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
4.4.2 Maintain traceable documentation of sample collection activities.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
– Sample Collection Records
– SOP for Sampling Plan Development
– Batch Documentation Forms
7) Reference, if any
– FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– Company-specific sampling and testing guidelines
8) SOP Version
Version 1.0
