Product Complaints

OBJECTIVE:

To lay down a procedure for handling Product Complaints.

PROCEDURE :

Any department receiving the complaint must forward it to the Head of Quality Assurance.

Complaints received by any other way of communication (Handwritten, email, telephonic) should also be attended to.

Any acknowledgment, regarding the quality of the product, received from the health authority shall also be considered a 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 the format mentioned.

Depending on the nature of the 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 the corresponding Batch Manufacturing and Packing Record for all the details to see any occurrence of such incidents.

In case of a complaint, which requires some investigation in QC, like analysis of a sample or checking control sample, this shall be handed over to QC Head.

In both cases, QC Head /Production Head shall give the results of the 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 notify Management.

The Management 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 complaints, the investigation should be started within 3 working days after receipt of the complaint & escalated appropriately after relevant information is available. All complaint cases should be closed within 30 working days.

In case of a complaint regarding any Adverse Drug Reaction or something like that, the Head of QA shall send the complaint to Managing Director.

The Management along with the Marketing Head will then decide the action to be taken to recall the product.

The complaint records for technical complaints shall be archived for the expiry date of the product batch + 1 year.