Key Notes on Revised Schedule M: Oral Liquids

Key considerations for Oral Liquids for compliance under revised Schedule M are outlined below.

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Key Notes Revised Schedule Oral Liquids
Key Notes Revised Schedule Oral Liquids
Rakesh Dahiya

Last Updated on January 6, 2025 by The Health Master

Oral Liquids

Key considerations for Oral Liquids for compliance under revised Schedule M are outlined below.

Continued from: Key Notes on Revised Schedule M: Tablets & Capsules (OSDF)

Pharma Manufacturer Compliance Checklist for Oral Liquids

(Syrups, Elixirs, Emulsions and Suspensions)

Building and Equipment:

  • Design and Maintenance: To minimize the cross-contamination and mix-ups in the oral liquid manufacturing section, the manufacturers must design the section and place the equipment in such a way to minimize the cross contamination. Further, maintain the section accordingly.
  • Closed Systems: To protect the products from contamination the firm must use the closed systems for the manufacturing and transfer the products.
  • Ventilation: Filtered air must be used for ventilation in the production areas where products are exposed during manufacturing process.
  • Airlock Entry: The firm must provided the double door airlock entry made the section fly-proof.
  • Drainage: Appropriate drainage systems must be provided to prevent backflow in the section. Also ensure proper cleaning and disinfection.
  • Cleaning and Sanitization: Regular clean and sanitize the production areas after each and every process of batch production.
  • Design of Equipment: To prevent the microbial growth and cross-contamination in the production area, the equipment should be so designed which are easy for cleaning, sanitization.
  • Selection of material: Equipment parts, which are direct in the contact of products, should be made up of stainless steel or any other appropriate materials. Also avoid glass parts in the equipment.
  • Cleaning of container: To clean containers, closures, and droppers, devices or machines with high-pressure air, water and steam jets should be used.
  • Quality of Bulk Material: Always make a quality check on bulk materials before transferring to another vessels or storage tanks in the production area.
  • Transfer of material: Always transfer accurate and measured material using the proper piple-line or any other suitable method.
  • Furniture quality: Stainless or any other appropriate material furniture must be used which is smooth, washable, and scratch-proof.

Purified Water:

  • Quality Monitoring: Chemical and microbiological quality of purified water should be specified and monitored regularly. Testing must be performed with respect to pathogens and total microbial count.
  • procedures of water system: Written procedures must be prepared to operate and maintain the purified water system. appropriate measures must be taken to prevent microbial proliferation (e.g., UV treatment, recirculation, heat treatment, sanitizing agents).
  • Flushing and Sanitization: To remove residual agents, always flush the water system after performing the chemical sanitization.

Manufacturing process:

  • Personnel: The personnel working in manufacturing area, must wear non-fiber shedding clothing to prevent the contamination of the product.
  • Handling of Material: Fiber-shedding materials storing the material should not be used (e.g., gunny bags, wooden pallets).
  • Homogeneity of product: Homogeneity of the product to be maintained during filling, especially take care at the beginning, end and after interruptions.
  • Primary Packaging: Filtered air (level-3 filters or higher) to be supplied in the primary packaging area. Maintain a temperature below 30 degrees Celsius.
  • Storage of Bulk Product: Maximum storage time and conditions for bulk product must be specified and the same should be mentioned in the Master Formula. Validation of the maximum storage time must be done.

Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana


Next: Key Notes on Revised Schedule M: Topical Products (External Preparations) ….coming soon

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