Complaint and recall handling

Seminar onHandling Of Returned Goods Recovered materials and reprocessing & COMPLAINTS AND RECALLS.

Presented By,APARNA.CHALLURIReg.no: 11FJ1SO402

Under the guidance of,

Mrs. NANSRI SAHA

Dept’ of Pharmaceutics

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HANDLING OF RETURNED GOODS RECOVERED MATERIALS AND REPROCESSING

RETURNED GOODS:

• Pharmaceutical products can be returned from market for various reasons e.g. Quality problems , accidental damage of goods etc.• such products when returned from market should have the following action immediately taken on it.i.Physically examine the condition of the goods returned. Also check all the relevant documents.ii.Ask Q.C. department to evaluate the quality of the goods received and take a decision on whether these products can be reprocessed ,recovered or needs to be destroyed.

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iii. If it possible to reprocess and recover, then such products after reprocessing or retesting may be considered for relabeling , repacking and reselling the same.

iv. Q.C. department should evaluate all aspects of the received material.

v. Where even a slightest doubt arises about the quality of the product , it should not be considered suitable for reissue or reuse.

vi. Any action taken should be recorded.

Documents required:• SOP on handling of returned goods 3

Recovered materials:

Recovered materials are defined as “those materials that have been diverted or removed from the solid waste stream for sale, reuse or recycling, whether or not they require subsequent separation and processing

Recovering materials that would otherwise be disposed of as waste is one wayto conserve resources. If done properly, it can benefit the environment, conserve raw materials and reduce energy.

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The addition of all or part of earlier batches , conforming to the required quality , into a batch of same product at pre defined stage of manufacture should be authorized before hand.

The recovery should be carried out in accordance with a defined procedure after evaluation of risks involved, including any possible effect on shelf life.

The recovery should be recorded.

Normally 5 to 10 % of recovery can be added into fresh batch, provided the recovered material is meeting the specifications.

Such additions must be properly authorized and recorded.

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REPROCESSING :

•Rejected production batches should be reprocessed in exceptional situations.•Such reprocessing should be permitted only if the reprocessed batch is going to meet the same specification after reprocessing •A detailed record of such reprocessing should be kept.•Reprocessed batches should be given by means of which, such batches can be identified as reprocessed batches.•Such batches should be separately monitored through out their shelf life.

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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 SYSTEMIt 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 handlingOBJECTIVE: 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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Receiving the complaints/ verbal

Forwarding to heads of QA,QC dept.

Investigation of the complaints

Report(product, complainant, sample, action taken etc. details)

Assigning a specific PCR number Ex: PCR/001/11.

Recalls if any

Maintenance of register of complaints.10

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 CATEGORY

Batch no. Mfg.date expiry date

Packaging/ product quality/ medical.

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 actions

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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 complaintsThe 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.

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The investigation form must include: Information about the complainant: - Name - Address - phone no. - E mailInformation 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.

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.

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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.

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

Laboratory analysis•Analyze complained sample and retained sample.•Send results to QA complaint officer

QA COMPLAINT OFFICER

BASED ON DOC. REVIEW & LAB ANALYSIS , HE FINISHES

INVESTIGATION AND PROVIDES CONCLUSION

CONFIRMED

COMPLAINTS

NON-CONFIR

MED COMPLAI

NTS

COUNTERFEIT/

TAMPER SUSPICIO

N

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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 CUSTOMERSFor 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.

26Contd …

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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CORRECTIVE ACTIONS RANGE FROM QUICK TRAINING

TO CAPA HANDLING.

FEED BACK TO CUSTOMERS WRITE RESPONSE LETTER TO CUSTOMER DELIVER A FREE OFFER PRODUCTSTEP 4: MONTHLY

REPORTS AND TREND ANALYSIS

QA COMPLAINT OFFICER EVALUATES MONTHLY REPORTS.

PARETO ANALYSIS FOR CONFIRMED

COMPLAINTS

STEP 3: CORRECTIVE ACTIONS AND FEEDBACK TO CUSTOMERS

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MONTHLY REPORTS AND TREND ANALYSISMonthly 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. 29

Documentation final product complaint reportNature 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.35

SOP on recallRESPONSIBILITY: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, RegulatoryGM ManufacturingGM, Formulation and DevelopmentMedical advisorVice president - MarketingVice president – International MarketingVice 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”.

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INDIAN PHARMACEUTICALS LIMITED Medicine recall control documentProduct 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 factoryWith 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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NAME OF THE DISTRIBUTED

QUANTITY DISTRIBUTED

QUANTITY RETURNED

QUANTITY ACCOUNTED

TOTAL

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. 41

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. 42

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 43

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. 46

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.

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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 CHARTAssemble the recall management team

Notify health agencies

Identify all products to be recalled

Detain and segregate all products to be recalled which are in the firms

control

Prepare the press release

Prepare the distribution list51

Contd ….

Prepare and distribute the notice of recall

Verify the effectiveness of the recall

Control the recalled products

Decide what to do with the recalled product

Fix the cause of the recall if the problem occurred at your facility

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References1.Us53 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) 53

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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Conclusion: I here by conclude that , all complaints and recalls and other information concerning potentially defective products must be carefully reviewed according to written procedures and corrective action should be taken, it gives the company an opportunity to improve the quality of the product and afford better protection for consumers.

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