Key Notes on Revised Schedule M: Point No. 14 – Materials

Last Updated on March 15, 2025 by The Health Master

Materials

Key considerations for Point No. 14 – Materials compliance under revised Schedule M are outlined below.

Continued from: Key Notes on Revised Schedule M: Point No. 13 – Equipment

To ensure compliance with Good Manufacturing Practices (GMP) for pharmaceutical products, manufacturers must adhere to the following principles regarding Materials:

Material Sourcing and Quality:

• Source materials (starting, packaging, gases, solvents, etc.) from approved suppliers.
• Prioritize direct sourcing from producers.
• Establish clear specifications for materials and discuss them with suppliers.
• Contractually agree on critical aspects of material production and control with suppliers.

Material Inspection and Quarantine:

• Inspect incoming materials for package integrity, label accuracy, and compliance with order.
• Quarantine materials upon receipt until released for use or distribution.
• Store materials under appropriate conditions to ensure quality and prevent contamination.

Water Quality:

• Validate water treatment systems to produce purified water meeting Pharmacopoeial standards.
• Use purified water for all operations except washing and cleaning, where potable water is acceptable.
• Store water in suitable tanks to prevent microbial growth and maintain quality.

Material Handling and Storage:

• Label materials clearly with relevant information (name, batch number, status, expiry date).
• Store materials in designated areas to ensure segregation and rotation.
• Handle materials carefully to prevent contamination and degradation.
• Implement procedures for dispensing and recording material usage.

Packaging Material Control:

• Control the purchase, handling, and storage of primary and printed packaging materials.
• Securely store printed materials to prevent unauthorized access and mix-ups.
• Issue packaging materials to designated personnel following approved procedures.
• Inspect packaging materials for quantity, identity, and conformity to packaging instructions.
• Ensure packaging materials comply with Pharmacopoeial requirements and are not reactive, additive, absorptive, or leachable.

Intermediate and Bulk Products:

• Handle intermediate and bulk products purchased as starting materials.
• Store intermediate and bulk products under appropriate conditions.

Finished Product Storage and Release:

• Quarantine finished products until final release.
• Store finished products under established conditions.
• Evaluate finished products and document release for sale.

Rejected and Recalled Products:

• Clearly mark and store rejected materials and products separately.
• Dispose of or reprocess rejected materials as approved.
• Identify and store recalled products securely.
• Assess returned products and take appropriate action (reissue, relabel, or destroy).

Reagents and Culture Media:

• Prepare reagents according to written procedures and label them with relevant information.
• Verify the suitability of culture media using positive and negative controls.

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Compiled by:
Rakesh Dahiya, Asstt. State Drugs Controller, FDA Haryana

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Next: Key Notes on Revised Schedule M: Point No. 15 – Reference Standards

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