Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Key Notes on Revised Schedule M: API Part-1 - March 15, 2025
- Key Notes on Revised Schedule M: Metered Dose Inhalers - February 16, 2025
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Last Updated on March 16, 2025 by The Health Master
API Part-1
Key notes for API Part-1 for compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Metered Dose Inhalers
Good Manufacturing Practices for API Part-1
Manufacturing API Part-1: A Comprehensive Guide
Let’s understand Schedule-M Part XII: A Guide for Active Pharmaceutical Ingredients (API) Manufacturering.
Schedule-M Part XII gives the specific requirements for Good Manufacturing Practices (GMP) guidelines for the manufacturing of Active Pharmaceutical Ingredients Part-1 (API Part-1) 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 Points:
Applicability and scope:
It applies for the manufacturing of APIs that are used in the manufacturing of finished pharmaceutical products.
It covers APIs being manufactured by means of applying various manufacturing and testing methods, i.e., chemical synthesis, extraction, fermentation, and cell culture.
Excludes vaccines, blood products, and certain other categories of drugs.
It gives the definition of “API starting material” and also gives the details about the point at which GMP requirements typically apply.
Quality ManagementSystem:
It gives the details about the importance of having an independent quality management system, i.e., clear roles and responsibilities of the technical staff involved in the activity.
It also highlights the role of an independent quality system, which is responsible for the product quality.
It also gives the details about the key responsibilities of quality management units, i.e., release or rejection of APIs, review of manufacturing records, and internal audits or inspections done at the facility.
Regular review of the quality of the product to assess the consistency of the process and identify areas where improvement is required.
Personnel Requirements:
Emphasizes the need for qualified and trained personnel.
Outlines requirements for personnel hygiene and appropriate attire.
Stipulates restrictions on activities that could compromise API quality, such as eating and smoking in production areas.
Requires qualified consultants with relevant expertise.
What Pharma Manufacturers Must Do to Comply:
Establish a robust Quality Management System:
Implement documented procedures for all critical operations.
Ensure proper training and qualification of all personnel.
Conduct regular internal audits and product quality reviews.
Investigate and address all deviations and non-conformances promptly.
Maintain Clean and Controlled Production Environments:
Implement stringent hygiene and sanitation practices.
Ensure proper maintenance and calibration of equipment.
Control environmental factors that could impact product quality.
Comply with Personnel Requirements:
Ensure adequate training and supervision of all personnel.
Implement appropriate personnel hygiene measures.
Restrict activities that could contaminate APIs.
Stay Updated on Regulatory Changes:
Regularly review and update procedures to align with the latest revisions to Schedule-M.
Stay informed about evolving regulatory expectations and industry best practices.
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.
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Next: Key Notes on Revised Schedule M: API Part-2 ….coming soon
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