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1 Basic Principles of GMP 4. Complaints and Product recall.

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1 1 Basic Principles of GMP 4. Complaints and Product recall

2 2 Product complaint 1 Ideally, every batch manufacture is a success We do not live in an ideal World i.e. there will be manufacturing failures

3 3 Product complaint 2 some of them will not be identified within the company i.e., there will be inevitably complaints there should be a complaint handling policy… …that may cover also recalls

4 4 Complaints Complaints Handling Principle 1 All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures

5 5 Complaints Complaints Handling Principle 2 –Handled positively and carefully reviewed –Must be seen as important work –Managed by a senior staff member –Thorough investigation of the cause is essential

6 6 Complaints Complaints Handling Principle 3 All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures (cont’d) –A major source of information and learning –Enable possible production defects to be remedied before they lead to a recall. –Necessary actions taken -- even a recall decision

7 7 Complaints Complaints Procedure - I Designated responsible person –May be the authorized person –If not, must advise authorized person of results –Sufficient support staff –Access to records Written procedure describing action to be taken Acknowledge and respond to complainant within a reasonable period Record written and verbal comments

8 8 Complaints Complaints Procedure - II Investigate and review QA should review complaint Appropriate follow up actions Review of trends

9 9 Complaints Records of Complaint Investigation Name of product Name of active substance (INN) if necessary Strength, dosage form Batch number Name of complainant and nature of complaint (cont’d)

10 10 Complaints Records of Complaint Investigation Records, retention sample investigated, other batches reviewed and staff interviewed Result of investigation: “Justified” or “Not justified” If “justified”, actions taken to prevent reoccurrence Sign-off upon completion

11 11 Complaints Decision from a Complaint Investigation Complaint justified l Actions to prevent reoccurrence l Ongoing observation of process l Recall product may be required Complaint not justified l Advise customer of findings l Appropriate marketing response

12 12 Complaints Other issues Regular review of trends required –Reoccurring problems –Potential recall or withdrawal Inform competent authority of serious quality problems

13 13 Complaints 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 (cont’d)

14 14 Complaints Classification of Defects The following system has been found in some countries (but it is not a WHO guideline): –Critical defects –Major defects –Other defects

15 15 Complaints 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 (next slide)

16 16 Complaints Critical Defects Examples –Product labelled with incorrect name or incorrect strength –Counterfeit or deliberately tampered- with product –Microbiological contamination of a sterile product

17 17 Complaints 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 (next dia)

18 18 Complaints Major Defects 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)

19 19 Complaints 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 (next dia)

20 20 Complaints Other Defects Examples –Readily visible isolated packaging/closure faults –Contamination which may cause spoilage or dirt and where there is minimal risk to the patient

21 21 Recalls Product Recall Principle “There should be a system to recall from the market promptly and effectively, products known or suspected to be defective.” (WHO GMP)

22 22 Recalls Reasons for Recall Customer complaint Detection of GMP failure after release Result from the ongoing stability testing Order of the national authorities Result of an inspection Known counterfeiting or tampering Adverse reaction reporting

23 23 Recalls Detection of GMP failure The photo shows an active tablet in the row of placebos in a bi-phasic oral contraceptive blister pack

24 24 EXAMPLE „the same” tablets in the same pack

25 25 EXAMPLE: „the same” coated tablets

26 26 EXAMPLE: an ointment if we have a look inside…

27 27 the same ointment, magnified

28 28 Recalls Definition Recall l Removal from the market of specified batches of a product l May refer to one batch or all batches of product

29 29 Recalls Designated Responsible Recall Person May be the authorized person If not, must advise authorized person of results Sufficient support staff for urgency of recall Independent of sales and marketing Access to records

30 30 Recalls SOP for Recall Established, authorized Actions to be taken Regularly checked and updated Capable of rapid operation to hospital and pharmacy level Communication concept to national authorities and internationally

31 31 Recalls Distribution Records Available to designated person for recall purposes Accurate Include information on: –Wholesalers –Direct customers (if any) –Batch numbers –Quantities

32 32 Recalls Written progress report and reconciliation –Record progress as procedure followed –Reconcile delivered with recovered products –Issue final report

33 33 Recalls Effectiveness of procedures checked –Test effectiveness from time to time Secure segregated storage of returned goods –Essential to keep returned goods away from other goods

34 34 End of Complaints and Recalls Do you have any complaint?

35 35 6. Self-Inspection Basic Principles of GMP

36 36 What is it? The manufacturer itself organises regular on-the-spot checks whether the GMP rules are complied with „Own” team or hired experts Report on deficiencies to the Management

37 37 Self-inspection Narrower meaning: Self-GMP inspection of own production and QC Broader meaning: also –Quality audit of our own quality system –Suppyers’ audit

38 38 Self-Inspection Aim Ensures that a company’s operations remain compliant with GMP Assists in ensuring continuous quality improvement

39 39 Self-Inspection Principle, 1 Should –cover all aspects of production and quality control –be designed to detect shortcomings in the implementation of GMP

40 40 Self-Inspection Principle, 2 Must –recommend corrective action if shortcomings are observed –set a timetable for corrective action to be completed

41 41 Self-Inspection Principle, 3 Special occasions may demand additional self-inspections. For example Recalls Repeated rejections by QC GMP inspections announced by the National Drug Regulatory Authority

42 42 Self-Inspection Principle, 4 Team consist of personnel who can evaluate the situation objectively No conflict of interest No revenge in mind Should have experience as observers of a self-inspection team before becoming team member Lead self-inspector with experience as team member

43 43 Self-Inspection types 1.Self-inspection - informal (daily) Immediate Correction 2.Self-inspection - formal (quarterly) Improve systems 3.QC - Internal Confirm compliance (half yearly)

44 44 Self-Inspection Scope of Self-Inspection Programme - I Written instructions Covering all aspects of GMP: –personnel –premises including personnel facilities –maintenance of buildings and equipment –storage of starting materials and finished products –equipment –production and in-process controls –quality control

45 45 Self-Inspection Scope of Self-Inspection Programme - II - documentation –sanitation and hygiene –validation and revalidation programmes –calibration of instruments or measurement systems –recall procedures

46 46 Self-Inspection Scope of Self-Inspection Programme - III –complaints management –labels control –results of previous self-inspections and any corrective steps taken

47 47 Self-Inspection The Self-Inspection Team, 1 Team leader needs: –authority –experience –may be appointed from inside or outside the company

48 48 Self-Inspection The Self-Inspection Team, 2 Team members, including: –local staff who are familiar with the area –experts in their own field –familiar with GMP –may be appointed from inside or outside the company

49 49 Self-Inspection Carrying Out a Self-Inspection Frequency –May depend on company requirements and the size of the company Report: –results –evaluation –conclusions –recommended corrective measures, if applicable Follow-up action –Company management must evaluate both the report and corrective actions

50 50 Self-Inspection Quality Audit GMP Inspectors should encourage Quality Audits Useful to supplement self-inspection programme but not mandatory Examination of all or part of quality system with specific aim of improving itExamination of all or part of quality system with specific aim of improving it Usually conducted by outside experts or team appointed by management May extend to suppliers and contractors

51 51 Self-Inspection Suppliers’ audits, 1 QC department should have responsibility together with other relevant departments for approving suppliers Ensures suppliers can reliably supply materials that meet established specifications

52 52 Self-Inspection Suppliers’ audits, 1 Avoids trying to test in quality to goods received from dubious sources Before suppliers are approved they should be evaluated Evaluation does not necessarily mean an audit Should take into account the supplier’s history and nature of materials to be supplied

53 53 Self-Inspection Auditing the Self-Inspection Programme - I Check self-inspection programme at end of formal government GMP inspection, not at beginning. GMP inspectors should assess : –the SOP –programmes –checklists or “aide memoirs”

54 54 Self-Inspection Auditing the Self-Inspection Programme - II The SOP should describe teams, process, and frequency of self inspection Company policy may not permit GMP inspector to see actual deficiency reports and corrective actions

55 55 Self-Inspection Auditing the Self-Inspection Programme - III GMP Inspectors should be looking for compliance with the self-inspection SOP - not necessarily at actual deficiencies recorded Seek objective evidence of reports and action

56 56 Self-Inspection Auditing the Self-Inspection Programme - IV Ensure company is not just doing housekeeping or safety audits Check there are “Vertical” as well as normal “Horizontal” audits; both play valuable role in self-inspection

57 57 End of Self-inspection

58 58 5. Contract Production and Analysis Basic Principles of GMP

59 59 Contract Production and Analysis Principle Contract production and analysis must: Be correctly defined, agreed, controlled in order to avoid misunderstandings that could result in inferior product Have a written contract clearly establishing each parties’ duties which... Clearly state how the authorized person when exercising his or her full responsibility releases each batch or issues certificate of analysis

60 60 Contract Production and Analysis General Issues All arrangements must be in compliance with marketing authorization Written contract must cover manufacture, analysis and any technical arrangements Should allow audit of contract acceptor In case of contract analysis, the authorized person must still give final release for sale

61 61 Contract Production and Analysis Responsibilities of the Contract Giver, 1 Must assess competence and compliance of contract accepter with GMP (cont’d)

62 62 Contract Production and Analysis Responsibilities of the Contract Giver, 2 All necessary information must be provided to the contract accepter in order to: –have the operations carried out correctly in accordance with the manufacturing authorisation and other legal requirements –be fully aware of any problems with the product, work, tests that might pose a hazard to premises, equipment, personnel, other materials or other products

63 63 Contract Production and Analysis Responsibilities of the Contract Giver, 3 Authorized person (must be at the Giver!) Batch release in compliance with specifications

64 64 Contract Production and Analysis Responsibilities of the Contract Accepter, 1 Competence –must have the necessary facilities, premises and equipment, both in type and in quantity, to undertake the work. –must have a manufacturing authorization to do this type of work. –its staff must have the necessary qualifications, training and experience to be able to do the work

65 65 Contract Production and Analysis Responsibilities of the Contract Accepter, 2 No subcontracting without approval –to accept a 3rd party, contract giver must be able to undertake audits needed to be reassured that the 3rd party is competent. –All the responsibilities placed upon the contract accepter must be fulfilled by any third party contractor that may be employed No conflicting activities

66 66 Contract Production and Analysis The Contract, 1 Each party’s responsibilities defined Technical aspects drawn up by competent persons Batch release mechanisms; by the authorized person

67 67 Contract Production and Analysis The Contract, 2 Materials purchasing, testing and releasing Production and in-process QC (IPQC) and QC Sampling and analysis; –who takes the sample? –and where?

68 68 Contract Production and Analysis The Contract, 3 Reference standards and retention samples –who keeps them? –where and under what conditions are they stored? Records: –manufacturing –analysis –distribution should be kept by or made available to the contract giver

69 69 Contract Production and Analysis The Contract, 4 Rejection management needs to be described for: –starting materials –intermediate and bulk product –finished product = What would happen to materials that are rejected!

70 70 End of Contract Production and Analysis

71 71 Exam topics

72 72 Complaints and recalls in GMP Principles of complaint handling What to do and to record? Which are the possible decisions? Defect classification (3) How to perform recalls and why? Why distribution records are essential?

73 73 Self-inspection in GMP Meanings Aims, principles Types Scope The Self Inspection Team Speak about the different audits

74 74 Contract production and analysis in GMP Define them. Why they may be needed? Tasks of the Contract Giver Tasks of the Contract Accepter What kind of expertise is needed to formulate a manufacturing contract? Batch release responsibility Subcontracting rules


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