Indian manufacturers struggling to stay on top of data integrity issues, EY survey finds
The survey comes as the Indian industry – now with the second-largest number of manufacturing facilities outside of the US – has also received 8 out of the 19 US FDA warning letters from 2014.
And while the majority of Indian pharma industry professionals say they are aware of GMP (good manufacturing practice) guidelines, more than 30% were hit with inspectional observations from regulators over the last three years, according to EY’s Fraud Investigation & Dispute Services survey of over 170 industry respondents.
Import alerts issued against Indian plants in 2013 also accounted for 49% of the total 43 imports alerts issued by the US FDA worldwide. The survey comes as the European Medicines Agency recently suspended the use of about 700 drugs after India’s GVK Biosciences was cited for data integrity issues in some clinical trials tied to the drugs’ approvals.
Arpinder Singh and Rajiv Joshi, the EY partners who wrote the report, are not only calling on pharma companies to undertake regular data integrity assessments to identify potential gaps, but also the growing contract manufacturing units and small and medium enterprises -- both of which they say are “now keen to upgrade their computer systems and facilities to meet regulatory guidelines.”
The authors said that the main issues causing these data integrity problems include a shortage of staff well-trained in GMPs, and pushes for quantity over quality where employees may feel forced to meet production targets or dispatch timelines.
In addition, while a company may hire international trainers to help employees understand GMPs, the authors say that “employees mentioned that there were language and accent barriers, which prevented the employees from understanding the content, thereby making the training redundant.
“Manufacturing drugs for patient well-being is the most important responsibility of a pharma company; and so is maintaining data to ensure traceability of a batch to its origin. Data integrity asserts that data records are accurate, complete, attributable, legible, and intact and maintained within their original context, including their relationship to secondary data records,” the authors write.
The survey also found other potential violations. Twenty-one percent of those surveyedsaid that audit trails on lab equipment are not always enabled in their organizations, while 33%have shared login ids and passwords for laboratory systems. Another major problem is that a growing number of companies -- 18% --are not adequately staffed to review the manufacturing and testing of all the products independently.
The authors said the rise in observations from regulatory inspections “could raise questions on the effective implementation of GMP norms.”
