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Module 5 Slide 1 of 24 WHO - EDM Part One, Sections 6 and 7 Basic Principles of GMP Complaints and Recalls

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Page 1: Basic Principles of GMP - test.futurebeacon.cotest.futurebeacon.co/wp-content/uploads/2012/10/M05-complaints... · Basic Principles of GMP ... Module 5 Slide 10 of 24 WHO - EDM

Module 5 Slide 1 of 24 WHO - EDM

Part One, Sections 6 and 7

Basic Principles of GMP

Complaints and Recalls

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Module 5 Slide 2 of 24 WHO - EDM

Part One, 7.1

Complaints and Recalls Product Complaint Principle

“All complaints and other information concerning

potentially defective products must be carefully reviewed according to written procedures.”

(WHO GMP)

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Module 5 Slide 3 of 24 WHO - EDM

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

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Module 5 Slide 4 of 24 WHO - EDM

Part One, 6.1

Complaints and Recalls Complaints Handling Principle

All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures

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

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Module 5 Slide 5 of 24 WHO - EDM

Part One, 6.2 – 6.9

Complaints and Recalls Complaints Procedure - I

Designated responsible person May be 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

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Module 5 Slide 6 of 24 WHO - EDM

Part One, 6.2 – 6.9

Complaints and Recalls Complaints Procedure - II

Investigate and review QA review complaint Appropriate follow up actions Review of trends

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Module 5 Slide 7 of 24 WHO - EDM

Part One, 6.4

Complaints and Recalls 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 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

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Module 5 Slide 8 of 24 WHO - EDM

Complaints and Recalls Decision from a Complaint Investigation

Complaint justified

Actions to prevent reoccurrence Ongoing observation of process Recall product may be required

Complaint not justified

Advise customer of findings Appropriate marketing response

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Module 5 Slide 9 of 24 WHO - EDM

Part One, 6.8

Complaints and Recalls Other issues

Regular review of trends required Reoccurring problems Potential recall or withdrawal

Inform competent authority of serious quality problems

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Module 5 Slide 10 of 24 WHO - EDM

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

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Module 5 Slide 11 of 24 WHO - EDM

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

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Module 5 Slide 12 of 24 WHO - EDM

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)

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Module 5 Slide 13 of 24 WHO - EDM

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

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Module 5 Slide 14 of 24 WHO - EDM

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

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Module 5 Slide 16 of 24 WHO - EDM

Part One, 7.1

Complaints and 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)

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Module 5 Slide 17 of 24 WHO - EDM

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

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Module 5 Slide 18 of 24 WHO - EDM

Part One, 7.2, 7.3

Complaints and Recalls Designated Responsible Recall Person

May be 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

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Module 5 Slide 19 of 24 WHO - EDM

Part One, 7.2, 7.3

Complaints and 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

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Module 5 Slide 20 of 24 WHO - EDM

Part One, 7.4, 7.5

Complaints and Recalls Distribution Records

Available to designated person for recall purposes Accurate Include information on: Wholesalers Direct customers Batch numbers Quantities

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Module 5 Slide 21 of 24 WHO - EDM

Part One 7.6 - 7.8

Complaints and Recalls Written progress report and reconciliation

Record progress as procedure followed Reconcile delivered with recovered products Issue final report

Effectivemess of procedures checked

Test effectiveness from time to time

Secure segregated storage of returned goods Essential to keep returned goods away from other goods

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Module 5 Slide 22 of 24 WHO - EDM

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

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Module 5 Slide 23 of 24 WHO - EDM

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

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Module 5 Slide 24 of 24 WHO - EDM

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