InstantGMP Compliance Seriesfor cGMP Dietary Supplements

Complaints and Recalls

Electronic cGMP Manufacturing Execution System

Complaints and Recalls

• Identifying key issues in product complaints is a tool for quality improvement

• Primary Principle:

Complaints and information concerning potentially defective products must be carefully reviewed and corrective action taken

Electronic cGMP Manufacturing Execution System

Procedure

• Written procedure (SOP):– Describes action to be taken– Includes need to consider a recall (e.g. possible

product defect) • Designated responsible person:

– To handle complaint– Decide on measure to be taken– Has sufficient support staff– Has access to records

Electronic cGMP Manufacturing Execution System

Investigation

• Thorough investigation:– QC involved– With special attention to establish whether

"counterfeiting" may have been the cause– Fully recorded investigation – reflect all the details

• Depending on product defect (discovered or suspected)– Consider checking other batches– Consider batches containing reprocessed product

Electronic cGMP Manufacturing Execution System

Distribution Records

• Available to authorized person and contain sufficient information on:– Wholesalers– Direct customers– Export locations– Batch numbers and quantities– Including for clinical tests and medical samples

• Permit effective recalls

Electronic cGMP Manufacturing Execution System

Follow Up

• Investigation and evaluation should result in appropriate follow-up actions– May include a "recall"

• All decisions and measures taken should be recorded

• Referenced in batch records• Records reviewed - trends and recurring

problems

Electronic cGMP Manufacturing Execution System

Classification of Defects

• If complaint is justified, then there has been a failure of the quality system

• Once defect has been identified, company should be dealing with it in an appropriate way, even recall

• The definition of defects is useful, e.g.– Critical defects– Major defects– Other defects

Electronic cGMP Manufacturing Execution System

Critical Defects

• Those defects which can be life-threatening and require the company to take immediate action

• Examples– Product labelled with incorrect name or incorrect

strength – Counterfeit or deliberately tampered-with product– Microbiological contamination of a sterile product

Electronic cGMP Manufacturing Execution System

Major Defects

• Defects which may put the consumerat some risk but are not life-threatening and will require the batch recall or product withdrawal within a few days

• Examples– Any labelling/leaflet misinformation (or lack of

information) which represents a significant hazard to the patient

– Microbial contamination of non-sterile products with some risk for patients

– Non-compliance to specifications

Electronic cGMP Manufacturing Execution System

Other Defects

• Those defects which present only a minor risk to the consumer— batch recall or product withdrawal would normally be initiated within a few days

• Examples– Readily visible isolated packaging/closure faults– Contamination which may cause spoilage or dirt and

where there is minimal risk to the patient

Electronic cGMP Manufacturing Execution System

Reasons for Recall

• Customer complaint

• Detection of GMP failure after release

• Request by the national authorities

• Result of an inspection

• Known counterfeiting or tampering

• Adverse reaction reporting

Electronic cGMP Manufacturing Execution System

Summary

• Complaints may lead to defective product• Manufacturers are responsible for assuring the

consumers at not at risk • Critical defects can be life-threatening and

require immediate action• Major defects may put the consumer at some

risk, but are not life-threatening• Recalls must be handled positively and carefully

reviewed to be effective

InstantGMP™

Find more presentations on cGMP Compliance for Dietary

Supplements in the Resource Center at

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