Standard Operating Procedure for Sampling and Testing of Raw Materials in Ointment Formulation

1) Purpose

The purpose of this SOP is to describe the procedures for the sampling and testing of raw materials used in ointment formulation to ensure they meet predefined quality standards before being used in the production process.

2) Scope

This SOP applies to all raw materials received for use in the ointment formulation process. It covers the procedures from sampling, testing, and approval/rejection of materials.

3) Responsibilities

– Quality Control (QC): Responsible for performing sampling and testing of raw materials, and for documenting and approving or rejecting materials based on test results.
– Quality Assurance (QA): Responsible for reviewing and ensuring compliance with the SOP and regulatory standards.
– Warehouse Staff: Responsible for handling and providing access to raw materials for sampling.

4) Procedure

1. Sampling of Raw Materials:
1.1 Preparation for Sampling:
1.1.1 Verify the identity of the raw material batch to be sampled.
1.1.2 Gather sampling tools and ensure they are clean and sterilized.
1.1.3 Wear appropriate personal protective equipment (PPE).
1.2 Sampling Process:
1.2.1 Follow aseptic techniques to avoid contamination.
1.2.2 Take representative samples from different parts of the container to ensure uniformity.
1.2.3 Seal and label samples with material name, batch number, and sampling date.

Testing of Raw Materials:
2.1 Preparation for Testing:
2.1.1 Prepare the testing environment and ensure all equipment is calibrated.
2.1.2 Verify test methods and reference standards.

2.2 Conducting Tests:
2.2.1 Perform tests according to the defined test methods (e.g., physical, chemical, microbiological tests).
2.2.2 Record all test data accurately and promptly.

Approval or Rejection of Raw Materials:
3.1 Review of Test Results:
3.1.1 QC reviews test results against predefined specifications.
3.1.2 Document any deviations and investigate their causes.

3.2 Decision Making:
3.2.1 Approve materials that meet all specifications and release them from quarantine.
3.2.2 Reject materials that do not meet specifications and document the reasons for rejection.

Documentation and Records:
4.1 Maintain comprehensive records of all sampling and testing activities.
4.2 Ensure that all documentation is complete, accurate, and stored securely.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– PPE: Personal Protective Equipment
– SOP: Standard Operating Procedure

6) Documents, if any

– Sampling Records
– Testing Protocols and Methods
– Test Result Logs
– Raw Material Specifications

7) Reference, if any

– FDA Guidance for Industry: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
– ISO 2859: Sampling Procedures for Inspection by Attributes

8) SOP Version

Version 1.0