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US FDA India pushes for digital technology across pharma plants for transparency in data submission
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Nandita Vijay, Bengaluru
February 23 , 2023
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US FDA India gives top priority to emerging technology and advanced manufacturing across the pharma and biotech industry. The regulatory major sees this as the only way to spur transparency in production processes and bring in the much-needed reliability during audits.
Pharma and biotech companies need to take up the responsibility to ensure quality and tackle defects much before the audits are scheduled, said a panel of regulatory experts from the US FDA and EDQM at the day-long PDA India Chapter meeting titled Regulatory Expectations: The Quality Advantage.
According to Sarah McMullen, country director, US FDA India office, it is imperative that our role as a regulatory authority is to protect the public health by ensuring medicines are free from contamination. It is here the pharma industry and the Indian regulator needs to interact closely with us.
Our objective is to develop a deeper knowledge about the Indian regulatory environment, identify and analyse emerging issues that may impact FDA regulatory decisions about India's pharmaceutical products entering the US market. Therefore, our role is to stay connected to assess the general safety of Indian products and conduct inspections of the FDA regulated medicines to the US market, she added.
Dr. Carmelo Rosa, Director Division of Drug Quality, CDER/OMQ FDA along with Mark Abdoo, Associate Commissioner, Global Policy and Strategy, US FDA noted that it is important to monitor the microbiological quality of the critical area in the manufacturing facility to ensure aseptic conditions are maintained during fill and finish of formulations. Here training of people is key to be able to take on the onus of error free operations.
Stating that a key challenge is that the laboratory records do not include the complete data and that there is also inadequate environmental monitoring, the regulatory officials noted that the focus of the industry should be to reduce deficiencies in plant production processes, decrease animal testing without compromising on safety. "Since disease has no boundaries, our responsibility is to look at adulteration to mitigate health issues,” they said.
This industry has been reporting 483 failures which can be contained if processes in writing are adequate and complete. There needs to be sufficient validation of the aseptic process. The hot topics for 2023 from the regulatory perspective are data integrity and deficient OOS (out-of-specification) investigations, poor facility maintenance including its design, record retention, aseptic manufacturing, drug shortage notification, testing incoming materials, contract manufacturing, excipients, international collaboration, supply chain globalization, delay or refusing inspections, cleaning and cross contamination, stated the US FDA team.
Referring to drug shortages, the regulatory experts said that this was a significant public threat. Therefore it is important to encourage pharma manufacturers to prioritise high quality production and ensure adequate supply and capacity. In the wake of a drug shortage, industry needs to ensure mandatory reporting of discontinuance.
There is a need to share details of the supply interruptions and send proposals for prevention of medicine shortage. It is here transparency is essential to share information whether good or bad in a reliable and complete manner, they pointed out.
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