Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Key Notes on Revised Schedule M: Point No. 8 – Change Control - December 15, 2024
- Forms: All types for Hospital RMI - December 14, 2024
- Key Notes on Revised Schedule M: Point No. 7 – Product Recall - December 14, 2024
Last Updated on December 16, 2024 by The Health Master
Product recall
Key considerations for Point No. 7 – Product Recall compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Point No. 6 – Complaints and Adverse reaction
Pharma Manufacturer’s Obligations for Product Recall
To comply with Good Manufacturing Practices (GMP) for Pharmaceutical Products, manufacturers must adhere to the following product recall principles:
Establish a Recall System: Implement a system to identify and recall products that are defective or suspected of being defective.
Designate a Responsible Person: Assign an authorized person to oversee and coordinate all aspects of product recall.
Develop Written Procedures: Create detailed, regularly reviewed, and updated written procedures for organizing and executing recall activities.
Must read: CDSCO Guidelines on Drug Recall
Secure Recalled Products: Store recalled products in a secure, segregated area.
Inform Regulatory Authorities: Notify the licensing authorities of any intended product recall.
Maintain Distribution Records: Keep accurate and easily accessible distribution records to facilitate effective recalls.
Monitor and Record Recall Progress: Track the progress of recall activities and document the disposition of recalled products.
Evaluate Recall Effectiveness: Regularly assess the effectiveness of the recall system and make necessary improvements.
Implement a Timely Recall System: Develop a prompt and efficient recall system to inform all relevant parties, including stockists, wholesalers, suppliers, and retailers.
Utilize Multiple Communication Channels: Employ both print and electronic media to disseminate recall information.
Standardize Recall Procedures: Establish standard operating procedures (SOPs) for effective product recalls.
Ensure Record Availability: Make distribution records readily accessible to designated recall personnel.
Document Recall Outcomes: Prepare a final report detailing the reconciliation of delivered and recovered product quantities.
Secure Recalled Products: Store recalled products separately in a secure, segregated area until a final decision is made.
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Next: Key Notes on Revised Schedule M: Point No. 8 – Change Control ….coming soon
Key Notes on Revised Schedule M: Must read
Important short notes for Industry and Regulators
CDSCO Guidelines on Drug Recall
Quality Assurance Vs Quality Control in the Pharma Industry
Major FDA audit findings about Equipment and Instruments
Understanding GMP, cGMP, and WHO-GMP
Quality Assurance in the Pharmaceutical Industry
Duties and responsibilities of QA person in Pharma Industry
Difference: Disintegration and Dissolution test in pharma industry
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
Licensing procedure for manufacturing of Drugs
Procedure to obtain license for manufacturing of Cosmetics
Procedure to obtain license for manufacturing of Homoeopathic Medicines
Procedure to obtain license for manufacturing of Medical Devices
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
Procedure to obtain license for Blood Centre (Blood Bank)
Procedure to obtain license for Commercial Testing Laboratories
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