Key Notes on Revised Schedule M: Metered Dose Inhalers

Last Updated on March 15, 2025 by The Health Master

Metered Dose Inhalers

Key considerations for Metered Dose Inhalers for compliance under revised Schedule M are outlined below.

Continued from: Key Notes on Revised Schedule M: Investigational Pharmaceutical Products

Good Manufacturing Practices for Metered Dose Inhalers

Manufacturing Metered Dose Inhalers (MDIs): A Comprehensive Guide

Key Points:

Unique Challenges:

As the nature of Metered Dose Inhalers (MDI) is pressurized, special manufacturing considerations are required; keeping in view the delicate nature of the active ingredient and maintaining sterility and product uniformity is critically important.

Manufacturing Methods:

Two-Shot System: The active ingredient is suspended in a high-boiling propellant, filled into the container, and then a lower-boiling propellant is injected through the valve.

One-Shot Process: The active ingredient is suspended in a propellant mixture and filled directly into the container in a single step.

Essential Conditions:

Cleanliness: The environment for manufacturing this drug must be specially maintained to prevent or minimize microbial and particulate contamination.

Environment control: A controlled environment must be strictly maintained in the manufacturing facility to ensure the quality of the Metered Dose Inhalers (MDI) with respect to the temperature, humidity, and air pressure.

Personnel hygiene: All the personnel involved in the various manufacturing processes of the Metered Dose Inhalers (MDI) must strictly follow the hygiene protocols, including wearing suitable and appropriate protective clothing and sterile gloves.

Equipment:

Closed Systems: Manufacturing equipment must be designed and installed in the closed system to minimize contamination.

Validation: All equipment involved in the manufacturing process must be regularly validated and calibrated, e.g., spray testers, filling machines, and checking of weighers.

Segregation: The manufacturing area must be segregated into various distinct zones for different stages of manufacturing of the Metered Dose Inhalers (MDI), e.g., preparation of the containers, bulk preparation, filling and packing of the product, and quality control of the product.

Quality Assurance:

Quality Controls: Quality control of the Metered Dose Inhalers (MDI) is a must during in-process and quality testing of the final product, including checks on weight, leakage, and spray performance.

Supplier Audits: Auditing is a must for the quality systems of valve manufacturers to ensure the integrity of the final Metered Dose Inhalers (MDI).

Documentation:

Detailed documentation is required with respect to the various manufacturing processes, including records of environmental control, in-process control, quality checks of the final Metered Dose Inhalers (MDI), and its release.

Compliance with Revised Schedule M:

GMP:

All manufacturing activities must strictly follow the principles of the Good Manufacturing Practices (GMP) principles mentioned in Schedule M.

Risk Assessment:

Risk assessments must be assessed to identify potential hazards and implement strict measures for quality control.

Validation of processes:

Manufacturing processes must be validated periodically, e.g., manufacturing processes, cleaning procedures, filling operations, and analytical methods involved in the testing of the Metered Dose Inhalers (MDI).

Improvement:

The manufacturers must implement a robust quality management system, including continuous improvement initiatives keeping in mind the quality of the Metered Dose Inhalers (MDI) and manufacturing efficiency.

Training:

All personnel involved in Metered Dose Inhalers (MDI) manufacturing must be trained periodically with respect to GMP requirements, SOPs, and safety protocols.

Audits:

The manufacturers must conduct regular internal and external audits to review the compliance with Schedule M and identify areas for improvement.

By following the guidelines and implementing the requirements mentioned in the revised Schedule M, pharmaceutical manufacturers can manufacture the safe and effective Metered Dose Inhalers (MDI) with high quality.

Please note: This information is for general guidance only and may not be exhaustive. Refer to the official regulations and any applicable guidance documents for specific requirements and interpretations.

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Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

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Next: Key Notes on Revised Schedule M: API Part-1 ….coming soon

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