Standard Operating Procedure for Sample Collection for Quality Testing in Gels

1) Purpose

The purpose of this SOP is to establish procedures for the collection of samples from gel products for subsequent quality testing to ensure compliance with specifications and regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the collection of samples from gel products within the pharmaceutical manufacturing facility.

3) Responsibilities

Production Operators: Collect samples during designated stages of gel production.
Quality Control (QC) Analyst: Perform testing on collected samples as per this SOP.
Quality Assurance (QA) Team: Review and approve sample collection procedures and test results.

4) Procedure

4.1 Sampling Plan
4.1.1 Develop a sampling plan specifying sampling points, frequencies, and sample sizes.
4.1.2 Ensure samples are representative of the entire batch or lot.

4.2 Sample Collection
4.2.1 Collect samples aseptically using approved sampling tools and containers.
4.2.2 Record sample collection details including location, time, and person collecting the sample.

4.3 Sample Handling
4.3.1 Label each sample with unique identifiers and batch information.
4.3.2 Transport samples to the QC laboratory under appropriate storage conditions (e.g., temperature, light protection).

4.4 Documentation
4.4.1 Complete sample