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
www.instantgmp.com