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

Label materials clearly with relevant information (name, batch number, status, expiry date).

Rakesh Dahiya

December 25, 2024

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

Table of Contents

Author
Recent Posts

Rakesh Dahiya

SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com

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

Follow us on WhtasApp Channel

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.

Click for Guidance documents for industry

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.

Click for Guidance documents for industry

Read or Download Revised Schedule M

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