CDSCO inspections highlight major problems in pharmaceutical units and testing labs

Under the purview of risk-based inspections, the Central Drugs Standard Control Organisation (CDSCO) carried out a spree of inspections, closely examining 254 production facilities and 112 public testing laboratories, CNBC TV-18 reported on January 6.

The results have exposed a number of flaws in these vital infrastructures, the report claimed.

Inadequate documentation practices, a lack of standardised processes, gaps in analytical validations, a lack of self-assessment protocols, a failure to conduct thorough quality failure investigations, and a lack of oversight in conducting internal product quality reviews are among the major issues that were brought to light during the inspections.

In addition, a number of common difficulties have been discovered, including the lack of testing for entering raw materials, cross-contamination-prone infrastructure defects, a shortage of professionally competent workers, and flawed architecture in the production and testing areas.