instantgmp compliance series - complaints and recalls
DESCRIPTION
This presentation will address the GMP procedures for complaints and recalls.TRANSCRIPT
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™
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