In-process Testing Procedures for MDIs

1) Purpose

The purpose of this SOP is to establish procedures for conducting in-process testing during the manufacturing of metered-dose inhalers (MDIs) to ensure product quality, identify deviations, and facilitate real-time adjustments.

2) Scope

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

3) Responsibilities

The responsibilities for this SOP include performing in-process tests, interpreting test results, documenting findings, and implementing corrective actions. Specific roles include:
Production Operators: Collect samples and perform initial testing as per procedures.
Quality Control Technicians: Conduct detailed testing and analysis of in-process samples.
Supervisors: Review in-process testing results and authorize adjustments as necessary.

4) Procedure

4.1 Sampling
4.1.1 Collect representative samples at specified stages of the production process.
4.1.2 Ensure samples are taken aseptically and in accordance with sampling plans.
4.2 Testing Procedures
4.2.1 Perform in-process tests as defined in approved test methods and protocols.
4.2.2 Use validated equipment and instruments for testing and analysis.
4.3 Acceptance Criteria
4.3.1 Compare test results against established acceptance criteria and specifications.
4.3.2 Determine compliance or deviation from acceptance criteria.
4.4 Documentation
4.4.1 Record in-process testing results, including test methods, equipment used, and test outcomes.
4.4.2 Document any deviations observed and initiate corrective actions as per established procedures.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure

6) Documents, if any

In-process testing protocols, test method validations, in-process testing records, and deviation reports should be maintained.

7) Reference, if any

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

8) SOP Version

Version 1.0