module 5slide 1 of 24 who - edm part one, sections 6 and 7 basic principles of gmp complaints and...
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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
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)
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
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
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
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
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
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
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
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
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
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)
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
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
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)
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
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
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
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
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
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
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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