Key Notes on Revised Schedule M: Topical Products (External Preparations)

Last Updated on January 7, 2025 by The Health Master

Topical Products (External Preparations)

Key considerations for Topical Products (External Preparations) for compliance under revised Schedule M are outlined below.

Continued from: Key Notes on Revised Schedule M: Oral Liquids

Good Manufacturing Practices (GMP) for Topical Products (External Preparations)

(Creams, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting Powders and Identical Products}

Pharma Manufacturers must:

Maintain a Controlled Environment for manufacturing:

• Provide an airlock entry to the manufacturing area in the facility.
• Provide insectocutors outside the airlock.
• Manufacturing area must be filtered and air-conditioned.
• Install a robust HVAC system in the facility.
• Install a good quality and efficient exhaust system to remove the contaminations in the manufacturing area.

Equipment Hygiene and Product Integrity:

• Equipment should be designed and maintained for prevention of any accidental contamination.
• provide suitable material for cleaning the equipment.
• Use Purified Water IP for the manufacturing of the drug.
• Always sieve the powders before use in the manufacturing of drugs.

Manufacturing and Packaging Processes:

• Separate the manufacturing and packing processes.
• Heating of vehicles and bases must be done in a separate mixing area using vessels made up of stainless steel.
• provide a separate packing section for primary packaging of the drug.

Additional points for Air Filtration:

Recirculated Air Systems:

• Install filtration system having multi stages e.g. primary, secondary, and tertiary filters (e.g., EN779 G4, F8, and EN1822 H13).

Fully Fresh Air Systems:

• Use primary and secondary filters (e.g., G4 and F8 or F9).

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: Sterile Products (Parenteral and Sterile Ophthalmic Preparations) ….coming soon

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