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

Module 5 Slide 1 of 24 WHO - EDM

Part One, Sections 6 and 7

Basic Principles of GMP

Complaints and Recalls


Part One, 7.1


Product Complaint Principle

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

(WHO GMP)



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


Part One, 6.1


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


Part One, 6.2 – 6.9


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


Part One, 6.2 – 6.9


Complaints Procedure - II

Investigate and review

QA review complaint

Appropriate follow up actions

Review of trends


Part One, 6.4


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



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


Part One, 6.8


Other issues Regular review of trends required

Reoccurring problems Potential recall or withdrawal

Inform competent authority of serious quality problems



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



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



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)



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



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


Part One, 7.1


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)



Definition Recall

Removal from the market of specified batches of a product

May refer to one batch or all batches of product


Part One, 7.2, 7.3


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


Part One, 7.2, 7.3


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


Part One, 7.4, 7.5


Distribution Records Available to designated person for recall

purposes

Accurate

Include information on: Wholesalers Direct customers Batch numbers Quantities


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



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



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



Possible Issues – II

No distribution information/batch records

No access to records

Inability to contact government during holidays/weekends

Disagreement on severity of defect

Documents

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