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

Last Updated on January 5, 2025 by The Health Master

Tablets & Capsules

Key considerations for Tablets & Capsules (OSDF) for compliance under revised Schedule M are outlined below.

Continued from: Key Notes on Revised Schedule M: Point No. 20 – Computerised systems

Pharma Manufacturer Compliance Checklist for Tablets & Capsules i.e. Oral Solid Dosage Forms (OSDF)

General Requirements:

Dust Control and Cross-Contamination:

• Implement enclosed dust control systems where necessary.
• Maintain suitable environmental conditions (air conditioning, air extraction).
• Use metal detectors and avoid wooden equipment.
• Sieve ingredients before use.
• Monitor and maintain pressure differentials between rooms.
• Prevent material lodging in equipment.
• Segregate different products during manufacturing.
• Establish a pressure cascade system to control airflow.
• Calibrate and qualify pressure control and monitoring devices.
• Utilize airlocks to limit cross-contamination.

• Implement appropriate temperature and humidity control measures.
• Remove dust and vapor contamination at the source.
• Filter exhaust air to prevent environmental contamination.
• Design and operate fume, dust, and effluent control systems to prevent contamination.
• Implement appropriate airlock and changing room procedures.
• Maintain detailed diagrams of pressure cascades and airflow routes.

Specific Requirements for Processing:

Sifting, Mixing, and Granulation:

• Use dust extraction or dedicated areas for mixing and sifting.
• Monitor and record critical operating parameters.
• Prevent contamination in fluid-bed driers.
• Minimize the risk of microbial growth in granulation and coating solutions.

Compression (Tablets):

• Use dust control facilities on compression machines.
• Prevent mix-up of materials and tablets.
• Monitor tablet weight variation and other quality parameters.
• De-dust tablets and collect them in clean containers.
• Implement in-process control to ensure product quality.

Coating (Tablets):

• Use filtered air for coating pans.
• Control environmental conditions.
• Minimize microbial growth in coating solutions.

Filling of Hard Gelatin Capsules:

• Store empty capsules under appropriate conditions.

Printing (Tablets and Capsules):

• Prevent product mix-up during printing.
• Use edible-grade colors and suitable printing ink.
• Quality control approval required after printing.

Packaging (Strip and Blister):

• Remove “rogue” tablets, capsules, or foils before new packaging operations.
• Minimize cross-contamination during packaging of uncoated tablets.
• Inspect strips for defects.
• Test packaging integrity for leak-proofness.

---

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

---

Next: Key Notes on Revised Schedule M: Oral Liquids

For informative videos by The Health Master, click on the below YouTube icon:

• Ease of living and doing business by providing compounding of offences: D&C Act
  January 5, 2025
• Fire at Pharma Plant of RPG Life Sciences: Mumbai
  January 5, 2025
• Key Notes on Revised Schedule M: Oral Liquids
  January 5, 2025
• Extension the deadline for Revised Schedule M: Draft notification
  January 4, 2025
• Key Notes on Revised Schedule M: Tablets & Capsules (OSDF)
  January 4, 2025
• Retail sale: Can we think ‘Pharmacist as Partner’ ?
  January 3, 2025

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

For informative videos on consumer awareness, click on the below YouTube icon: