Guidelines for Representative Sampling and Testing

1) Purpose

The purpose of this SOP is to outline the standardized procedures for taking representative samples of materials and products for testing and analysis to ensure their quality and compliance with specifications.

2) Scope

This SOP applies to all raw materials, in-process materials, and finished products within the pharmaceutical manufacturing facility.

3) Responsibilities

It is the responsibility of the Quality Control (QC) department to implement and follow this SOP. All personnel involved in sampling and testing must be trained on this procedure.

4) Procedure

1. Preparation for Sampling:
   1. Ensure all sampling tools and containers are clean and properly labeled.
   2. Wear appropriate personal protective equipment (PPE).
   3. Review the sampling plan and determine the number of samples required.
2. Sampling Process:
   1. Select the material or product to be sampled according to the sampling plan.
   2. Use appropriate sampling techniques to collect samples that are representative of the entire batch.
   3. Label each sample container with necessary details such as batch number, date, and type of material.
3. Sample Testing:
   1. Transfer samples to the laboratory under suitable conditions to avoid contamination or degradation.
   2. Perform required tests as per the specified methods and record the results.
   3. Compare test results against predefined acceptance criteria.
4. Documentation and Reporting:
   1. Document all sampling and testing activities in the appropriate logbooks and forms.
   2. Report any deviations or out-of-specification (OOS) results to the QC manager immediately.

5) Abbreviations, if any

PPE: Personal Protective Equipment

QC: Quality Control

OOS: Out-of-Specification

6) Documents, if any

Sampling Plan, Test Methods, Logbooks, and Sampling Forms

7) Reference, if any

Relevant regulatory guidelines such as ICH Q7 and FDA Guidance for Industry

8) SOP Version

Version 1.0