Key Notes on Revised Schedule M: API Part-3

Last Updated on April 10, 2025 by The Health Master

API Part-3

Key notes for API Part-3 for compliance under revised Schedule M are outlined below.

Continued from: Key Notes on Revised Schedule M: API Part-2

Good Manufacturing Practices for API Part-3

Manufacturing API Part-3: 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-3

Key Points

• Comprehensive Documentation:

All manufacturing documents (procedures, reports and specifications) must be well documented, well-defined, reviewed, approved, and readily accessible.

A robust system for document control is very important, including distribution and revision history.

Retain all documents related to development, production, control, and distribution for specified periods, at least one year after the expiry date as laid down in the regulations.

• Accuracy and integrity must be documented.

All records must be documented with clear identification of the technical staff making the entry.

Corrections, if any, should be made properly, ensuring the original entry remains legible in the documents.

All the records can be maintained in hard copy or electronically, with proper retrieval mechanisms must be in place.

• Material Management:

Establish and follow written procedures for receiving, identifying, quarantining, storing, and handling all materials.

Proper evaluation and approval of suppliers of critical raw materials must be there.

Implement a system to prevent cross-contamination during material handling and storage.

• Master Production Instructions:

Detailed and approved master production instructions (MPIs) must be in place for each intermediate and API.

MPIs should include a proper list of all raw materials, manufacturing processes, in-process controls, and expected yields of the product.

• Batch Production Records:

Complete, accurate, and proper batch production records for each intermediate and API must be maintained.

These records should include all important parameters of the manufacturing process, in-process test results, deviations, and investigations.

• Laboratory Controls:

Complete laboratory control records are very important, including all testing data, testing analytical methods, and timely calibration of all the laboratory instruments.

Thorough investigation of any out-of-specification (OOS) results.

• Review and Approval of Batch Record:

A strong system for reviewing and approving all batches related to production and laboratory control records must be in place before releasing the batch.

Quality units should review and approve critical process steps.

• Storage of materials:

Store all materials in such a manner to ensure the prevention of degradation, contamination, and cross-contamination.

Implement proper storage conditions to maintain material quality and prevent adverse effects.

Follow the “first-in, first-out” (FIFO) principle for material usage.

Establish a quarantine system for rejected materials to prevent their unauthorized use.

• Material Re-evaluation:

Re-evaluate materials as needed (e.g., after prolonged storage) to ensure their suitability for use.

Note: This is a summary, and manufacturers should carefully review the full text of Schedule-M Part XII for detailed guidance and specific requirements.

Disclaimer: This information is for general knowledge and informational purposes only and does not constitute legal or professional advice.

Please note: This information is for general guidance only and may not be exhaustive. Refer to the official regulations and any applicable guidance documents for specific requirements and interpretations.

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

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Next: Key Notes on Revised Schedule M: API Part-4 ….coming soon

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