Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on August 15, 2025 by The Health Master
API Part-7
Key notes for API Part-7 for compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: API Part-6
Good Manufacturing Practices for API Part-7
Manufacturing API Part-7: 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-7
Schedule M Part XII: manufacturing and Control of Active Pharmaceutical Ingredients (APIs)
Key Points:
• Materials Rejection and Reuse:
o Identify and quarantine intermediates or APIs that are not meeting the specifications.
o Reprocessing: Acceptable if it involves important steps like crystallization, distillation, or filtration. However, if used frequently, it must be part of the standard process.
o Investigation: Investigate the reason for non-conformance before reprocessing. Ensure reprocessed batches meet quality standards through appropriate testing and validation.
o Material Recovery: Recover reactants, intermediates, or APIs from mother liquor or filtrates if approved procedures exist and recovered materials meet the required specifications.
o Solvent Recovery: Recover and reuse solvents if recovery procedures are controlled and monitored. Fresh and recovered solvents can be combined with adequate testing.
o Returns: Quarantine returned materials. Reprocess, rework, or destroy them if their quality is questionable. Maintain detailed records of returned materials.
• Complaints and Recalls:
o Investigate all quality-related complaints and maintain the records.
o Maintain detailed complaint records including complainant information, nature of the complaint, and actions taken.
o Establish a written procedure for recalling the APIs, outlining the recall process, communication channels, and treatment of recalled materials.
o Inform licensing authorities about all the recalled products.
• Contract Manufacturers:
o Ensure compliance with GMP for all contract manufacturers, including laboratories.
o Evaluate contract manufacturers to ensure GMP compliance at their facilities.
o Establish written contracts defining GMP responsibilities for both the contract giver and acceptor.
o Allow for audits of contract manufacturers by the contract giver.
o Obtain prior approval for any sub-contracting arrangements.
o Maintain manufacturing and laboratory records at the site where the activity takes place.
o Obtain approval for any changes in the process, equipment, test methods, or specifications.
• Fermentation Processes:
o Classical Fermentation: Employs traditional microorganisms for producing low-molecular-weight APIs like antibiotics, vitamins, and amino acids.
o Biotechnological Processes: Utilize genetically modified organisms to produce APIs, primarily high-molecular-weight substances like proteins and polypeptides.
• Key points for cell culture & fermentation:
o Strict Controls: Maintain strict controls throughout the manufacturing process, starting from cell banking and encompassing all stages of cultivation, harvest, and purification.
o Minimizing Contamination Risk: Implement measures to prevent microbial, viral, and endotoxin contamination, such as using closed equipment and systems, maintaining aseptic conditions, and employing appropriate environmental controls.
o Critical Process Monitoring: Continuously monitor critical parameters like temperature, pH, and agitation rates to ensure consistent and high-quality API production.
o Effective Purification: Employ efficient purification techniques to remove impurities, including host cell proteins, media components, and contaminants, while preserving API quality.
• Cell Bank Management:
o Secure Storage: Maintain cell banks under controlled conditions to ensure viability and prevent contamination.
o Limited Access: Restrict access to authorized personnel only.
o Regular Monitoring: Regularly assess cell bank suitability for use.
• Manufacturing APIs for Clinical Trials:
o Flexibility and Adaptability: Adapt manufacturing processes based on the stage of clinical development, allowing for changes as knowledge and understanding of the API evolve.
o Focus on Quality: Emphasize strict quality control measures, including raw material testing, batch release approval, and evaluation of process deviations.
o Controlled Environments: Ensure suitable facilities and equipment to minimize contamination and cross-contamination risks.
• Compliance for Pharma Manufacturers:
o Adhere to GMP Principles: Implement Good Manufacturing Practices (GMP) throughout all stages of API production, including those for clinical trials.
o Establish Quality Units: Create independent quality units to oversee batch release and ensure product quality.
o Documentation: Maintain detailed records of all production and control activities, including deviations and investigations.
o Process Validation: Conduct thorough process validation for commercial API production, ensuring consistent and reproducible results.
o Change Management: Establish a robust system for managing and documenting all changes to the manufacturing process, specifications, or testing procedures.
Note:This article aims to provide a general overview of Schedule M Part XII. It is essential to consult the official guidelines and seek expert advice for specific interpretations and implementation.
Compiled by:
Rakesh Dahiya, Asstt. State Drugs Controller, FDA Haryana
Next: Key Notes on Requirement of Plant and equipment ….coming soon
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