Skip to content
  • Pharma SOP
  • Pharma GMP
  • Pharma Stability Study
  • Pharma Tips
  • Pharma Books

Schedule M Compliance

Your Guide to Achieving GMP Excellence

  • Home
  • What is New!
  • How-To-Implement
  • GMP
  • Regulatory
  • QA & QC
  • Toggle search form

Product Recall Records

Posted on May 1, 2024May 1, 2024 By digi No Comments on Product Recall Records

Recall Records

Recall records are documents that capture information related to the recall of products from the market due to safety concerns, quality issues, or regulatory non-compliance. These records document the entire recall process, including initiation, communication, retrieval, and resolution of recalled products.

Key Components of Recall Records:

  • Reason for Recall: Explanation of the reason for initiating the product recall, such as contamination, labeling errors, or safety concerns.
  • Recall Plan: Detailed plan outlining the steps to be taken during the recall process, including communication strategies and retrieval procedures.
  • Communication Logs: Records of all communications related to the recall, including notifications to regulatory authorities, distributors, and consumers.
  • Product Disposition: Documentation of how the recalled products were handled, whether they were destroyed, reworked, or returned to the manufacturer.
  • Effectiveness Evaluation: Assessment of the effectiveness of the recall process, including verification of product retrieval and resolution of the issue.

Purpose of Recall Records:

Recall records play a crucial role in ensuring swift and effective management of product recalls to protect public health and safety. These records help companies track and document recall activities, assess the impact of the recall, and prevent similar issues in the future.
Accurate and comprehensive recall records are essential for demonstrating regulatory compliance, transparency, and accountability in handling

product recalls. By maintaining detailed recall records, organizations can mitigate risks, protect their reputation, and prioritize consumer safety in the event of product recalls.

Template For ‘Recall Record’

Product Details

  • Product Name: [Product Name]
  • Batch Number: [Batch Number]
  • Reason for Recall: [Reason for Recall]
  • Date of Recall: [Date of Recall]

Recall Process

Describe the steps taken during the recall process, including initiation, communication, retrieval, and disposal of recalled products.

Communication Plan

Outline the communication plan for notifying relevant parties about the recall, including regulatory authorities, distributors, and consumers.

Investigation and Evaluation

Summarize the investigation conducted to determine the root cause of the recall and evaluate the effectiveness of the recall process.

Corrective Actions

Detail any corrective actions implemented to prevent similar recalls in the future, including process improvements and quality control measures.

Conclusion

The Recall Records document the details of product recalls, including reasons, actions taken, and outcomes of the recall process. It serves as a record of quality assurance and compliance with recall procedures.

Documentation Tags:CDSCO Schedule M compliance, GMP training India, Good Manufacturing Practices India, India pharma GMP, India pharma regulations, New Schedule M, Pharma GMP certification India, Pharma GMP standards in India, Pharmaceutical manufacturing in India, Pharmaceutical quality assurance, Schedule M compliance, Schedule M documentation, Schedule M guidelines, Schedule M infrastructure requirements, Schedule M personnel requirements, Schedule M premises layout, Schedule M quality control, Schedule M record keeping, Schedule M regulations, Schedule M storage and distribution, Schedule M validation and qualification

Post navigation

Next Post: Product Distribution Records

Leave a Reply

Your email address will not be published. Required fields are marked *

Copyright © 2024 Schedule M Compliance.

Powered by PressBook WordPress theme