Last Updated on December 21, 2024 by The Health Master

Complaints and Adverse reaction

Key considerations for Point No. 6 – Complaints and Adverse reaction compliance under revised Schedule M are outlined below.

Continued from: Key Notes on Revised Schedule M: Point No. 5 – Qualification and validation

Key Notes on Revised Schedule M: Point No. 6 – Complaints and Adverse reaction

Compliance for Complaints and Adverse Reactions

To comply with Good Manufacturing Practices (GMP) for pharmaceutical products, manufacturers must adhere to the following principles regarding complaints and adverse reactions:

Comprehensive Review and Action:

• All complaints and information about potential product defects must be thoroughly reviewed according to established procedures.
• Corrective actions must be implemented promptly.

Designated Responsibility:

• A specific person must be assigned to handle complaints and make decisions on necessary actions.
• Sufficient support staff should be provided to assist this person.
• The authorized person must be informed of any complaint, investigation, or recall.

Written Procedures:

• Clear written procedures must outline the steps to be taken in response to a complaint, including consideration of a product recall.

Product Defect Investigation:

• Special attention must be given to determining if the product that caused the complaint was indeed defective.
• All complaints about product defects must be recorded in detail and thoroughly investigated.
• The Quality Control (QC) department should be involved in reviewing these investigations.

Batch Evaluation:

• If a product defect is identified or suspected in a batch, other batches, especially those containing reprocessed material from the defective batch, must be evaluated to determine if they are also affected.

Follow-up Action:

• Necessary follow-up actions, including product recalls, must be taken after investigating and evaluating complaints.

Record Keeping:

• All decisions made and actions taken in response to complaints must be documented and linked to the corresponding batch records.
• Complaint records must be regularly reviewed to identify any recurring or specific problems that may require further action, such as product recalls.

Regulatory Notification:

• Licensing authorities must be informed if the manufacturer is considering action due to faulty manufacturing, product deterioration, suspected product issues, or other serious quality problems.

Pharmacovigilance System:

• A robust pharmacovigilance system must be in place to collect, process, and report adverse drug reactions to the licensing authorities.

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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: Point No. 7 –Product recalls

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