Standard Operating Procedure for Sample Collection for Quality Testing in Transdermal Patches
1) Purpose
The purpose of this SOP is to establish procedures for the collection of samples from transdermal patch batches for quality testing to ensure compliance with specifications and regulatory standards.
2) Scope
This SOP applies to sample collection activities conducted during the manufacturing, packaging, and quality control of transdermal patches within the facility.
3) Responsibilities
The Production and Quality Control (QC) Departments are responsible for executing sample collection activities as per this SOP. Quality Assurance (QA) personnel provide oversight to ensure adherence to procedures and regulatory requirements.
4) Procedure
4.1 Sampling Plan Development
- 4.1.1 Develop a sampling plan specifying the number of samples, sampling points, and sampling frequency based on batch size and critical process parameters.
- 4.1.2 Ensure sampling plan complies with regulatory guidelines and internal quality standards.
4.2 Sample Collection Process
- 4.2.1 Collect samples at defined stages of production, including raw materials, in-process, and finished product stages, as per the sampling plan.
- 4.2.2 Use validated sampling tools and techniques to ensure representative samples are obtained without contamination or degradation.
4.3 Sample Handling and Identification
- 4.3.1 Label each sample container with unique identifiers, including batch number, sampling location, date, and initials of the sampler.
- 4.3.2 Ensure proper storage and transportation conditions to maintain sample integrity until testing.
4.4 Documentation and Recordkeeping
- 4.4.1 Document all sample collection activities in batch records or sampling logs, including details of sample collection points, quantities, and any observations.
- 4.4.2 Maintain traceable records of sample handling, storage conditions, and chain of custody throughout the testing process.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Sampling Plan
Sample Collection Logs
Batch Records
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
USP General Chapters on Sampling
8) SOP Version
Version 1.0