QualityGuidances

• OBJECTIVE:

To lay down a procedure for handling of Product Complaint.

• SCOPE:

The scope of this SOP is to cover all the product complaints received from any sources like doctors, patients, distributors, retailers or health authority etc.

• RESPONSIBILITY:

QA and all concern departments shall be responsible to follow the procedure mentioned in this SOP.

• ACCOUNTABILITY :

Production Head and QA Head shall be accountable for compliance of the procedure mentioned in this SOP.

5.0       ATTACHMENTS :

Product Complaint Register                                                           -Attachment – I

Investigation Form                                                              -Attachment – II

• PROCEDURE :
  • Any department receiving the complaint must forward it to the Head of QA.
  • Complaint received by any other way of communication (Hand written, email, telephonic) should also be attended.
  • Any acknowledgement, regarding the quality of the product, received from health authority shall also be considered as complaint. It should be recorded and investigated.
  • The Head of QA shall hand it over to his/her subordinator to make the entry of the complaint in the register.
  • The QA person shall make the entry in the register as per format mentioned in Attachment-1.
  • After logging of complaint, QA department has to start the investigation of complaint. QA department has to ,Check the nature of the Complaint, verify the complaint sample if available or control sample & on the basis of initial investigation categorize the complaints into Critical / Major / Minor.
• Critical : Complaints related to defective/ dangerous/ Potentially lifethreatening medicines that predictably or probably could result in to serious health Risk /adverse events or even death. For Example (But not limited to): Wrong Product (Label and contents are different), Correct product but wrong strength, with serious medical consequences, Wrong active ingredient in a multi-component product, Mix-ups of some products.
• Major : Complaints that could cause illness or mistreatment, but are not critical. For example (but not limited to): Mislabelling (Wrong or missing text or figures) Missing or incorrect information (leaflets or inserts) Chemical /Physical contamination Non-Compliance with specification
• Minor : Complaint which may not pose a significant hazard to health, complaints due to secondary packing materials, Shortage complaints, Damage of containers
  • Depending on the nature of complaint QA Head will decide upon the type of investigation to be carried out.
  • Depending up on the complaint, QA may involve representatives of appropriate departments in the investigation e.g. production, quality control, engineering, warehouse etc.
  • The Production Head will check from the corresponding Batch Manufacturing and Packing Record about all the details to see any occurrence of such incident.
  • In case of complaint, which requires some investigation in QC, like analysis of sample or checking control sample, this shall be handed over to QC Head.
  • In both the cases QC Head /Production Head shall give the results of investigation to the Head of QА in writing.
  • The investigation should be extended to any further batches of product that may be affected, or to any other product(s), or the processes that could be affected.
  • QA Head shall review the investigation results. Based on these results will make a report and send it to Managing Director.
  • The Managing Director then along with his marketing team will decide the action to be taken and in turn will inform QA accordingly, so that QA can mention this in their register and close the complaint.
  • For critical complaint, investigation should be started within 3 working days after receipt of complaint & escalated appropriately after relevant information is available. All complaint cases should be closed within 30 working days.
  • In case of complaint regarding any Adverse Drug Reaction or something like that, Head of QA shall send the complaint to Managing Director.
  • The Managing Director along with the Marketing Head will then decide the action to be taken as to recall the product.
  • The complaint records for technical complaint shall be archived for expiry date of product batch + 1 year.
  • Trend analysis evaluation and graphical representation of analytical data

Statistical analysis should be performed to assess the nature of complaint. Since the investigation is performed, graphical representation of parameters (i.e. Critical, Major, Minor, etc.) will be useful to study the historical patterns of complaints and aid in the visual evaluation trends that may translate in abnormal variations. Individual trends shall be analyzed and conclusion shall be written.

• Recommendations and conclusion

All data included in section 6.6 should be evaluated as a whole and these data should be        summarized and recommendations for actions provided. The responsibility for coordination and supervision of follow-up measure is with the QA.

• REFERENCES:

PICs GMP Guideline – PE 009-10

• ABBREVIATIONS:

QA : Quality assurance

QC : Quality control

• DISTRIBUTION LIST :

Quality Assurance

Quality Control

Production

Warehouse

10.0     HISTORY OF REVISION:

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