USFDA gets tough with CGMP in Goa

USFDA, the US health regulator has red-flagged violations of current good manufacturing practice (CGMP) regulations at drug firm Indoco Remedies’ Goa facility. This was after the USFDA team inspected the company’s Goa facility in January 2019.

05 Aug 2019 | By Abhishek Muralidharan

Stating the specific violations, the US Food and Drug Administration (USFDA) said the firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.

Compliance is a critical issue in the pharma space. A pharma official, I spoke to said, “pharma converters who supply to the pharma firms should know established specifications and standards. It is important to have a quality system that ensure the accuracy and integrity of data to support the safety, effectiveness and quality of the drugs (the company) manufacture – plus the information that supplements it."

Pharmaceutical companies like Cipla, GSK Pharmaceuticals, Zydus Cadila have been investing in data analytics and digital tools to sharpen their marketing focus and improve compliance.

According to media reports, Cipla is the first company in the Asia Pacific to upgrade to a cloud-based pharmacovigilance solution. This means, it can provide real-time feedback, automate material flows, capture cost information, and drive a paperless workflow, which reduces waste and scrap. The project was piloted at its Patalganga plant - and the tool has been used to procure direct and indirect materials worth Rs 260 crore.

Tags : US Food and Drug Administration (USFDA),Cipla,GSK,Zydus Cadila;