviations, if any

QC – Quality Control
QA – Quality Assurance
PPE – Personal Protective Equipment

6) Documents, if any

1. Sampling Plans
2. Sampling Logs
3. QC Test Reports
4. Material Disposition Records

7) Reference, if any

1. FDA Guidance on Good Manufacturing Practices (GMP)
2. WHO Guidelines on Sampling of Pharmaceutical Products and Related Materials

8) SOP Version

Version 1.0