Regulatory Compliance for Product Reviews, Complaints & Recalls, Study notes of Pharmacology

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Product Complaints, Recalls andProduct Complaints, Recalls and

Annual Product Reviews Annual Product Reviews

NCCU, BRITE

Instructor: Tom Walton October 21 / 28, 2010

Lecture OutlineLecture Outline

 (^) Product Complaints  (^) Regulatory Reference  (^) Receipt  (^) Investigation  (^) CAPA  (^) Complainant Response  (^) Trending and Reporting  (^) Recall  (^) Regulatory Reference  (^) Process  (^) Annual Product Review  (^) Regulatory Reference  (^) Purpose  (^) Typical Content

Product Quality ComplaintsProduct Quality Complaints Regulatory Reference Regulatory Reference  (^) CFR 21 Part 211.  (^) Orange Guide – Part 1 Chapter 8  (^) Procedures  (^) Investigate  (^) Document and Archive  (^) Trend and Report

ReceiptReceipt  (^) Methods of Receipt  (^) Letter  (^) Phone Call  (^) E-mail  (^) Regulatory Agency  (^) Verbal to Company Representative  (^) Key Information  (^) Complainant – Name, Address, Phone Number  (^) Drug Product – Package, Lot Number  (^) Complaint Details  (^) Product Return  (^) Tracking Number

CAPACAPA

 (^) Potential CAPA  (^) Facility / Equipment Changes  (^) Procedure Changes  (^) Training  (^) Product Recall  (^) No CAPA

Complainant ResponseComplainant Response  (^) Communication (Letter)  (^) Appreciation for Report  (^) Acknowledgement of Concern  (^) High Level Note on Investigation  (^) Summary of Finding  (^) Company’s Commitment to Quality

RecallRecall

Regulatory Reference Regulatory Reference

 (^) CFR 21 Part 7.4, 7.5 & 314.  (^) Orange Guide – Part 1 Chapter 8  (^) Procedures  (^) Prompt Notification and Action  (^) Classification and Depth  (^) Identification and Segregation  (^) Effectiveness Checks  (^) Report and Destroy

Recall ProcessRecall Process

 (^) What is a recall?  (^) Removing of product from the market that is in violation of the laws administered by the FDA  (^) Voluntary action by firms to carry out obligation to protect public health  (^) Alternative to court ordered seizure  (^) Identification of Issue  (^) Complaint  (^) Internal Investigation  (^) Stability Result  (^) Adverse Events  (^) Product Tampering  (^) Health Hazard Evaluation

Recall ProcessRecall Process

 (^) Recall Depth / Considerations  (^) Consumers  (^) Pharmacies  (^) Wholesalers  (^) Notification  (^) Recall notification to distribution level  (^) Public Warning  (^) Recall Effectiveness  (^) Status Reports and Termination

Annual Product ReviewAnnual Product Review

Regulatory Reference Regulatory Reference  (^) CFR 21 Part 211.180 (e)  (^) Orange Guide – Part 1 Chapter 1  (^) Procedures  (^) Review batch data  (^) Review complaints, recalls  (^) Review of returned or salvaged product  (^) Review investigations  (^) Report and Act

ContentContent

 (^) Yield Data  (^) QC Data  (^) Production Volume  (^) Rejected Batches  (^) Complaint Quantity, Rate and Types  (^) Change Control Review  (^) Returned or Salvaged Drug Product Summary  (^) Recall Summary

ClosingClosing

Thanks for your Attention!! Any additional Questions?