Standard Operating Procedure for Sample Collection for Quality Testing in Lotions

1) Purpose

The purpose of this SOP is to define procedures for the collection of samples from lotion production batches for subsequent quality testing and analysis.

2) Scope

This SOP applies to all personnel involved in the collection, handling, and submission of samples for quality testing within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Production Personnel:

• Collect representative samples from lotion production batches according to approved sampling plans.
• Ensure samples are properly labeled, identified, and transported to the testing laboratory.

Quality Control (QC) Analysts:

• Receive and verify sample integrity upon receipt in the laboratory.
• Perform required quality tests and analyses on collected samples.

Quality Assurance (QA) Personnel:

• Verify compliance with sampling procedures and documentation requirements.
• Review and approve sample collection records and testing results.

4) Procedure

4.1 Sampling Plan:

• Refer to approved sampling plan or batch record to determine sample collection points and quantities.
• Identify critical sampling locations and ensure representative samples are obtained.

4.2 Sample Collection:

• Use appropriate sampling tools and techniques to collect samples aseptically or under controlled conditions.
• Label each sample container with batch information, sampling location, and date/time of collection.

4.3 Sample Handling:

• Transport samples to the designated testing area promptly and under suitable storage conditions to prevent degradation.
• Store samples temporarily if necessary, following approved storage requirements.

4.4 Documentation:

• Document sample collection activities, including details of sampling points, procedures followed, and any deviations encountered.
• Complete sample collection records and ensure accuracy and completeness of information.

4.5 Sample Submission:

• Submit collected samples to the QC laboratory along with accompanying documentation and sample identification details.
• Notify QC analysts of sample arrival and provide necessary information for testing.

5) Abbreviations, if any

SOP: Standard Operating Procedure

QC: Quality Control

QA: Quality Assurance

6) Documents, if any

• Sampling Plan
• Sample Collection Records
• Batch Records

7) Reference, if any

• USP <1058>: Analytical Instrument Qualification
• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0