Complaint handling in pharmaceutical companies,product recall,retention records, distribution records
COMPLAINT HANDLING IN PHARMACEUTICALCOMPANIES,PRODUCT RECALL,RETENTIONRECORDS, DISTRIBUTION RECORDSPREPARED BYS.SUSENA,SSJ COLLEGE OF PHARMACY,M.PHARMACY(P.ANALYSIS&QA)
DISTRIBUTION RECORDSINTRODUCTIONDistribution records are written data related to distribution of drugs(s)from manufacturer to distributors. They are one of the most important recordsrequired by GMP regulations. These records should be maintained in such a waythat a batch related distribution records is easily available.OBJECTIVEThe objective of this guideline is that if there is some adverse drugreaction or some quality defect, the manufacturer should be able to recall thebatch of a drug promptly . The information contained in these records is a key fornotification of customers in the event of a product recall.
CONTENTS OF RECORDProduct Information Describe the product being transfer to a newowner (e.g. drug name, manufacturer, lotnumber, strength, dosage form).Transaction Information Describe the sale, transfer, return or otherdisposition of the product (e.g. quantity, invoicenumber, invoice date).Distribution Information Describe the party selling or transferring ownership of the product (e.g. business name, nameand signature of person).Recipient Information Describe the party receiving the product (e.g.business name and address, date received,name and signature of the person).
DOCUMENTATIONDistribution records include a wide range of documentation such asinvoices, bills of lading, customer‟s receipts, and internal warehouse storageand inventory records.EXAMPLELot # 132A Product 500 mg. Aspirin tabletsQuantity Produced: 500 cases of 12 bottles of 100 tabletsQuantityShipperCustomer DateShippedInitials50 cases ACME DrugDenver, CO10/05/08 JS40 cases ABC MedicalSt. Louis, MO10/09/08 SL150 cases XYZ INCCleveland, OH11/02/09 MJ
INTRODUCTIONA „Complaint‟ simply designates, that something is wrong or not goodenough. Generally in the pharmaceutical industry, complaints are regarding thequality of drug product. A complaint shows customer dissatisfaction about a productand consequently, about a company.OBJECTIVETo immediately recall, investigate or to take remedial measures against thedefective product.TYPESBasically it‟s of three types: -1. Quality complaints: Originate at consumer level and concern with physical,chemical and biological properties or condition of labeling and /or packaging ofthe product.2. Adverse reaction complaints: Due to allergic reactions of any other untowardreaction or fatal reaction or near fatal reaction.3. Other medically related complaints: Include complaints such as lack of efficacy orclinical response.
GUIDELINES 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 Trust your instinctsCONTENTS 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 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(s) & date Action taken by the company Copy of reply sent to complainant
STEPS INVOLVED IN HANDLING OF COMPLAINTSStep 1: Receiving ComplaintsIt is important to have open channels with customers in order to receivetheir suggestions, doubts and complaints. Generally, these channels are toll-freenumbers, e-mails, chat-rooms and P.O. boxes. Whatever the channel, it isnecessary to have a person in charge of receiving the complaints and inputtingthem into an appropriate investigation form that shall be addressed to the QualityAssurance (QA) unit for investigation.Step 2: Technical InvestigationUpon receipt of the investigation form, the QA unit is able to start theinvestigation, which can be divided in two phases: documentation-based andlaboratory analysis. Documentation-based investigation - Consists of checking if this complaintoccurred previously in the same lot or if any nonconformance was found in thelot during its production that could explain the complaint. The primarydocumentation to be reviewed in this step consists of the complaint files and thebatch records.
Laboratory analysis phase - Consists of requesting the Quality Control (QC)laboratory to analyze both complaint samples and retained samples – the reservesamples representative of the lot manufactured.If the customer did not send the complaint sample for analysis, thelaboratory investigation will be carried out only with retained samples. Similar tothe receiving step, it is fundamental that the company elects a person in the QAunit to be in charge of technical investigation of each complaint, e.g. a ComplaintOfficer.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 OOSresults, it is clearly a single unexplained failing product. Non-confirmed complaint - When both complaint and retained samples showedresults in compliance with specifications or when only the complaint sampleshowed OOS results that cannot be considered a single unexplained failingproduct. OOS results in a complaint sample can be attributed to misuse ormishandling.
Counterfeit / tamper suspicion - When the retained sample is within thespecification 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 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 aformal Corrective Action and Preventive Action (CAPA) handling. The criteria forchoosing appropriate action depends on the nature of the complaint, and thecomplaint incidence. If a CAPA is opened, a multidisciplinary team consisting ofrepresentatives of QA, QC, Regulatory Affairs and Production Management must beestablished.As feedback to the customer, the company must write a response letter tothe complainant to explain the investigation approach taken, the results obtainedand any implications, in case the quality problem was confirmed. The customershould be sent a free replacement product together with the response letter, sincethe customer returned the product (the „complaint sample‟) to the company foranalysis and a quality problem was found.
Concerning non-confirmed complaints originating from misuse orinadequate handling of the drug product, even if there is no need for internalcorrective actions, corrective measures should be implemented to provide orientationto the customer.Regarding counterfeit or tampered suspicious complaints, a response lettershould also be sent to the customer, but the Legal Affairs unit must be copied forfurther arrangements.Step 4: Monthly Reports and Trend AnalysisMonthly reports should be elaborated in order to evaluate the amount andthe nature of the complaints received and to perform a trend analysis of thesecomplaints.
RECORDING OF COMPLAINTSIt is the responsibility of the in-charge, Quality control to see that eachcomplaint is recorded, evaluated and reported to the management. Records ofcomplaints 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 detail2. Results of investigation - These should include: - Result of investigation regarding market place, circulation condition andcondition in which the defect was observed Results of investigation of analysis and testing records, production andstorage records3. Evaluation4. Follow up measures - It includes:- Reply to the complainant Remedial action so that complaint of this type should not recur.
DOCUMENTATION OF 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.___________________ Expiry date ______________________ Quantity involved _____________ Total quantity shipped __________________________ Reason for complaint return request ___________________________________ Complaint# _______________________ Product ______________________ Evaluation of complaints1. Physical characteristics _____________________________2. Sign of deterioration _______________________________3. Other observation _________________________________
Quality control findings1. Returned sample __________________________________2. Returned sample re-assay ___________________________3. Initial data _______________________________________4. Quality control comments & suggestions__________________________________________________________________________________________________________________ Quality control ________________ Date ___________________ Complaint# ____________________________________________________ Product ______________________________________________________ Packaging/Labeling/InsertsEvaluation_______________________________________________________________________________________________________________________________________________________________________________ Remarks ____________________________________________________________________________________________________________________
Resultant action taken1. Method, Date of customer notification & authorized action ______________________________________________________________________________________________________________________________________________________________________________________2. Comments __________________________________________________________________________________________________________________________________________________________________3. Completion date for action taken ______________________________4. Quality assurance evaluation___________________________________________________________________________________________________________________________________________________________________________
Customer complaint record bookReportNo.DatereceivedProductnameReceived byProduct lotNo.DateinvestigationstartedDateinvestigationended
DEFINITION“Recall” means a firm‟s removal or correction of a marketed product thatthe Food and Drug Administration considers to be in violation of the laws itadministers and against which the agency would initiate legal action, e.g., seizure.RECALL CLASSIFICATIONFDA classified the product recall depending on the health hazard causedby the product in the following way:1. Class I Recall- A situation in which there is a reasonable probability that the useof, or exposure to, a violative product will cause serious adverse healthconsequences or death.2. Class II Recall- A situation in which use of, or exposure to, a violative productmay cause temporary or medically reversible adverse health consequences orwhere the probability of serious adverse health consequences is remote.3. Class III Recall- A situation in which use of, or exposure to, a violative product isnot likely to cause adverse health consequences.
RECALL POLICY Recall is an effective method of removing or correcting consumer products thatare in violation of laws administered by the FDA. Recall may be undertaken voluntarily and at any time by manufacturers anddistributors, or at the request of FDA. Recall is generally more appropriate and affords better protection for consumers.RECALL STRATEGYA planned specific action to be taken in conducting a specific recall, whichaddresses the depth of a recall need for public warnings and extent ofeffectiveness checks for the recall.Elements of a recall strategy1. Depth of recall: Depending on the product‟s degree of hazard and extent ofdistribution, the recall strategy will specify the level in the distribution chain towhich the recall is to extend.
2. Public warning: The purpose of a public warning is to alert the public that aproduct being recalled presents a serious hazard to health.3. Effectiveness checks:The purpose of effectiveness checks is to verify that all consignees at therecall depth specified by the strategy have received notification about the recalland have taken appropriate action. The recall strategy will specify the method(s)to be used for and the level of effectiveness checks that will be conducted, asfollows: Level A - 100 percent of the total number of consignees to be contacted; Level B - Some percentage of the total number of consignees to becontacted, but is greater that 10 percent and less than 100 percent of thetotal 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.
RECALL NUMBERNumber is assigned by a responsible centre for each recalled product. Thisnumber consists first a letter designating the responsible centre, a 3 or 4 digitsequential number indicating the number of recall initiated by that centre during thefiscal year, and a 4 digit number indicating the fiscal year the recall was initiated.F-100-2010 identifies the 100th recall initiated by the Centre for Food Safetyand Applied Nutrition (CFSAN) in FY-2010.Letter Centre/OfficeF Foods-CFSAND Drugs-Centre for Drug Evaluation and Research (CDER)Z Medical Devices & Radiological Health-CDRHV Veterinary Medicine- Centre for Veterinary Medicine (CVM)B Biologics-Centre for Biologics Evaluation and Research (CBER)N Medical Devices (Voluntary Safety Alerts and Notifications)AAudit Numbers issued by the District performing the recall, the Centres, Officeof Enforcement Division of Compliance Management and Operations[DCMO], or the Division of Field Investigation [DFI] to monitor recalls requiringaudit checks.
RECALL TEAMThe Team is responsible for co-ordinating all aspects of the product recall.A recall coordinator, is to be appointed and members of a recall team identified fromthe various functional areas. Together the team will assist the Recall Coordinator inthe event of the recall.The Recall Management Team list shall be updated at least four times ayear to ensure all names, contact phone numbers and responsibilities of teammembers and alternates are updated.NameAlternatepersonBusinessphoneAfter hoursphoneResponsibilities duringrecallChiefExecutiveOfficerProductionManager Decision making Media communication Contacting accounts CFIA/Healthdepartments contact Obtaining legal counselQ.A ManagerProductionManager Q.A/Technical advisory Complaint investigation DFIA/Healthdepartments contact
LIST OF FORMS REQUIRED FOR THE RECALL Notification of Withdrawal Notification of Recall Recall Log Problem Report QA Incident Hold Form Receiving Log Shipping Log Recipe(s)RECALL PROCEDUREIt basically involves three steps:1. Recall Notification / Inspection – If FDA identifies that a potentially violativeproduct which may lead/has lead to a class I or significant class II recall, aninspection should be made to determine the root cause(s) of the problem(s).2. Inspection Procedures – An important part of your job is to identify the rootcause for the recall and assure the firm has implemented procedures to preventit from recurring.
3. Recall Decision Follow-up – If the firm has decided to recall, do the following: Request that management obtain their FDA District‟s review of recallcorrespondence. If the firm requests guidance in preparing recall communications, provide it inaccordance with your District policy. Obtain an Official Sample of the recalled product. Obtain a complete distribution list of all shipment(s) of the suspect lot(S),including foreign distribution. Advise the firm on how the returned products should be handled.TERMINATION OF RECALLA recall will be terminated when the FDA is confident that product hasbeen removed from market in accordance with recall strategy. FDA‟s written noticeto the regulatee is the real termination.
PRODUCT RECALL CHARTAssemble the Recall Management Team (CEO),(QA Manager), (Plant Manager), (Purchasing Manager)Notify the CFIA / Other Health AgenciesIdentify all products to be recalledDetain and Segregate all products to berecalled which are in the firm‟s controlPrepare the Press Release (if required)Prepare the Distribution ListPrepare and distribute the Notice of RecallVerify the effectiveness of the recallControl the recalled product (s)Decide what to do with the recalled product (s)Fix the cause of the recall if the problem occurred at your facility
INDIAN PHARMACEUTICALS LIMITEDSTANDARD 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 allyour stock of this batch number to our office at:______________________________________________________________________________________________________________________________________________________________________All returned stock or this batch number will be replaced as free of charge. Weapologies for any inconvenience caused to you and thank you for your co-operation.Yours faithfully,G.M. QA/QC Regulatory
INDIAN PHARMACEUTICALS LIMITEDMEDICINE RECALL OR WITHDRAWAL PROCEDURESPress statement:Issued by:Date:Time:INDIAN PHARMACEUTICALS LIMITED, a pharmaceutical company wishes toadvise a single batch.Number ___________________________ of ___________________ has been__________________________________________________________ in patientswere _________________ a serious risk may exist. Patients in possession of thisparticular batch number are requested to refrain from using it.____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
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 NumberPhoneFaxLetterTelexTelegramT.VRadioPress
RETENTION OF RECORDSOrganizations create records through daily business transactions. These recordsare considered active for as long as they are needed to be easily accessible for theorganization to use to perform its current functions.Once a record is no longer useful for performing current activities, itbecomes inactive. But it must be kept, or “retained,” as long as it is needed to meetthe organization‟s administrative, fiscal, legal, or historical requirements. The lengthof time the record must be kept to meet those requirements is referred to as itsretention period.As records grow at an excessive rate and cost the organization resourcesfor its maintenance and storage (regardless of the format), they must be disposedof at the end of their retention period.Disposition is a final administrative action taken with regard to records,and may include destroying them transferring them to another entity, or preservingthem permanently. During the disposition process, records are approved fordestruction or other disposition according to the policies and procedures of theprogram.
REFERENCES1. DISTRIBUTION RECORDS Pg: 180-181 of Q.A Manual by D.H Shah Pg: 530 of How to practice GMP‟s by P.P Sharma http://www.gmp7.com/guidefordocumentationandrecords_cm350.html http://www.enkap.org/docs/subpartj_excerpt_may.pdf http://www.authorstream.com/Presentation/cs_apc_09-993865-distribution-cs-ppt/
2. COMPLAINT HANDLING IN PHARMACEUTICAL COMPANIES Pg: 114 of How to practice GMP‟s by P.P Sharma Pg: 590 of cGMP for Pharmaceuticals by Manohar A. Potdar Pg: 181; 266 of Q.A Manual by D.H Shah http://www.slideshare.net/husna05/complaints-and-recall-handling http://onlinelibrary.wiley.com/doi/10.1002/qaj.398/pdf3. PRODUCT RECALL Pg: 131; 595 of cGMP for Pharmaceuticals by Manohar A. Potdar Pg: 116 of How to practice GMP‟s by P.P Sharma Pg: 154; 266 of Q.A Manual by D.H Shah http://www.fda.gov/drugs/drugsafety/DrugRecalls/default.htm http://en.wikipedia.org/wiki/Product_recall4. RETENTION RECORDS Pg: 177; 267 of Q.A Manual by D.H Shah http://www.arma.org/rim/101/articles.cfm?key=rim101retention http://www.cpa.net/resources/retengde.pdf