Market complaints and product recall
DEFINITION:
- A ‘Complaint’ simply designates, that something is wrong or not good enough. Generally in the pharmaceutical industry, complaints are regarding the quality of drug products.
- A complaint shows customer dissatisfaction about a product and consequently, about a company.
- Principle: All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and corrective action should be taken.
- COMPLAINT HANDLING SYSTEM
- It gives the company an opportunity to improve the quality of the product.
- It is helpful to maintain cGMP.
- It maintains the committed relationship between the customer and the company.
- It is a regulatory obligation.
OBJECTIVE
- To immediately recall, investigate, or take remedial measures against the defective product.
RESPONSIBILITY
- The quality assurance manager along with the manager of the complaint-related department.
TYPES OF COMPLAINTS
Basically, it’s of three types: –
1) Quality complaints: Originate at the consumer level and concern with physical, chemical, and biological properties or condition of labeling and /or packaging of the product.
2) Adverse reaction complaints: Due to allergic reactions of any other untoward reaction or fatal reaction or near-fatal reaction.
3) Other medically related complaints: Include complaints such as lack of efficacy or clinical response.
The time period for investigation after receipt of complaints:
1. Product quality complaints – within 10 days.
2. Adverse reaction complaints– within 5 days.
3. Medical complaint – within 3 days.
Complaint records shall be maintained at least one year after the expiration date of medicines. Complaint records shall be reviewed and a monthly summary shall be prepared for the management.
Also, the complaints are categorized as follows
Critical defects
Major defects
Other defects
Critical Defects •
Those defects can be life-threatening and require the company to take immediate action by all reasonable means, whether in or out of business hours
Examples • Product labeled with an incorrect name or incorrect strength • Counterfeit or deliberately tampered-with product • Microbiological contamination of a sterile product.
Major Defects • Those defects which may put the patient at some risk but are not life-threatening and will require the batch recall or product withdrawal within a few days
Examples
• Any labeling/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 (e.g. active ingredient assay)
Other Defects
• Those defects which present only a minor risk to the patient — 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 25-09-2015 8
KEY POINTS FOR HANDLING COMPLAINTS
• Don’t take it personally
• Never act on a complaint without hearing (at least) two sides to the story
• Say what you will do and do what you say; set the time frame • Keep notes.
CONTENTS OF A PRODUCT COMPLAINT DATA SHEET
- Serial number assigned to the complaints
- Exact nature of the complaints
- Name of the complainants
- Address of the complainants
- Date of complaint received
- Name of the product, strength & batch number of the product
- The quantity involved in the complaint
- Size of the sample obtained from the complainant
- Evaluation of compliant by Q.C department
- Name and signature of the investigator & date
- The action was taken by the company
- Copy of reply sent to complainant
STEPS INVOLVED IN HANDLING OF COMPLAINTS
Step 1: Receiving Complaints It is important to have open channels with customers in order to receive their suggestions, doubts, and complaints.
Generally, these channels are toll-free numbers, e-mails, chat rooms, and P.O. boxes. Whatever the channel, it is necessary to have a person in charge of receiving the complaints and inputting them into an appropriate investigation form that shall be addressed to the Quality Assurance (QA) unit for investigation.
Step 2: Technical Investigation Upon receipt of the investigation form, the QA unit is able to start the investigation, which can be divided into two phases: documentation-based and laboratory analysis.
Documentation-based investigation – Consists of checking if this complaint occurred previously in the same lot or if any nonconformance was found in the lot during its production that could explain the complaint.
The primary documentation to be reviewed in this step consists of the complaint files and the batch records.
Laboratory analysis phase
– Consists of requesting the Quality Control (QC) laboratory to analyze both complaint samples and retained samples – the reserve samples representative of the lot manufactured.
If the customer did not send the complaint sample for analysis, the laboratory investigation will be carried out only with retained samples. Similar to the receiving step, it is fundamental that the company elects a person in the QA unit to be in charge of technical investigation of each complaint, e.g. a Complaint Officer.
After receiving the analytical results, there are three possible conclusions, as follows:
Confirmed complaint –
When both complaint and retained samples showed out-of-specification (OOS) results or when only the complaint sample showed OOS results, it is clearly a single unexplained failing product.
Non-confirmed complaint – When both complaint and retained samples showed results in compliance with specifications or when only the complaint sample showed OOS results that cannot be considered a single unexplained failing product. OOS results in a complaint sample can be attributed to misuse or mishandling.
Counterfeit/tamper suspicion
– When the retained sample is within the specification but the complaint sample is clearly OOS with no reason for that, such as a counterfeit or tampered drug product.
Step 3: Corrective Actions and Preventive Actions Corrective Action:
eliminate detected non-conformity. It aims to correct an existing non-conformity and to avoid reoccurrence of the same non-conformity.
Examples: arises from manufacturing deviations, OOS investigations, complaints, audit findings, recalls. Preventive Action: prevent nonconformity occurrence. It aims to avoid the initial occurrence of a non-conformity by proactively implementing improvements.
Examples: results from trending of in process data, of analytical data, of audit findings, trending of root causes for non-conformities or complaints, from product quality reviews (annual product reviews), quality risk analysis.
For all confirmed complaints, corrective actions must be implemented. These actions can range from simple and quick training to some employees to formal Corrective Action and Preventive Action (CAPA) handling. The criteria for choosing appropriate action depends on the nature of the complaint, and the complaint incidence. If a CAPA is opened, a multidisciplinary team consisting of representatives of QA, QC, Regulatory Affairs, and Production Management must be established.
Concerning non-confirmed complaints originating from misuse or inadequate handling of the drug product, even if there is no need for internal corrective actions, corrective measures should be implemented to provide orientation to the customer.
Regarding counterfeit or tampered suspicious complaints, a response letter should also be sent to the customer, but the Legal Affairs unit must be copied for further arrangements.
Step 4: Feed back to customers:
As feedback to the customer, the company must write a response letter to the complainant to explain the investigation approach taken, the results obtained and any implications, in case the quality problem was confirmed.
The customer should be sent a free replacement product together with the response letter since the customer returned the product (the ‘complaint sample’) to the company for analysis and a quality problem was found.
Step 5: Monthly Reports and Trend Analysis :
Monthly reports should be elaborated in order to evaluate the amount and the nature of the complaints received and to perform a trend analysis of these complaints.
RECORDING OF COMPLAINTS :
It is the responsibility of the in-charge, Quality control to see that each complaint is recorded, evaluated, and reported to the management.
Records of complaints should include the following information:-
1. Contents of complaints – These should include: –
Name, dosage form, package form, batch no.
Date and the place of occurrence of complaint
Cause of complaint
Name and address of complaint in detail.
2. Results of investigation – These should include: –
Regarding marketplace, circulation condition and condition in which the defect was observed
Results of investigation of analysis and testing records, production and storage records
3. Evaluation
4. Follow-up measures – It includes:-
Reply to the complainant
Remedial action so that complaints of this type should not reoccur.
PRODUCT RECALL :
PRODUCT RECALL
DEFINITION:
A process for withdrawing or removing a pharmaceutical product from the pharmaceutical distribution chain because of defects in the product, complaints of serious adverse reactions to the product, and/ or concerns that the product is or may be counterfeit. The recall might be initiated by the manufacturer, wholesale dealer license holder, or the Department of Health.
PRINCIPLE: “There should be a system to recall from the market promptly and effectively, products known or suspected to be defective.”
Reasons for Recall:
- Customer complaint
- Detection of GMP failure after release
- The result from the ongoing stability testing
- Request by the national authorities
- Result of an inspection
- Known counterfeiting or tampering
- Adverse reaction reporting
OBJECTIVES:
- To stop the distribution and sale of the affected product.
- Effectively notify Management, customers, and regulatory authority.
- Efficiently remove the affected product from the marketplace, warehouse, and/or distribution areas.
- Dispose and Conduct a root cause analysis and report the effectiveness and outcome of the recall.
- Implement a corrective action plan to prevent another recall.
RESPONSIBILITY:
• General manager president: QA/QC Regulatory
• General Manager: manufacturing.
• Regulatory GM Manufacturing GM.
RECALL CLASSIFICATION FDA classified the product recall depending on the health hazard caused by the product in the following way:
Class I Recall–
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
EX: Correct product but wrong strength, Microbial contamination of sterile injection or ophthalmic product, Wrong active ingredient in a multi-component product with serious medical consequences.
Class II Recall-
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences
EX: Mislabeling, wrong or missing text or figures, Missing or incorrect information- leaflets or insert.
Class III Recall-
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. EX: Faulty packaging, wrong or missing batch number or expiry date, Faulty closure, Contamination- microbial spoilage, dirt or detritus, particulate matter.
RECALL STRATEGY:
A planned specific course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for recall.
DEPTH OF RECALL:
Depending on the product’s degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, i.e., wholesaler, retailer, user/consumer. 25-09-2015 27
RECALL NUMBER: Number assigned for each recalled product by a responsible center. This number consists first of a letter designating the responsible center (letter codes), a 3-digit sequential number indicating the number of recalls. Initiated by that center during the fiscal year, and a 1-digit number indicating the fiscal year the recall was initiated. For e.g., F-010-21 identifies the 10th recall initiated by the Centre for Food Safety and Applied Nutrition in FY-2021.
RECALL TEAM:
The Team is responsible for coordinating all aspects of the product recall. A recall coordinator is to be appointed and members of a recall team identified from the various functional areas.
Together the team will assist the Recall Coordinator in the event of the recall. The Recall Management Team list shall be updated at least four times a year to ensure all names, contact phone numbers, and responsibilities of team members and alternates are updated.
LIST OF FORMS REQUIRED FOR RECALL:
Notification of Withdrawal
Notification of Recall
Recall Log
Problem Report
QA Incident Hold Form
Receiving Log
Shipping Log
Recipe(s)
Process Flow of Statutory recall Initiated by DDA
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Received by Manufacturer/Authorized Importer
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Communication to Distributors/Wholesalers / Retailers (as applicable)
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Distributor / Wholesalers calls back the distributed quantity of product/batch
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Receipt, labeling & storage of recalled stock
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Investigation of Product / Batch by QA
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Root Cause Identification, CAPA & Documentation
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Communication of Investigation findings
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Reconciliation & Disposition of recalled batch (if any)
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Closure of recall
VOLUNTARY RECALL BY MANUFACTURERS :
Identification of a potential non-compliance Issue
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Communication to QA
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QA to take a decision on recall as per the SOP of the manufacturing firm
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Inform DDA where product is marketed
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Recall log-in by QA
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Communication to Distributor / Wholesalers
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Distributor / Wholesalers calls back the distributed quantity of product/batch (es)
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Receipt, labeling & storage of recalled stock
↓
Investigation of Product / Batch by QA
↓
Root Cause Identification, CAPA & Documentation
↓
Communication of Investigation findings
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Reconciliation & Disposition of recalled batch (if any) Closure of recall
RECALL PROCEDURE RECALL NOTIFICATION/ INSPECTION
• Potentially violative product which may lead/ has lead to a class I or class II recall, an inspection should be made to determine the root cause(s) of the problem(s). If the firm has failed to take appropriate preventive action, violations should be documented for possible regulatory action.
INSPECTION PROCEDURES
• To identify the root cause for the recall and assure the firm has implemented procedures to prevent it from reoccurring.
• Verify the steps taken were sufficient in-depth and scope and reflect the correct conclusions about both the problem and correction.
• Determine if the firm conducted a failure analysis using techniques such as fault tree analysis or failure mode analyses, considering things such as the length of time the product has been manufactured and sold, complaints or returns for the same or similar problems, any reworking of the product prior to release or distribution which may have been due to the same or similar problems and, process or personnel changes which occurred about the time the problem appeared.
For all recall inspections in addition to verifying the identification of the root cause:
1. Issue a notice of inspection (FDA 482)
2. Discuss the suspected problem with management and review the firm’s complaint file.
3. Investigate all areas, control points, and/or circumstances that may have a bearing on the product’s deficiency.
4. Fully develop individual responsibility for the problem.
5. Review batch records, processing logs, and/or other types of records for violative lots and associated lots.
6. Review and obtain copies of the firm’s quality control/analytical data.
7. Determine any actions the firm has taken, is taking, or has planned to take to prevent similar occurrences. If corrective action is not underway, determine the firm’s timetable for achieving correction.
8. Determine what action the firm has taken or plans to take, and the time frames involved, regarding the questionable product(s) remaining in commerce.
RECALL DECISION FOLLOW–UP: If the firm has decided to recall, steps to be followed:
1. Management should obtain their FDA District’s review of recall correspondence and any press releases before they are issued to prevent misunderstandings between the firm, its customers, and the FDA.
2. Obtain an official sample of the recalled product.
3. Obtain a complete distribution list of all shipments of the suspect lot(s), including foreign distribution.
4. Obtain specimens or copies of all labels and labeling associated with the recalled product.
5. Obtain complete copies of all recall communications issued or planned including the text of phone conversations, and submit them to District’s recall coordinator.
6. Advise the firm on handling the returned products. The coordinator must witness or otherwise verify the reconditioning or destruction of the products returned under the recall.
CORRECTIVE ACTION:
1. Describe the corrective action taken to correct the immediate problem, e.g., redesign, modify SOP, process validation, etc.
2. Qualify/validate the corrective action.
3. Establish the responsibility to assure that the corrective action would be implemented and satisfactorily completed?
4. Action is taken to prevent recurrence of the non-conformance, e.g., training, increased process monitoring, etc.
5. Information provided to those responsible for the areas in which the non-conformance occurred.
6. To determine changes needed in procedures and to validate and implement the changes.
RECALL PROCEDURE
1. Recall alert: A recall situation exists or is planned; a twenty-four-hour alert will be given to the firm by the authority.
2. Recommendation for recall number: A memorandum should be prepared as soon as the recall number is available & transmitted to the District co-ordinator through the supervisor.
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3. Recall product:
For each recalled product, provide its name; type (eg: tablet, sugar-coated); strength, size, form; route of administration; shipping, or unit package; & a brief description of the product.
Indicate whether it is a prescription (RX) or over-the-counter (OTC) product. If the health hazard is dependent on use, consult the firm’s catalog, the red book or similar sources for that information. Also provide: the brand name, name, address, of the responsible firm the on label; complete copy of all labelling (including product inserts or information sheets) should be documented.
4. Code: List all lot &/or serial number, product number, manufacturer numbers, etc which appear on the product or its labeling.
5. Recalling firm/manufacturer:
Provide complete name & address of the recalling firm & identify the type of firm i.e., manufacturer, importer, own-label distributor. Provide the complete name & address of the manufacturer if different from the recalling firm.
6. Reasons for re-call recommendation:
Provide detailed information as to how the product is defective & violates the related statutes.
a. Include any analytical findings in qualitative &/or quantitative terms, from the firm.
b. Provide inspectional (e.g. GMP) or other evidence, where appropriate.
c. List in chronological order any complaints, injuries, or associated problems with the product. Explain all state involvement in the recall, including sample collection or the analysis, recall agreement or initiation, recall monitoring, and product disposition.
7. Volume of product in commerce: Provide total product distributed, also estimated amount & availability of stocks remaining on the market, at all levels. Include product expiration dates or shelf-life expectancy.
8. Distribution pattern: Report the areas of distribution, the number of direct accounts, and the approximate percentage of each type of consignee. List foreign countries & government military &/or civil units/agencies to which products were distributed.
9. Firm’s recall strategy:
Describe the firm’s planned recall strategy. The firm’s strategy should include the intended course of action when an account that distributed the recalled product is found out of business. Include the date the recall was initiated.
10.Firm official:
Report the name, title, location, & telephone number of the firm official to be contacted concerning the re-call.
11.Audit program:
Report appropriate action taken & also provide details of any publicity issued or planned by the firm, the state or local government. Provide a proposed program for monitoring the recall, include time table for reviewing the recall status.
12.Monitoring recalls:
I. Inspections to monitor recall progress:
- Re-inspect the firm between the initiation & closeout of recall to monitor its progress & verify the recalled product’s disposition.
II. Recall audit checks:
- A recall audit check is a personnel visit, telephone call, letter, or a combination thereof to a consignee of a recalling firm or a user or a consumer in the chain of distribution. It is made to verify all consignees at the recall depth specified by the strategy have received notification about the recall & have taken appropriate action.
III. Conducting the check:
During the audit, the firm should furnish the following information to the authority:
a. Details of the recall
b. Recall strategy
c. About the notification received, understood & followed.
d. Date & method of notification.
e. Amount of product recalled on hand at time of notification.
f. Amount returned & the method of return, amount destroyed & method of destruction.
h. Date of anticipated return or destruction & planned method.
i. If injury reports or complaints been received, furnish report details.
j. Visit the storage sites for the recalled product,check the shelf stock to ensure all recalled product has been identified, removed from areas &properly quarantined.
IV. Audit checks to report:
- If audit check discloses recalled product being held for sale, has not been initiated, document the responsibility for failure to follow recall instructions. An official sample should be collected from these remaining products & encourage the consignee to follow the recalling firm’s instructions.
V. Recall terminated/recall completed:
- A recall will be terminated if efforts have been made to remove or correct the violative product in accordance with the recall strategy or have been made commensurate with the degree of hazard of the recalled product. Written notification that a recall is terminated will be issued by the authority to the recalling firm.
VI.Close-out inspection:
- The final monitoring step is a limited inspection made to verify recall close out by the recalling firm. A memorandum should be prepared duly by the compliance officer, concerned authority. During the closeout inspection, witness destruction or reconditioning of the recalled product is done. If unable to witness the destruction or reconditioning, a written documentation from the firm should be obtained. If hazardous items have to be disposed of requires the firm to file an Environmental impact statement or pre-disposal processing to render the goods harmless.
