Basic Principles of Complaint Handling and Managing the Complaint Handling Process

Basic Principles of Complaint Handling

The authors of Good Manufacturing Practice (GMP) for drug products realized that consumer feedback, when properly captured and used, can lead to product improvements. In addition, complaints on drug products can also help identify problems with the product that may not have been anticipated during the drug development or clinical trial stage. This instructional guide will provide an introduction to proper and effective handling of drug complaints.

Elements of GMP Requirements and FDA Expectations

➢Written Procedures

➢Deficiencies in Complaint Handling procedures by FDA Investigators

➢Failure to Capture all Complaints

➢Failure to Include Timelines

➢Failure to Expand the Investigation

➢Documentation

➢Deficiencies noted in Documentation by FDA Investigators

➢Complaint Details

➢Investigation Details

➢Close-out Details

➢Investigation

➢FDA Expectations

➢Assessment of Impact

➢Types of Complaints

➢Critical or serious

➢Major

➢Minor

➢Corrective And Preventative Action (CAPA)

➢CAPA “rules” (chart)

➢Trend Analysis

➢Adverse Trends

Includes Industry Definitions and References

Managing the Complaint Handling Process: A Compliance Narrative from a Fictional Company

This compliance narrative-an ongoing conversation between one manager and one former employee who rejoins the company-illustrates how one fictional company manages their complaint handling process.

Ideal for personnel training, this compliance narrative provides information on how many of the issues presented in “Basic Principles of Complaint Handling” Instructional Guide are applied.

This compliance narrative discusses the following topics, including:

➢Receiving and documenting customer complaints

➢Medical and safety assessment of complaints

➢Quality assurance assessment of complaints

➢Root cause investigations

➢CAPA identification and management

➢Trend analysis

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