Product Quality Defects

Last Updated on August 2, 2023

What is Therapeutic Product Quality Defect?
A therapeutic product quality defect is any defect that can influence a product’s quality. Such defects may or may not cause damage to patients or healthcare professionals. Quality defects may affect certain parts of medicine batches, entire batches or various batches.

Quality defects may arise in certain part of a product or may affect entire batch or more than one batch of a product. Following are the example of possible quality defects in a therapeutic good: –

  • Contamination of product with foreign particles, or if a product is chemically or microbiologically contaminated
  • Product is deviated with regard to its specification e.g. physical appearance,
  • Packaging defects or Printing errors

Why report quality defects to the DRAP?
Upon receiving a quality defect report related to a therapeutic goods, DRAP causes assessment of such report and it may leads to an investigation at the manufacturing site and supply chain of a product. In case of evident quality defects, a recall actions is initiated to remove the defective product from the market. A root cause analysis is carried out to make the products re-conform to the prescribed quality standards.

How to report a Product quality defect to DRAP?
To report a quality defect, please fill out the Quality Defect Reporting Form while mentioning all the necessary information.