Making Quality Healthcare Affordable

Quality monitoring

The quality of the products needs to be verified before shipment. IDA Foundation subjects all product batches to physical inspection. These inspections are performed by qualified personnel at receipt in IDA warehouse or by independent inspectors at the manufacturer site in case of direct shipment.

Batches are checked according to the pre-determined product specifications and packaging requirements, including appearance and shelf life. Depending on the risk and past performance, batches are re-analysed with a predetermined frequency to confirm the quality. The chemical analysis of batches after release is performed with verified methods of analysis in a WHO-prequalified laboratory in India according IDA’s test methods and protocols. Samples of each batch are retained for a period of six years. Product reviews are made and trends are monitored.

At the same time the certificate of analysis provided by the manufacturer is checked. Only if there are no discrepancies, the product batch will be released for distribution by a qualified and authorised pharmacist. The IDA quality approval stamp and signature on each certificates of analysis indicates that the batch was checked and released by our Responsible Pharmacist.

IDA acknowledges WHO/SRA (e.g. USFDA) approval. However, as quality cannot be fully guaranteed by testing only and to assure that these prequalified products are supplied according to the approved dossier, we request essential information from this dossier to be able to verify the batches supplied through IDA by visual inspection, analytical control (e.g. check whether approved API was used) and verification audits.
IDA is following the international product registration standards as provided by the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH).