Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on May 20, 2025 by The Health Master
API Part-4
Key notes for API Part-4 for compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: API Part-3
Good Manufacturing Practices for API Part-4
Manufacturing API Part-4: 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-4
Schedule M Part XII: manufacturing and Control of Active Pharmaceutical Ingredients (APIs)
Key Points:
Raw Material Handling:
Accurate weighing and measuring of raw materials are very important.
Proper identification and storage of sub-divided materials are important.
Proper weighing and measuring processes require witnessing or equivalent controls.
Production processes:
Verification and identification of materials used in the batch are mandatory.
Critical production activities necessitate witnessing or equivalent controls.
Monitoring and investigation of yield deviations are essential.
All deviations must be documented and investigated.
Clear indication of the processing status of equipment is required.
Robust controls are necessary for reprocessed or reworked materials.
Time Limits:
Adherence to time limits specified in the master production instructions is crucial.
Appropriate storage conditions for intermediates are essential.
In-process Sampling and Control:
Written procedures for in-process monitoring and control are mandatory.
In-process controls are tailored based on the nature of the API and process steps.
Critical in-process controls require written procedures and approval from quality units.
Qualified personnel can perform certain in-process adjustments within pre-established limits.
Scientifically sound sampling methods and procedures are required.
Sampling procedures must prevent contamination of materials.
Out-of-specification investigations are generally not required for routine in-process monitoring.
Blending Batches:
Clear definition and control of blending operations are essential.
OOS batches cannot be blended with other batches.
Acceptable blending operations include blending small batches and tailings.
Blending processes require adequate control and documentation.
Traceability of batches within a blend is crucial.
Validation of blending processes is necessary to ensure homogeneity.
Stability testing of blended batches may be required.
The expiry/retest date of the blended batch is based on the oldest component.
Contamination Control:
Adequate control measures are necessary to prevent cross-contamination between batches.
Production operations must prevent contamination of APIs by other materials.
Precautions are essential to avoid contamination of APIs after purification.
Packaging and Labeling:
Written procedures for handling packaging and labeling materials are required.
Packaging materials must conform to established specifications.
Records of packaging and labeling material handling must be maintained.
Containers must provide adequate protection for the API.
Clean and suitable containers are essential.
Reused containers must be thoroughly cleaned.
Controlled access to label storage areas is crucial.
Reconciliation of label issuance, usage, and return is mandatory.
Obsolete and outdated labels must be destroyed.
Printing devices for labels must be controlled.
Printed labels must be carefully examined and documented.
A representative printed label must be included in the batch production record.
Documented procedures to ensure correct packaging materials and labels are essential.
Labeling operations must be designed to prevent mix-ups.
Labels must include essential information such as product name, batch number, storage conditions, and manufacturer details.
Packaging and labeling facilities must be inspected before use.
Examination of packaged and labeled APIs to ensure correct labels is mandatory.
Containers for transport outside the manufacturer’s control must be adequately sealed.
Compiled by:
Rakesh Dahiya, Asstt. State Drugs Controller, FDA Haryana
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