Stabilizer Handling Procedures in MDI Production

1) Purpose

The purpose of this SOP is to establish procedures for the use of stabilizers in metered-dose inhaler (MDI) production to ensure product stability, efficacy, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the handling and use of stabilizers within the MDI production facility, including production operators, chemical engineers, and quality control technicians.

3) Responsibilities

The responsibilities for this SOP include handling stabilizers safely, monitoring their usage, conducting quality checks, and ensuring compliance with specifications. Specific roles include:
Production Operators: Handle and add stabilizers to MDI formulations according to approved procedures.
Chemical Engineers: Assess stabilizer compatibility and conduct quality assessments.
Quality Control Technicians: Verify stabilizer content and ensure adherence to specifications.

4) Procedure

4.1 Stabilizer Handling
4.1.1 Store stabilizers in controlled conditions and protect them from contamination.
4.1.2 Use accurate weighing and measuring techniques during stabilizer addition.
4.2 Mixing and Blending
4.2.1 Incorporate stabilizers into MDI formulations under controlled mixing conditions.
4.2.2 Ensure uniform distribution of stabilizers throughout the formulation.
4.3 Quality Checks
4.3.1 Perform in-process checks to verify stabilizer concentrations and ensure product consistency.
4.3.2 Conduct stability testing to assess the long-term effects of stabilizers on MDI formulations.
4.4 Documentation
4.4.1 Maintain records of stabilizer handling procedures, including batch records and quality control reports.
4.4.2 Document stability testing results, deviations observed, and any corrective actions taken.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure

6) Documents, if any

Stabilizer handling protocols, stability testing reports, batch records, and quality control documents should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for stabilizer use in pharmaceutical manufacturing and quality control.

8) SOP Version

Version 1.0