Khiếu nại và thu hồi | Tài liệu GMP
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Tài liệu GMP được chia sẻ bởi GMPc Việt Nam - Nhà tư vấn Sáng tạo, Chuyên nghiệp, Toàn diện Dự án Nhà máy GMP (EU, PIC/S, WHO, ASEAN), ISO 13485:2012, ISO/IEC 17025:2005, ISO 15189:2012, ISO 15378:2011, ISO 9001:2008
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Khiếu nại và thu hồi | Tài liệu GMP
- 1. Module 5 | Slide 1 of 22 January 2006 Sections 5 and 6 Basic Principles of GMP Complaints and Recalls
- 2. Module 5 | Slide 2 of 22 January 2006 Complaints and Recalls Objectives To identify the key issues in product complaint and recall handling To understand the specific requirements for organization, procedures and resources To understand and develop actions to resolve current issues applicable to you
- 3. Module 5 | Slide 3 of 22 January 2006 5.1 Complaints and Recalls Complaints: Principle “All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures and corrective action should be taken.”
- 4. Module 5 | Slide 4 of 22 January 2006 5.2 – 5.3 Complaints and Recalls Complaints Procedure - I Designated responsible person: To handle complaint Decide on measure to be taken May be authorized person - if not, must advise authorized person of results Sufficient support staff Access to records Written procedure (SOP): Describes action to be taken Includes need to consider a recall (e.g. possible product defect)
- 5. Module 5 | Slide 5 of 22 January 2006 5.4 – 5.6 Complaints and Recalls Complaints Procedure - II Thorough investigation: QC involved With special attention to establish whether "counterfeiting" may have been the cause Fully recorded investigation – reflect all the details Due to product defect (discovered or suspected): Consider checking other batches Batches containing reprocessed product
- 6. Module 5 | Slide 6 of 22 January 2006 5.7 – 5.9 Complaints and Recalls Complaints Procedure - III Investigation and evaluation should result in appropriate follow-up actions May include a "recall" All decisions and measures taken should be recorded Referenced in batch records Records reviewed - trends and recurring problems
- 7. Module 5 | Slide 7 of 22 January 2006 5.10 Complaints and Recalls Other actions Inform competent authorities in case of serious quality problems such as: Faulty manufacture Product deterioration Counterfeiting
- 8. Module 5 | Slide 8 of 22 January 2006 Complaints and Recalls Classification of Defects If complaint is justified, then there has been a failure of the quality system Once defect has been identified, company should be dealing with it in an appropriate way, even recall The definition of defects is useful The following system has been found in some countries (but it is not a WHO guideline): Critical defects Major defects Other defects
- 9. Module 5 | Slide 9 of 22 January 2006 Complaints and Recalls Critical Defects Those defects which can be life-threatening and require the company to take immediate action by all reasonable means, whether in or out of business hours Examples Product labelled with incorrect name or incorrect strength Counterfeit or deliberately tampered-with product Microbiological contamination of a sterile product
- 10. Module 5 | Slide 10 of 22 January 2006 Complaints and Recalls Major Defects Those defects which may put the patient at some risk but are not life-threatening and will require the batch recall or product withdrawal within a few days Examples Any labelling/leaflet misinformation (or lack of information) which represents a significant hazard to the patient Microbial contamination of non-sterile products with some risk for patients Non-compliance to specifications (e.g. active ingredient assay)
- 11. Module 5 | Slide 11 of 22 January 2006 Complaints and Recalls Other Defects Those defects which present only a minor risk to the patient — batch recall or product withdrawal would normally be initiated within a few days Examples Readily visible isolated packaging/closure faults Contamination which may cause spoilage or dirt and where there is minimal risk to the patient
- 12. Module 5 | Slide 12 of 22 January 2006 Complaints and Recalls Reasons for Recall Customer complaint Detection of GMP failure after release Result from the ongoing stability testing Request by the national authorities Result of an inspection Known counterfeiting or tampering Adverse reaction reporting
- 13. Module 5 | Slide 13 of 22 January 2006 Basic Principles of GMP Sample slide from slide no 13 The photo shows an active tablet in the row of placebos in a bi-phasic oral contraceptive blister pack Detection of GMP failure
- 14. Module 5 | Slide 14 of 22 January 2006 6.1 Complaints and Recalls Product Recalls: Principle “There should be a system to recall from the market promptly and effectively, products known or suspected to be defective.”
- 15. Module 5 | Slide 15 of 22 January 2006 Complaints and Recalls Definition Recall Removal from the market of specified batches of a product May refer to one batch or all batches of product
- 16. Module 5 | Slide 16 of 22 January 2006 6.2 Complaints and Recalls Recall Procedure - I Designated responsible person (should be the "authorized person") To execute and coordinate recalls Decide on measure to be taken Sufficient support staff To handle all aspects and urgency of recall
- 17. Module 5 | Slide 17 of 22 January 2006 6.3 – 6.4 Complaints and Recalls SOP for Recall Established, written and authorized Detailed actions to be taken Regularly reviewed and updated Capable of rapid operation to required level of distribution chain, e.g. hospital and pharmacy level Store recalled products in a secure, segregated area
- 18. Module 5 | Slide 18 of 22 January 2006 6.6 Complaints and Recalls Distribution Records Distribution records available to authorized person and contain sufficient information on: Wholesalers Direct customers Export locations Batch numbers and quantities Including for clinical tests and medical samples to permit effective recall
- 19. Module 5 | Slide 19 of 22 January 2006 6.5, 6.7, 6.8 Complaints and Recalls Progress of recall Monitor and record the progress during the recall Inform all competent authorities of all countries where the given product had been distributed Final report should include reconciliation between delivered and recovered products Record of the disposition of the product Effectiveness of procedure tested and evaluated from time to time!
- 20. Module 5 | Slide 20 of 22 January 2006 Complaints and Recalls Group Session Collect 3 examples of complaints or recalls from your experience Describe the actions to be taken by the company or authority and the implications for all interested parties Suggest a classification of the complaint or recall into critical (life-threatening), major or other
- 21. Module 5 | Slide 21 of 22 January 2006 Complaints and Recalls Possible Issues – I No response to justified complaints Response to unjustified complaints Failure to recall Failure to correct frequent complaints No resources to investigate No senior management support Senior management interference
- 22. Module 5 | Slide 22 of 22 January 2006 Complaints and Recalls Possible Issues – II No distribution information/batch records No access to records Inability to contact government during holidays/weekends Disagreement on severity of defect
Notas del editor
- <number> जुलाइ 28, 2014 We are going to deal with an area of very great importance. The plan for this session is that we will present to you the critical aspects of complaint and recall handling for about 1 hour. You will then go into your groups to work there for about 1 hour. We will then reconvene for a plenary session and feedback, which will last about 1hours. There then a test paper followed by an answer session. This session will conclude the QA/QC aspects of the programme and we will have about half an hour for discussions on any of the issues raised.
- <number> जुलाइ 28, 2014 During this review we will look at the very specific requirements placed upon the organization, the procedures that are required and the resources that are needed, in particular, the people involved. We will also highlight the proper use of information regarding complaints as a tool for overall quality improvement. We then want you to look at some examples of current practice and to look at them with the advantage of hindsight. We expect that you will identify weaknesses in the way that these examples were handled and thus learn from these experiences.
- <number> जुलाइ 28, 2014 The product complaint principle is defined in the WHO GMP. The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization, and do not place the patient at risk because of inadequate safety, quality or efficacy. Complaints must be handled positively and carefully reviewed, and corrective actions must be taken as necessary. This can mean amending a manufacturing process as well as implementing a recall of a defective product from all markets where it has been distributed.
- <number> जुलाइ 28, 2014 First of all a written complaints handling procedure should be available. The basic requirements for such a procedure are: A designated person must be appointed with authority to conduct complaints reviews in accordance with the SOPs. The person designated may be the authorized person responsible for quality control. If not, then that QC person must be kept informed of all complaints being investigated. The designated person must have sufficient staff to be able to review all the complaints received in an effective and rapid manner. They must to be able to access all the relevant records concerning the product under discussion. Required actions are described. The complaint is acknowledged and a response to the customer is provided. Written and verbal comments are recorded.
- <number> जुलाइ 28, 2014 The QC department should be involved throughout the investigation. The investigation should be thorough and fully recorded– and reflect all the details of the investigation in the records. Special attention must be given to try and establish whether "counterfeiting" may have been the cause. If there is a product defect (discovered or suspected), then the company should consider checking other batches, and may have to check batches containing reprocessed product.
- <number> जुलाइ 28, 2014 Investigation and evaluation should result in appropriate follow up actions taken. This may include a "recall" of the product, or batch. All decisions and measures taken should be recorded. The complaint should also be referenced in batch records – and may thus help during the review or annual product review, trend analysis etc. Complaint records should be reviewed on a regular basis as defined in the SOP. Trends and recurring problems should be identified and proper action taken to prevent recurrence of the problem/cause. As complaints are investigated and records are built up, then trends may start to become clear. A regular review of complaint records to establish whether there is a trend for a particular product, dosage form, customer, distribution channel or similar should be undertaken. This is where the true value of a good complaints handling procedure shows. It may be that a particular formulation or particular machine is giving rise to complaints. This trend analysis process is an opportunity for continuous improvement. It may be that a particular customer is engaged in fraudulent behaviour.
- <number> जुलाइ 28, 2014 The competent authority must be informed of any serious quality problems that are revealed by the complaint investigation
- <number> जुलाइ 28, 2014 During complaints handling and especially in recall situations it is important to have clear guidance to define the magnitude of the problem. If an investigation into a complaint proves that the complaint is justified, then there has been a failure of the quality system resulting in a defective product becoming available. Once a very serious defect has been identified, it is important to be sure that the company is dealing with the recall in an appropriate way. How quickly should the company be responding to the problem? The definition of defects therefore is important. We are suggesting here a system of classification that may be helpful. Some countries have different approaches. This system has been in use in a number of countries and found to be useful. Classification of defects: Critical defects Major defects Other defects. This is a very difficult area requiring professional judgement in coming to the correct decision. The company should have procedures to call into operation to decide whether a recall is required and how quickly it should be implemented. These procedures should be discussed and agreed with the regulatory authority.
- <number> जुलाइ 28, 2014 Critical defects are those defects which can be life-threatening and which require the company to take immediate action by all reasonable means, as soon as the defect becomes apparent, whether in or out of business hours. This means that all wholesalers must be alerted and the necessary actions taken to commence recalling the product throughout the distribution chain. This illustrates how important distribution records are, including those of the wholesaler. Examples of critical defects are: Product labelled with incorrect name Counterfeit or deliberately tampered with product Microbiological contamination of a sterile product. It can be seen from the examples that it is critical to patient health that immediate action is taken. It may mean using radio and television news broadcasts to conduct the recall.
- <number> जुलाइ 28, 2014 Major defects are those defects which may put the patient at some risk but which are not life-threatening. They will require the recall of the batch or product withdrawal within a few days. In some countries this is specified as within 48 hours. Examples of major defects are: Any labelling/leaflet misinformation (or lack of information) which represents a significant hazard to the patient Microbial contamination of non-sterile products with some risks Non-compliance to specifications (e.g. active ingredient assay close to limits but out of specification). A country may decide on different time-scales for recalls, depending on the appropriate response for the product or defect concerned.
- <number> जुलाइ 28, 2014 Other defects are those defects which present only a minor risk to the patient. Any batch recall or product withdrawal would normally be initiated within a few days. In some countries this is specified as within five working days. Examples of such defect are: Readily visible isolated packaging/closure faults Contamination which may cause spoilage or dirt and where there is minimal risk to the patient. Again this shows a less speedy response to the situation which is in balance with the level of risk for the patient. Let us summarize at this point: It is important that complaints as well as potential recall situations result in the proper categorization of the problem. This means that the company will then undertake recalls or complaints handling with the correct level of urgency and not unduly alarm patients or the public. It is essential that the public retain a high level of confidence in the supply of pharmaceuticals. This confidence, however, must be justified.
- <number> जुलाइ 28, 2014 A recall situation can result from information entering a company in various ways: Customer complaints – these may be so serious as to initiate a recall. An example could be the evidence of a lack of sterility GMP deviations/results of a failure investigation The result from the QC stability programme Request by the regulatory authorities Result of an inspection Known counterfeiting or tampering Adverse drug reaction (ADR) reported, leading to a recall decision (however, an ADR does not automatically lead to a recall). The company must have a procedure in place that can be operated at all hours to decide how serious a defect is and whether it warrants a recall.
- <number> जुलाइ 28, 2014 Walls, floors, ceilings – smooth and easy to clean No ledges or areas where dust can accumulate Prevention of build-up of dirt and dust to avoid unnecessary risks of contamination
- <number> जुलाइ 28, 2014 The product recall principle is defined in the WHO GMP. The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization, and do not place the patient at risk because of inadequate safety, quality or efficacy. Recalls must be handled positively and carefully reviewed, and actions must be taken as necessary leading to an effective recall of defective product from all markets where it has been distributed.
- <number> जुलाइ 28, 2014 To deal with the topic of recalls we should first review some definitions: Recall is the removal from the market of specified batches or all batches of a product. Some countries refer to the recall of all batches as “withdrawal”.
- <number> जुलाइ 28, 2014 A designated person must be appointed with authority to conduct recalls in accordance with the procedures. The person designated may be the authorized person responsible for quality control. If not then that QC person must be kept informed of all recalls being conducted. The designated person must have sufficient staff to be able to undertake recalls in an effective and rapid manner with appropriate urgency. The designated person should normally be independent of sales and marketing departments and must have the status and authority to be able to carry out the procedure.
- <number> जुलाइ 28, 2014 The recall procedure must be written, authorized by at least the quality control manager, describe clearly the actions to be taken, and include a requirement that it is regularly checked and updated. It must be capable of rapid start-up, out of business hours if necessary. It should include a communications plan to enable all key personnel, and deputies in case of absence, to be contacted outside normal business hours. It is essential that all the authorities in all the countries to which the relevant batch or batches have been sent are informed of the recall. This contact may be done at government level (government-to-government) but not necessarily. It is the manufacturer’s responsibility to ensure that the competent authorities in each country are informed. The manufacturer should also inform importers of the product. The importers will probably be the holders of any product registration and will also know where the product has been distributed. Key contact telephone numbers for all authorities that may need to be contacted should be listed.
- <number> जुलाइ 28, 2014 Essential to the success of any recall is the quality of information contained in distribution records. The company is required to maintain in its records, accurate information on the quantity and batch number of any product it sends to wholesalers or its own direct customers. Full details must be kept of the names, addresses and telephone numbers of all customers. This point raises issues about the records that must be kept by distributors. We have plenty of examples where distributors fail to keep records that can be essential for a product recall. National authorities and manufacturers must continue to exercise pressure to ensure that distributors maintain records at batch number level.
- <number> जुलाइ 28, 2014 As the recall progresses in accordance with the written procedure, written progress reports must be kept showing that all stages of the recall procedure have been adhered to. A reconciliation must also be prepared, showing the total product quantity distributed and the total quantity returned, by batch. It should identify any areas where reconciliation has not been achieved and offer reasons why. A final report must be issued to cover all aspects of the recalls including lessons to be learnt for the future conduct of such recalls. The effectiveness of SOP must also be regularly checked and procedures modified accordingly in the light of any lessons learned. The effectiveness of the recall procedure can be tested by conducting a dummy recall of a particular product. This involves identifying a batch and then conducting a paper recall only to test out the systems. Such dummy recalls should be undertaken not only in normal office hours but also at the weekend and in the middle of the night. As goods are returned, they must be stored in secure storage away from all other goods until their fate is decided. Remaining stock of the suspect batch in the warehouse should also be moved into this secure storage. This is very important because there must be no risk of confusion with other batches that are good.
- <number> जुलाइ 28, 2014 This brings us to our question for the group session. You have one hour for discussion. The purpose behind this question is to get you to use real examples from your experience, examine what was done at the time and then think through what should have been done if all policies and procedures had been designed correctly and implemented properly. Your team here will move around the groups so please use them to help on any contentious issues. We will meet here again at _________ (insert appropriate time).
- <number> जुलाइ 28, 2014 Here are some possible issues that may arise in discussion (If discussion tends not to be lively you may care to use some of these as examples). The company may have difficulty in providing a reasoned response to a justified complaint. Senior management may prefer to ignore justified complaints. There may be an issue of loss of face. The company may have difficulty in confronting a customer with an unjustified complaint. How can the company tell a complaining customer that he/she is mistaken in the belief that the company has done wrong? The company may prefer not to recall a product for a variety of reasons. How do you handle the conflict that might arise in a company between the ethics of doing the right thing and the QA director retaining his/her job, for example? The company may not feel that it has the resources to correct a frequently occurring problem. Instead it prefers to pick up the complaints and handle them. How do you handle the situation where the owner of the company takes the decisions on how product complaints or recalls are to be handled and this does not conform to the GMP way?
- <number> जुलाइ 28, 2014 What are you going to do if there are no correct distribution or batch records of a product that may need to be recalled? How do you handle distributors who refuse to keep distribution records because “no one pays us to do that”? How do you handle the situation where the owner’s son is in charge of sales and distribution and refuses to let the QA manager see the distribution records when the QA manager is trying to investigate a product complaint. The company believes that a product needs to be recalled but it’s the start of the weekend. They need someone in the national authority to discuss the recall. They can’t get hold of anyone! What are you going to do? The company manages to speak to the government and they have a very different view of the urgency of the recall to the one that the company has. What are you going to do?