Color Consistency Testing Procedures in MDIs

1) Purpose

The purpose of this SOP is to establish procedures for testing the color consistency of metered-dose inhalers (MDIs) to ensure uniform appearance and product quality.

2) Scope

This SOP applies to all personnel involved in color consistency testing activities within the MDI production facility, including quality control technicians, production supervisors, and packaging operators.

3) Responsibilities

The responsibilities for this SOP include conducting color consistency testing, interpreting test results, documenting findings, and ensuring compliance with specifications. Specific roles include:
Quality Control Technicians: Perform color measurements using standardized equipment and procedures.
Production Supervisors: Monitor color consistency during manufacturing and packaging operations.
Packaging Operators: Verify color quality during packaging and labeling processes.

4) Procedure

4.1 Sample Preparation
4.1.1 Select representative MDI samples from production batches for testing.
4.1.2 Ensure samples are handled under controlled lighting conditions to minimize color variation.
4.2 Color Measurement
4.2.1 Use spectrophotometers or colorimeters to measure color parameters (e.g., L*a*b* values).
4.2.2 Conduct measurements at multiple points on each MDI unit to assess color uniformity.
4.3 Acceptance Criteria
4.3.1 Compare color measurements against established color standards and acceptance criteria.
4.3.2 Evaluate deviations and assess impact on product appearance and quality.
4.4 Documentation
4.4.1 Record color consistency testing procedures, including equipment used and measurement locations.
4.4.2 Document test results, deviations observed, and any corrective actions taken.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure

6) Documents, if any

Color consistency testing protocols, test records, color standard references, and batch release certificates should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for color consistency testing requirements in pharmaceutical manufacturing.

8) SOP Version

Version 1.0