Key Notes on Revised Schedule M: API Part-5

Key Notes on Revised Schedule M: API Part-5. Schedule M Part XII: manufacturing and Control of Active Pharmaceutical Ingredients (APIs)

Rakesh Dahiya

May 20, 2025

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Key Notes on Revised Schedule M: API Part-5

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Rakesh Dahiya

Asstt. State Drugs Controller |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com

API Part-5

Key notes for API Part-5 for compliance under revised Schedule M are outlined below.

Continued from: Key Notes on Revised Schedule M: API Part-4

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Good Manufacturing Practices for API Part-5

Manufacturing API Part-5: A Comprehensive Guide

Navigating Schedule M Part XII: Essential Documentation and Record-Keeping for API

Let’s understand Schedule-M Part XII: A Guide for Active Pharmaceutical Ingredients (API) Manufacturing.

Schedule-M Part XII gives the specific requirements for Good Manufacturing Practices (GMP) guidelines for the manufacturing of Active Pharmaceutical Ingredients in India.

This specific article gives the details for ensuring the quality, safety, and efficacy of APIs used in the manufacturing of pharmaceutical products.

Key Notes on Revised Schedule M: API Part-5

Schedule M Part XII: manufacturing and Control of Active Pharmaceutical Ingredients (APIs)

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Key Points:

Schedule M revised requirements: API Part- 5.

Schedule-M Part- XII: Additional requirements for manufacture of Active Pharmaceutical Ingredients (APIs in India)

This article covers additional requirements for the manufacture of Active Pharmaceutical Ingredients (APIs) in India.

Considerations addressed with regard to API:

Storage & Warehousing:

Proper storage conditions available and maintained, such as temperature/humidity controlled situations, etc.
Separate storage for quarantined, rejected, returned, or recalled materials.
Recommended transport/stores through sanctioning maintain condition.
Special conditions for stable storage should be noted or ensured for transporters.
Effective shipping/transfer accountability for distribution/recalls, etc.
Where the material needs to be shipped or transferred should be clearly known.

Laboratory Controls:

Independent quality units should have a separate lab.
The quality lab should be properly conditioned.
Written policy/procedures exist in terms of sampling/testing material approval/rejection of API/any materials, etc.
Written specifications, sampling plan, and test procedures, all based on scientific rationale. Supported by registration/filing documents.
Specifications should exist for APIs and components of APIs. Impurity profiles are documented, and testing criteria for IC/tested and microbiology quality limits should be determined and understood.
Out-of-control laboratory incidents should be documented and understood with the following analyses.
Quality units must have quality reagents and proper reference standards.

Intermediates & Active Ingredients Tested:

Each batch of intermediates and APIs tested for specifications compliance in the lab.
Impurity profiles are established, as a change in the process leads to a change in the API (determine the potential outcomes).
Each batch undergoes microbiological testing per requirement.

Certificate of Analysis:

Each batch of intermediates or of independent API must issue a certificate of analysis per demand.
Certificates need nomenclature, batch number, release date, expiration date, and results.
Certificate presentations should be signed by adequately competent supervisory personnel in quality units.

Stability Testing:

Stability testing is required to confirm proper storage conditions and retest expiration dating and program effectiveness.
Stability samples held in containers. Containers should replicate market containers.

Retest/Expiration Dating:

Expiration/retention dating should be based on stability data, connected through proper testing over time; preliminary testing may provide retest/expiration dating through scaled batches under identical conditions for a period of time.