Corrective Action Preventive Action (CAPA) focuses on eliminating the root cause of non-conformities It is a systematic approach aimed at mitigating the risks of undesirable events and non-conformities. CAPA forms the core of quality management system (QMS) in...
In this blog, we have curated a detailed guide for starting an IVD manufacturing plant in India. Additionally, we have discussed the necessary CDSCO license required for setting up an IVD manufacturing facility. What are IVDs? IVDs or in vitro diagnostic devices are...
In this update, we have provided the revised list of refurbished medical equipment for import provided by the Centre. Additionally, we have listed the major conditions for importing refurbished medical equipment into India. Revised list of refurbished medical...
In-vitro diagnostic devices (IVDs) are instruments, reagents, or systems used to diagnose a disease or other health conditions. IVD tests are usually performed in test tubes or other similar equipment outside the body. Moreover, the tests can be performed using...
Significant changes in Revised Schedule M guidelines have been introduced to safeguard patients and improve the Indian pharmaceutical industry’s reputation. These new guidelines are aimed at changing the way pharmaceuticals are manufactured in India. For further...