Sample Collection Procedures for Quality Testing in MDIs
1) Purpose
The purpose of this SOP is to establish procedures for the collection of samples during the manufacturing of metered-dose inhalers (MDIs) for subsequent quality testing to ensure product quality and compliance with specifications.
2) Scope
This SOP applies to all personnel involved in sample collection activities within the MDI production facility, including production operators, quality control technicians, and validation specialists.
3) Responsibilities
The responsibilities for this SOP include collecting representative samples, ensuring sample integrity, labeling samples, and documenting sample collection activities. Specific roles include:
Production Operators: Collect samples at designated stages of the manufacturing process.
Quality Control Technicians: Receive and log samples for testing in accordance with sampling plans.
Validation Specialists: Monitor sample collection procedures and ensure compliance with protocols.
4) Procedure
4.1 Sampling Planning
4.1.1 Define sampling points and frequencies based on production batch size and critical process parameters.
4.1.2 Develop sampling plans to ensure representative samples are collected throughout the production process.
4.2 Sample Collection
4.2.1 Collect samples aseptically and in accordance with established sampling procedures.
4.2.2 Ensure proper labeling of samples
4.3 Sample Handling and Storage
4.3.1 Transport samples to the designated testing area under controlled conditions to maintain sample integrity.
4.3.2 Store samples under appropriate conditions to prevent degradation or contamination.
4.4 Documentation
4.4.1 Document sample collection activities, including sampling points, quantities collected, and handling procedures.
4.4.2 Maintain sample logs and records for traceability and regulatory compliance.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
6) Documents, if any
Sampling plans, sample collection logs, sample handling procedures, and sample documentation records should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for sample collection and testing requirements in pharmaceutical manufacturing.
8) SOP Version
Version 1.0