Standard Operating Procedure for Sample Collection for Quality Testing in Aerosols

1) Purpose

The purpose of this SOP is to establish procedures for the collection of samples during aerosol production for subsequent quality testing. Proper sample collection ensures representative samples are obtained for accurate analysis and compliance with quality standards.

2) Scope

This SOP applies to the sampling procedures conducted at [Company Name] for aerosol products, including sampling during manufacturing, packaging, and storage stages.

3) Responsibilities

Production Operators: Responsible for collecting samples as per sampling plan.
Quality Control (QC) Analysts: Perform testing on collected samples.
Quality Assurance (QA) Manager: Ensure compliance with sampling procedures and documentation.

4) Procedure

4.1 Sampling Plan:
4.1.1 Develop a sampling plan based on batch size, production stages, and critical process parameters.
4.1.2 Specify sampling points and frequency according to SOPs and regulatory requirements.

4.2 Sample Collection:
4.2.1 Follow aseptic techniques and appropriate sampling methods to avoid contamination.
4.2.2 Collect samples in clean, sterile containers, ensuring integrity and traceability of sample collection.

4.3 Sample Identification and Labeling:
4.3.1 Label each sample container with unique identifiers, including batch number, sampling location, and date/time of collection.
4.3.2 Record sample collection details in sampling logbooks or electronic systems.

4.4 Sample Transport and Storage:
4.4.1 Transport samples to the QC laboratory promptly and under controlled conditions to prevent degradation.
4.4.2 Store samples under appropriate storage conditions as specified in SOPs until testing is performed.

4.5 Documentation:
4.5.1 Maintain accurate records of sample collection activities, including deviations or incidents.
4.5.2 Document any observations or deviations noted during sample collection and handling.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Sampling Plan
Sampling Logbooks
Incident Reports (if applicable)

7) Reference, if any

GMP Guidelines
Pharmacopeial standards (e.g., USP, EP)

8) SOP Version

Version 1.0