29/30 March 2023
Data Integrity has become one of the most important GMP compliance issues in past two years. This has enormous consequences for the concerned companies but also for companies and authorities in EU and US. It was the US FDA that has first experienced huge data integrity problems in companies worldwide. Many sites in India have been found to violate GMP requirements by Data Integrity issues. Tests have been repeated and original data have been deleted. This is called "testing into compliance". At the Webpage of the US FDA IPCA products are listed which are impacted by the Import Alert. Two facilities from IPCA have been found to be out of GMP compliance: One in Pithampur (Madhya Pradesh) and one in Piparia (Silvassa) (see also report by FiercePharma).
Products manufactured at those facilities might cause high risks to patients. The quality of the products can not be specified because the original test data were simply deleted. The company IPCA was already known for not meeting the GMP requirements. Already in July 2014 IPCA halts US shipment from the Ratlam plant after FDA found massive GMP violations. As a consequence the Canadian Authority (Health Canada) has banned a huge list of APIs and medicinal products from their market as well. Now they have informed the Bombay Stock Exchange about their problems (see message regarding Import Alert issues by IPCA)
But what are the consequences for companies and authorities in Europe and the US? Authorities might be asked why the same facilities that have been found to be involved in the falsification of data are still allowed to supply to EU patients. For example IPCA is still listed with a GMP certificate for the concerned facilities in EudraGMDP. And EU and US companies need to check very carefully which supplier, partners and own sites they have in India. Quite a few companies have been found to delete data and to perform testing into compliance. FDA has started to check whether companies have checked their suppliers for data integrity. The MHRA has put this on the agenda for their inspections as well.