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Complaint handling in pharmaceutical companies,product recall,retention records, distribution records

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Complaint handling in pharmaceutical companies,product recall,retention records, distribution records

  2. 2. DISTRIBUTION RECORDS INTRODUCTION Distribution records are written data related to distribution of drugs(s) from manufacturer to distributors. They are one of the most important records required by GMP regulations. These records should be maintained in such a way that a batch related distribution records is easily available. OBJECTIVE The objective of this guideline is that if there is some adverse drug reaction or some quality defect, the manufacturer should be able to recall the batch of a drug promptly . The information contained in these records is a key for notification of customers in the event of a product recall.
  3. 3. CONTENTS OF RECORD Product Information Describe the product being transfer to a new owner (e.g. drug name, manufacturer, lot number, strength, dosage form). Transaction Information Describe the sale, transfer, return or other disposition of the product (e.g. quantity, invoice number, invoice date). Distribution Information Describe the party selling or transferring owner ship of the product (e.g. business name, name and 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).
  4. 4. DOCUMENTATION Distribution records include a wide range of documentation such as invoices, bills of lading, customer‟s receipts, and internal warehouse storage and inventory records. EXAMPLE Lot # 132A Product 500 mg. Aspirin tablets Quantity Produced: 500 cases of 12 bottles of 100 tablets Quantity Shipper Customer Date Shipped Initials 50 cases ACME Drug Denver, CO 10/05/08 JS 40 cases ABC Medical St. Louis, MO 10/09/08 SL 150 cases XYZ INC Cleveland, OH 11/02/09 MJ
  6. 6. INTRODUCTION A „Complaint‟ simply designates, that something is wrong or not good enough. Generally in the pharmaceutical industry, complaints are regarding the quality of drug product. A complaint shows customer dissatisfaction about a product and consequently, about a company. OBJECTIVE To immediately recall, investigate or to take remedial measures against the defective product. TYPES Basically 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 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.
  7. 7. 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 instincts 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  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
  8. 8. 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 in 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.
  9. 9.  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.
  10. 10.  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 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. 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. 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.
  11. 11. 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: 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.
  12. 12. 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: -  Result of investigation regarding market place, 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 complaint of this type should not recur.
  13. 13. 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 complaints 1. Physical characteristics _____________________________ 2. Sign of deterioration _______________________________ 3. Other observation _________________________________
  14. 14.  Quality control findings 1. Returned sample __________________________________ 2. Returned sample re-assay ___________________________ 3. Initial data _______________________________________ 4. Quality control comments & suggestions _________________________________________________________ _________________________________________________________  Quality control ________________ Date ___________________  Complaint# ____________________________________________________  Product ______________________________________________________  Packaging/Labeling/Inserts Evaluation_____________________________________________________ _____________________________________________________________ _____________________________________________________________  Remarks ______________________________________________________ ______________________________________________________________
  15. 15.  Resultant action taken 1. Method, Date of customer notification & authorized action ___________ _________________________________________________________ _________________________________________________________ _________________________________________________________ 2. Comments ________________________________________________ _________________________________________________________ _________________________________________________________ 3. Completion date for action taken ______________________________ 4. Quality assurance evaluation _________________________________________________________ _________________________________________________________ _________________________________________________________
  16. 16. Customer complaint record book Report No. Date receive d Produ ct name Receiv ed by Produ ct lot No. Date investiga tion started Date investiga tion ended
  18. 18. DEFINITION “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. RECALL CLASSIFICATION FDA classified the product recall depending on the health hazard caused by the product in the following way: 1. 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. 2. Class II Recall- A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where 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 is not likely to cause adverse health consequences.
  19. 19. 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. RECALL STRATEGY A planned specific action to be taken in conducting a specific recall, which addresses the depth of a recall need for public warnings and extent of effectiveness checks for the recall. Elements of a recall strategy 1. 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.
  20. 20. 2. Public warning: The purpose of a public warning is to alert the public that a product being recalled presents a serious hazard to health. 3. Effectiveness checks: The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and 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, as follows:  Level A - 100 percent of the total number of consignees to be contacted;  Level B - Some percentage of the total number of consignees to be contacted, but is 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.
  21. 21. RECALL NUMBER Number is assigned by a responsible centre for each recalled product. This number consists first a letter designating the responsible centre, a 3 or 4 digit sequential number indicating the number of recall initiated by that centre during the fiscal 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 Safety and Applied Nutrition (CFSAN) in FY-2010. Letter Centre/Office F Foods-CFSAN D Drugs-Centre for Drug Evaluation and Research (CDER) Z Medical Devices & Radiological Health-CDRH V Veterinary Medicine- Centre for Veterinary Medicine (CVM) B Biologics-Centre for Biologics Evaluation and Research (CBER) N Medical Devices (Voluntary Safety Alerts and Notifications) A Audit Numbers issued by the District performing the recall, the Centres, Office of Enforcement Division of Compliance Management and Operations [DCMO], or the Division of Field Investigation [DFI] to monitor recalls requiring audit checks.
  22. 22. RECALL TEAM The 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 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. 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 Q.A Manager Production Manager  Q.A/Technical advisory  Complaint investigation  DFIA/Health departments contact
  23. 23. 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 PROCEDURE It basically involves three steps: 1. Recall Notification / Inspection – If FDA identifies that a potentially violative product which may lead/has lead to a class I or significant class II recall, an inspection 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 root cause for the recall and assure the firm has implemented procedures to prevent it from recurring.
  24. 24. 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 recall correspondence.  If the firm requests guidance in preparing recall communications, provide it in accordance 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 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.
  25. 25. PRODUCT RECALL CHART Assemble the Recall Management Team (CEO), (QA Manager), (Plant Manager), (Purchasing Manager) Notify the CFIA / Other Health Agencies Identify all products to be recalled Detain and Segregate all products to be recalled which are in the firm‟s control Prepare the Press Release (if required) Prepare the Distribution List Prepare and distribute the Notice of Recall Verify the effectiveness of the recall Control 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
  26. 26. INDIAN PHARMACEUTICALS LIMITED STANDARD RECALL LETTER Dear 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
  27. 27. INDIAN PHARMACEUTICALS LIMITED MEDICINE RECALL OR WITHDRAWAL PROCEDURES Press statement: Issued by: Date: Time: INDIAN PHARMACEUTICALS LIMITED, a pharmaceutical company wishes to advise a single batch. Number ___________________________ of ___________________ has been __________________________________________________________ in patients were _________________ a serious risk may exist. Patients in possession of this particular batch number are requested to refrain from using it. __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ ____
  28. 28. INDIAN PHARMACEUTICALS LIMITED MEDICINE RECALL OR WITHDRAWAL, PROCEDURE STATUS REPORT Date: _____________ 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 Fax Letter Telex Telegram T.V Radio Press
  29. 29. RETENTION OF RECORDS Organizations create records through daily business transactions. These records are considered active for as long as they are needed to be easily accessible for the organization to use to perform its current functions. Once a record is no longer useful for performing current activities, it becomes inactive. But it must be kept, or “retained,” as long as it is needed to meet the organization‟s administrative, fiscal, legal, or historical requirements. The length of time the record must be kept to meet those requirements is referred to as its retention period. As records grow at an excessive rate and cost the organization resources for its maintenance and storage (regardless of the format), they must be disposed of 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 preserving them permanently. During the disposition process, records are approved for destruction or other disposition according to the policies and procedures of the program.
  30. 30. REFERENCES 1. 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    cs-ppt/
  31. 31. 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   3. 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   4. RETENTION RECORDS  Pg: 177; 267 of Q.A Manual by D.H Shah  