COMPLAINTS AND RECALLS HANDLING.

PRESENTED BY,HUSNA KANWAL QURESHI.M.Pharm, 1st yr, 2nd sem.UNDER THE GUIDANCE OFDr. T. MAMATHA M.Pharm, Ph.D.QUALITY ASSURANCE.

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COMPLAINT HANDLING

DEFINATION OF COMPLAINT:• “Complaint is defined as statement that is

something wrong or not good enough, which shows customer dissatisfaction about the company and the product”.

Example: Complaint about packaging materials, Concerning about the product etc.

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NEED FOR COMPLAINT HANDLING SYSTEM

• It gives the company an opportunity to improve the quality of the product

• It is helpful to maintain cGMP • It maintains committed relationship between

the customer and company • It is the regulatory obligation.

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SOP on complaint handling• OBJECTIVE: To lay out the procedure for investigation

and reporting the market complaints.• RESPONSIBILITY: The quality assurance manager along

with manager of the complaint related department.PROCEDURE:• Complaints shall be classified in following

categories to facilitate investigation:• Product quality complaints (non therapeutic).• Packaging complaints (shortages and packaging error).• Medical complaints (therapeutic problems).

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Time period for investigation after receipt of complaints:

• Product quality complaints – within 5 days.• Packaging and quality complaints – within 10

days.• Medical complaint – within 3 days.Complaint records shall be maintained at least

one year after expiration date of medicines.Complaint records shall be reviewed and a

monthly summary shall be prepared for the management.

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PRODUCT NAME COMPLAINT CATEGORYBatch no. Mfg.date expiry date Packaging/ product quality/ medical.

Packaging details:Name / address of the complainant:Complaint reported through:

Complainant sample enclosed: yes / noQuality of sample enclosed:Investigation report

Total quantity involved

PCR received by

On:Investigation done by:

Action taken Conclusion:Confirmed/not confirmedPCR no:PCR approved by:

recommended corrective actions7

Product complaint data sheetProduct complaint data sheet should have the

following details:• Serial number assigned to the complaints.• Exact nature of the complaints.• Name of the complainants.• Address of the complainants.• Date of complaint received.• If verbal, name of the person who received the

complaint.• Name of the product, strength and batch number of

the product.• Reference to analytical record number.

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• Quantity involved in the complaint.• Size of sample obtained from the complainant.• Evaluation of complaint by QC department.• Materials and records used to perform evaluation.• Other possible effected materials, products and

results of their investigation.• Name and signature of the investigator(s) and date.• Action taken by the company.• Copy of reply sent to complainant.

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Steps in handling of complaints

The proposed handling system is in compliance with the GMP Guidelines of EU, USA and Brazil and is presented in four steps:

1.Receiving complaints.2.Technical investigation.3.Corrective actions/feedback to Customers.4. Monthly reports/trend analysis.

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Receiving complaintsIt is important to have open channels with 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.

• The most flexible channels are toll-free numbers and chat-rooms.

• A person must be appointed in charge of receiving complaints and inputting them into appropriate investigation form that shall be addressed. 11

The investigation form must include: • Information about the complainant: - Name - Address - phone no. - E mail• Information about the drug product - Product name - Lot no - MFG & Exp date - Amount of the product with the problem. - Detailed description of the complaint.

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customer

Company's contact person

QA complaint

officer

Make a complaint through toll free no., E-mails, P.O.

Box

•Open the investigation, including information about the customer and about the complaint(product name,

lot no., mfg & expiry date and complaint description.)

•Ask the customer to return the product for analysis.

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Technical investigationUpon receipt of the investigation form, the QA unit is

able to start the investigation.It is divided into two phases:• Documentation based investigation.• Laboratory analysis.Documentation based investigation: : The primary documentation to be reviewed consists of: Complaint files: This is constituted to check how many

other complaints of the same nature had occurred to a specific lot and how they were handled.

Batch records must be verified in order to see if there were any non-conformance during the production. 14

Laboratory analysis phaseIt consists of requesting the Quality Control (QC)

laboratory to analyze.• Complaint samples.• Retained samples.Complaint samples are the customer sample.Retained samples – the reserve samples representative

of the lot manufactured (which were kept under appropriate conditions of temperature, humidity and light so that the drug product was not affected).

The company elects a person in the QA unit to be in charge of technical investigation of each complaint, e.g. a Complaint Officer. 15

Documentation based•Check complaint files for previous complaints of same nature.•Check batch records.

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There are three possible conclusions, as follows:• Confirmed complaints.• Non confirmed complaints.• Counterfeit/ tamper suspicion.CONFIRMED COMPLAINTS: • When both complaint and retained samples showed out-

of-specification (OOS) results or when only the complaint sample showed OOS results.

Example: • a single unexplained failure may be when one tablet is

missing in the intact blister strip in the complaint sample, but no deviation was found in the retained samples or during the in-process controls and final QC analysis recorded in the batch record.

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NON-CONFIRMED COMPLAINTS: • When both complaint and retained samples showed

results in compliance with specifications or when only the complaint sample showed OOS results.

• OOS results in a complaint sample can be attributed to misuse or mishandling, when the drug product was not kept under appropriate conditions of temperature, humidity and light so that the identity, strength, quality and purity of the drug product could be affected.

Example: Tablets of the complaint sample show a change in

their appearance that is characteristic of a light, humidity or high temperature exposure.

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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.

Example:• when packaging material is different from the

original; an example of tampering is when the color of the drug product is completely different from the original or when any foreign substance was added to the product.

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The Complaint Officer must also check if the complaint represents a serious and unexpected adverse drug experience.

The Complaint Officer and the QA Manager must sign off the investigation form once the investigation is completed.

30 days is a reasonable time to conclude an investigation.

Complaint files should be retained for at least 1 year after the expiry date of the lot.

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CORRECTIVE ACTIONS AND FEEDBACK TO CUSTOMERS

For all confirmed complaints, corrective actions must be implemented. These actions can range from a simple and quick training to some employees to a formal Corrective Action and Preventive Action (CAPA) handling.

• 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. The customer should receive a written response together with scientific information on the correct use and handling.

21Contd …

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.

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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.

The monthly reports must answer the following questions: How many complaints did the company receive in the period? How many were confirmed? How many were non-confirmed or were counterfeit/tamper

suspicion?• Graphic methods of displaying data are important adjuncts to

data analysis and presentation.• The report must be readily available mainly during GMP

inspections. 24

Documentation final product complaint report

• Nature of the complaint--------------------------• Date------------------• Complaint:-------------------------• Originator of the complaint & title ----------------------------• Distribution contact person & title ----------------------------• Method of notification----------------------------• Name------------------------------------------------------• Phone No.------------------------------ P.O#--------• Date shipped-------------Invoice#-------• Product name:----------------- Control no:----------• EXP date:---------------- Quantity involved---------------------

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• Total quantity shipped----------------------------------------• Reason for complaint return request--------------------------• Complaint#------------ Product--------------------• Evaluation of complaints: 1.Physical characteristics------------------------- 2.Sign of deterioration ---------------------------- 3.Other observation--------------------------------• Quality control Findings: 1.Returned sample-------------------------- 2.Returned sample re assay--------------- 3. initial data-------------------------------------

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• 4.Quality control comments & suggestions ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

• Quality control-------------------,Date--------------------• Complaint#____________________________________• Product_______________________________________• Packaging/Labeling/Inserts

evaluation_______________________________________________________________________________________________________________________________

• Remarks___________________________________________________________________________________

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Resultant action taken:• 1.Method,Date of customer notification & authorized

action_____________________________________________________________________________________

• 2.Comments_____________________________________________________________________________________________________________________________

• 3.Completion date for action taken _______________• 4.Quality assurance evaluation

_______________________________________________________________________________________________________________________________

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Customer complaint record bookReport no.

Date received

Product name

Received by

Product lot no.

Date investigation started

Date investigation ended

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RECALL HANDLING ‘‘Recall’’ means a firm’s removal or correction of a marketed

product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.

The main objectives of this recall plan are:• 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.30

SOP on recall• RESPONSIBILITY: General manager / vice president: (QA/QC, Regulatory)• General Manager: manufacturing. In case of adverse event a committee evaluates the crisis. It

consists of following individuals:• GM/V.P/QA/QC, Regulatory• GM Manufacturing• GM, Formulation and Development• Medical advisor• Vice president - Marketing• Vice president – International Marketing• Vice president – Technical Operations

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PROCEDURE: Any employee becoming aware of such medicine should

immediately notify to higher authorities. Immediately quarantine existing in-house of relevant

medicine. Record the following information:a) The product name, strength, packs size, batch no., mfg and

expiry date.b) The total number of units released for sale.c) Date on which distribution commenced.d) Total number of units distributed.e) Number of units still in stock.f) Nature of reported violation. In the light of above information higher officials evaluates the

health hazard presented by the violation medicine and documents it on “ medicine recall control document”. 32

INDIAN PHARMACEUTICALS LIMITED Medicine recall control document• Product information:1. Manufacturer ---------------------------------------------------------------2. Product name---------------------------------------------------------------3. Strength-----------------------------------------------------------------------4. Pack size--------------------------------------------------------------------5. batch number ---------------------------------------------------------------6. total number of units originally released for sale: _________7. Date of which distribution commenced: ______________8. Total number of units distributed: _____________________9. Number of units still in stock:• At factory• With stockiest (s)10. The nature of the reported violation: __________________________________________________

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Formulating a proposed recall strategy. It specifies the nature of communication to be used (phone, fax, telegram, letters, telemail, etc) as well as the level in the distribution chain to which recall is extended.(wholesalers, retailers, public, etc).

Relevant records shall be submitted to regulatory authorities with proposed plan of action.

INDIAN PHARMACEUTICALS LIMITED Medicine recall control document3. RECALL STRATEGY3.1. Nature of communication (phone, fax, telegraphs, letters,

news papers, etc.) __________________________________________________ __________________________________________________

Depth of recall: (Wholesalers, retailers, general public) __________________________________________________

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The GM, QA/QC Regulatory or GM manufacturing implements recall without delay.

They also prepare an interim reconciliation report after 30 days and submit a copy to concerned authorities.

After that prepares a final reconciliation report after 90 days and submits a copy for verification of the success of recall.

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• Signature of GM, QA/QC Regulatory G.M. manufacturing should be taken.• Steps should betaken to prevent the re-occurrence. Prior to completion of recall the following points should be

considered:• Method of destruction of the product .• A designed area to receive returned medicines.• Inventory of medicine.• Destruction authorization. The recall will be terminated when the GM, QA/QC

Regulatory or GM manufacturing are assured that recall has been completed reasonably and a “medicine record status report” is completed.

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INDIAN PHARMACEUTICALS LIMITEDMEDICINE RECALL OR WITHDRAWAL, PROCEDURE STATUS REPORTDate: ________ product: ___________ Strength:____________Pack size: ____________ B.no: _________Exp.date: ________Nature of defect: ____________________________________Reason for recall: _____________________________________Indication of health risk or any other reason: ________________Reported clinical problems: ______________________________Method of communication to users:Method Action Date Target Group Number• Phone• Letter• Telegram• TV• Radio, Press etc.

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GM, QA/QC Regulatory or GM manufacturing shall prepare a “ Standardized recall letter” and “press statement”.

INDIAN PHARMACEUTICALS LIMITED STANDARD RECALL LETTERDear customer: It has come to our notice (product name) _______________

having batch number ______________ or has shown ________ please refrain from prescribing or dispensing any of this batch number and return all your stock of this batch number to our office at: __________________________________________

All returned stock or this batch number will be replaced as free of charge. We apologies for any inconvenience caused to you and thank you for your co-operation.

Yours faithfully,G.M. QA/QC Regulatory 38

After the authorization by GM, QA/QC Regulatory or GM manufacturing, the recalled material along with stock in hand shall be destroyed and that should be recorded.

RECALL CLASSIFICATION: FDA classified the product recall depending on the health hazard

caused by the product .(1)Class I is 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.

(2)Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

(3)Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

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RECALL POLICY:• Recall is an effective method of removing or correcting

consumer products that are in violation of laws administered by the FDA.

• Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of FDA.

• Recall is generally more appropriate and affords better protection for consumers. Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by the Food and Drug Administration.

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HEALTH HAZARD EVALUATION:• An evaluation of the health hazard presented by a product

being recalled or considered for recall will be conducted by an ad hoc committee of Food and Drug Administration.

• It involves the assessment of hazards to various segments of the population, degree of seriousness, likelihood of occurrence, consequences etc.

RECALL TEAM:• A recall coordinator is to be appointed and members of a

recall team identified from the various functional areas.• All members must ensure that all procedures are carried out

effectively and efficiently. The team should receive appropriate training.

• The Recall Management Team list shall be updated at least four times a year.

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NAME ALTERNATE PERSON

BUSINESS PHONE

AFTER HOURS PHONE

RESPONSIBILITIES DURING RECALL

Chief Executive Officer

Production Manager • Decision

Making• Media

Communication

• Contacting Accounts

• CFIA,/ Health Departments Contact

• Obtaining Legal Counsel

Quality Assurance Manager

Production Manager

Quality Assurance / Technical Advisory

Complaint Investigation

CFIA / Health Departments Contact

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RECALL STRATEGY:(1)A recall strategy that takes into account the following

factors :(i) Results of health hazard evaluation.(ii) Ease in identifying the product.(iii) Degree to which the product's deficiency is obvious to

the consumer or user.(iv) Degree to which the product remains unused in the

market-place.(v) Continued availability of essential products.

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Elements of a recall strategy: Depth of recall. Public warning. Effectiveness checks:• Level A--100 percent of the total number of consignees to be

contacted.• Level B- greater that 10 percent and less than 100 percent of

the total number of consignees.• Level C--10 percent of the total number of consignees to be

contacted.• Level D--2 percent of the total number of consignees to be

contacted.

• Level E--No effectiveness checks.44

• TERMINATION OF RECALL:• A recall will be terminated when the FDA is

confident that product has been removed from market in accordance with recall strategy. FDA’s written notice to the regulatee is the real termination.

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PRODUCT RECALL CHART

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Contd ….

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References1.Us48 Food &drug administration.21 code of federal

regulation-part 211.198.2. Current good manufacturing practices of

pharmaceuticals - Manohar . A . Potdar.3. How to practice GMP By P.P. Sharma4. Validation in pharmaceutical industry by P.P. Sharma.5. Recall Manual

(http://www.google.co.in/#sclient=psy&hl=en&source=hp&q=RECALL+MANUAL&pbx=1&oq=RECALL+MANUAL&aq=f&aqi=g2g-v2g-m1&aql=&gs_sm=e&gs_upl=30014l34331l0l35759l13l12l0l0l0l0l1466l12191l6-4.7l11l0&bav=on.2,or.r_gc.r_pw.&fp=259c071b4fb78fb5&biw=1358&bih=566)

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References 6. Complaint Handling in Pharmaceutical Companies Glaucia Karime Braga*; Faculty of Pharmaceutical

Sciences, University of Sao Paulo, Brazil. 7. WHO technical reports series, No. 908, 2011. 8. Good Manufacturing Practices for pharmaceuticals –

A Plan for total Quality control from manufacture to consumer 5th edition - Sidney H. Willig.

9. www.interscience.com 10. www.google .com11.www.photobucket.com

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