Handling of Customer Complaint-GMP- by Dr. A. Amsavel

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Handling of customers complaint

• Dr. A. Amsavel

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Overview

• Reference Guideline
• Definitions
• GMP Requirement 21 CFR 211.198 and ICH Q7
• Procedure for Handling of Complaints
• Complaint Investigation
• Remedial action and CAPA
• Report preparation
• Response to customer
• Verification of CAPA effectiveness
• Review of Complaints

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Guidelines/ requirements

• 21 CFR 211.198 Complaint files.
• Investigation according to 21 CFR 211.192
  Production record review Record and Reports
  shall be available 211.180(c).
• Field Alert Report Submission Questions and
  Answers Guidance for Industry July 2018
• ICHQ7 GMP for API Section -15 Complaints and
  Recalls

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Definition

• Correction An action to eliminate a detected
  nonconformity. ie Remedial action, Reprocess,
  rework, or adjustment
• Corrective Action The action taken to eliminate
  the causes of an existing nonconformity, defect
  or other undesirable situation in order to
  prevent recurrence.
• Preventive Action The action taken to eliminate
  the cause of a potential nonconformity, defect,
  or other undesirable situation in order to
  prevent occurrence.

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Definition

• Conforming Fulfillment of a requirement. An
  expected observation, event or characteristic.
• Nonconforming Material or Process (Discrepancy)
  Any material or process that does not meet its
  required specifications or documented procedure.
• Nonconformity Non-fulfillment of a specified
  requirement. (Any material or process that does
  not meet its required specifications or
  documented procedure).
• Complaint Customer / consumer reporting on the
  product or service, due to non-confirming of
  product or process or service. It may be related
  to quality, packing, document, service, etc.

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Definition

• Field Alert Report (USFDA)
• Any incident that causes the drug product or its
  labeling to be mistaken for or applied to another
  article, bacterial contamination, a significant
  chemical, physical, or other change,
  deterioration in the distributed drug product,
  and failure of one or more distributed batches of
  the drug product to meet the specifications
  established in its application
• I

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Purpose of Complaint Handling

• To ensure the patient safety.
• To meet Regulatory Requirement
• To maintain cGMP
• To maintain relationship with customers
• It is reputation of company
• It is an opportunity to improve the quality of
  the product or service
• To improve the business growth

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21CFR 211.198 Complaint Files

• Procedures shall be established and followed for
  handling of all written and oral complaints
  regarding a drug product
• Any complaint involving the possible failure of a
  drug product to meet any of its specifications
  need for an investigation in accordance with
  211.192.
• Review to determine whether the complaint
  represents a serious and unexpected adverse drug
  experience which is required to be reported to
  the Food and Drug Administration

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21CFR 211.198- Complaint files.

• A written record of each complaint shall be
  maintained at the site and readily available for
  inspection
• Written records related to complaint shall be
  maintained until at least 1 year after the
  expiration date of the drug product, or 1 year
  after the date that the complaint was received,
  whichever is longer.
• For OTC drug products records shall be maintained
  for 3 years after distribution of the drug
  product.

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21CFR 211.198- Complaint Files

• Record shall include the following information,
  the name and strength of the drug product, lot
  number, name of complainant, nature of complaint,
  and reply to complainant.
• Record of Investigation conducted, and findings
  and follow-up.
• The record of the investigation shall be
  maintained
• If investigation is not conducted, record the
  reason for an investigation was not necessary and
  the name of the responsible person making such a
  determination.

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ICH Q7 15.0 Complaints and Recalls

• All quality related complaints, whether received
  orally or in writing, should be recorded and
  investigated
• Complaint records should include
• Firm, Name, title , phone number, address of the
  complaintant
• Date complaint is received
• Complaint nature (Product batch number of the
  API)
• Immediate Action taken if any (dates action
  taken by the person)
• Investigation CAPA
• Response provided to the originator of complaint
  with date
• Final decision / Conclusion
• Follow-up action taken

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ICH Q7 15.0 Complaints and Recalls

• Records of complaints should be retained in order
  to evaluate trends, product related frequencies,
  and severity with a view to taking additional,
  and if appropriate, immediate corrective action.
• There should be a written procedure that defines
  the circumstances under which a recall of an
  intermediate or API should be considered.
• The recall procedure should designate who should
  be involved in evaluating the information, how a
  recall should be initiated, who should be
  informed about the recall, and how the recalled
  material should be treated.
• In the event of a serious or potentially
  life-threatening situation, local, national,
  and/or international authorities should be
  informed and their advice sought.

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Procedure for Handling of Complaints

• SOP for investigation and reporting the market
  complaints should cover the following, but not
  limited to
• Purpose, Scope, Responsibility Authority
• Cover all quality-related or other complaints,
  whether received orally or in writing, is being
  recorded and investigated
• Record the receipt of the complaint in complaint
  log book
• Acknowledge the receipt of complaint (timeline eg
  within 24hrs)
• Classify on nature of complaint. eg. Product
  quality , Packaging, Document, Label etc
• Categorize as Critical / Major / Minor

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Procedure for Handling of Complaints

• Containment of complaint batch , if required
• Investigation of complaint based on the complaint
  nature. Testing of reserve sample, review of
  manufacturing and test records, Equipment,
  calibration, facility, environment etc ..
• Time period for investigation
• Content of Investigation report and response to
  customer
• If complaint is not genuine or send response with
  justification
• Remedial action and CAPA as appropriate
• Closing of complaint
• Review of effectiveness
• Maintain the compliant records

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Complaint investigation

• Record the receipt of the complaint in complaint
  log book
• Complaint number Date of complaint received
• Details of organisation/person, title, address,
  contact of complainant
• Product name, Batch number, quantity and date of
  supply
• Nature of Complaint Quality , packing,
  document error, label etc
• Category - Critical/ Major/ Minor
• Containment of material, if stock is available
  from the complaint batch at warehouse.
• Time period for investigation and response to
  customer
• If it is critical (life threaten) send response
  within 2-5 days to contain / action at customer
  end, and investigation can be continued
• Other than critical 2-4 weeks
• Interim report if investigation required time

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Investigation Steps

• Define the Complaint
• Evaluate the Magnitude and Impact
• Make a Plan for Investigation
• Identify RCA thorough Assessment
• Remedial CAPA plan with tasks
• Implementation the action plan
• Follow up /verify the effectiveness
• Use investigation tool as required ie. why-why,
  cause and effect (fish bone), brainstorm, FEMA
  etc

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Complaint Investigation

• Investigation Uses check list for review /
  verification
• Test the reserve sample of the complaint batch.
  If required test the previous and subsequent to
  complaint batches.
• Request sample from customer if required for
  investigation and test the sample
• Form the Investigation team QA, QC, production
  and if required ES, RD and others
• Review the records (details -next slide)
• Identify the root cause or probable cause
• If required visit the customer site for
  investigation

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Investigation Review of records

• Review past history /similar issue their
  investigation reports
• Review the following records and documents, but
  not limited to
• BPR, cleaning record, test records, trend ,
  change control ...
• OOS, deviation if found
• Review of input material, quality, quantity
  vendor
• Review process/operations
• Review the situation/ environment
• Review of Systems / facility/ Equipment
• Eg. Environment, Log book, cleaning,, PM,
  Calibration physical check etc
• Interview people involved in the manufacturing,
  sampling testing
• Gemba-Inspect equipment facilities at site
• Any additional testing required based on the
  above

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Complaint Investigation

• Review the storage transportation, if special
  storage condition recommended
• Extend the investigation to other batches ,
  other campaign, other Product / materials,
  other Equipment / train etc
• Evaluate Product Impact / Disposition
• Provide reason for accept / rejection of the
  batch based on the outcome of the investigation.
• Justify the exclusion of other batch if required
• Consider toxicological evaluation if required
• Remedial Action/Correction Action to address an
  immediate problem ie Reprocess/ reworking or can
  be taken in conjunction with CAPA

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Complaint Investigation Report

• Prepare the Complaint Investigation report with
  the following details, but not limited to,
• Complaint number Date of complaint received
• Details of organisation/person, title, address,
  contact of complainant
• Product name, Batch number, quantity and date of
  supply
• Nature of Complaint Quality , packing,
  document error, label etc
• Category - Critical/ Major/ Minor
• Immediate action taken (with date name of
  person taking the action)
• Investigation report with root cause or most
  probable cause
• Remedial action or correction
• Corrective action and preventive action if
  possible
• Conclusion Recommendation to customer if
  required
• Decision on recall, if complaint is serious or
  potentially life-threatening situation.

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Response to Customer

• Information to regulatory agencies if complaint
  is serious or potentially life-threatening
  situation.
• Submit the investigation report to customer as
  per time line specified in the SOP and based on
  the nature of complaint.
• In case the investigation require additional
  time, provide interim report and get extended
  time with justification.
• The complaint shall be closed based on the
  acceptance of the response from the customer and
  assessment of CAPA.
• In case the customer is not responding within 2-3
  weeks send the reminder for feedback if customer
  is not responding, inform as complaint is closed.

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Complaint Verification Records

• Verify the implementation of correction and CAPA
  for its effectiveness.
• Review the complaint periodically (may be monthly
  or quarterly) to determine if there are any
  unfavourable trends in the complaint data.
• Review all the complaints in the management
  review meeting
• All complaints shall be reviewed and reported in
  APQR
• Complaint records shall be maintained at least
  one year after retest date of API or expiration
  date of drug product

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Recall

• Decision on recall, if complaint is serious or
  potentially life-threatening situation.
• Information to local, national, and/or
  international authorities should be informed and
  their advice sought.
• Initiate the recall as per procedure should
  designate who should be involved in evaluating
  the information,
• Who should be informed about the recall, and
• How the recalled material should be treated.

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• Thank You
• Dr. A. Amsavel