This week at InformEx in New Orleans a panel of industry experts gathered to discuss regulatory and inspections trends in 2016.
Scott Watson, Principal at The C=C Bond Group began the discussion by recalling March 2008, when at least 81 people died in the US due to contaminated heparin.
This event is one of the reasons that the non-profit consortium, Rx-360, was formed. The tragedy was also the reason Mark Paxton, CEO of Rx-360, left pharma to work with the FDA.
“We realized that if we were going to do patient’s justice … needed to work in a venue that would allow us to be more reactive to threats of patients safety,” he explained about the formation of Rx-360.
“We have to do a better job, period," he said. "Not because of the requirements … But because we’re concerned about our patients.”
This year there has been an increased emphasis on companies to know more information about their supplier’s supplier. “We’re digging deeper and deeper into the supply chain,” explained Ben Mills, Pharmaceutical Technical Lead, The British Standards Institute (BSI).
This increasing scrutiny could be problematic for several reasons, as not all suppliers have robust supplier management programs. According to Mills, sometimes it may be nothing more than a questionnaire, if resources are tight.
However, regulatory agencies are looking for deeper insight – “If there’s an issue, a regularity agency will follow the thread,” he added.
Issues may include failure to follow produces, validation issues, or unkempt equipment. Another “hot topic” has been data integrity.
“What do you do with the date you generate?” asked Mills, “Is it maintained in a way that is robust?”
While manufacturers have the ultimate responsibly - everyone shares that responsibly, he explained.
This issue has evolved with technology and increased automation. Specifically, as more tablets are being used in facilities there has been a lack of control around remote devices - for example, with shared passwords.
“There has to be control of data,” said Mills.
But, there’s not a lot of clarity around what data integrity means.
“There’s a lack of understanding … and education is needed,” said Robin Kumoluyi, VP and Global Head of Third Party Operations, Novartis Group Quality, stressing the importance in protecting patients and supply chain security.
Yet, while data integrity may be a “hot topic,” currently, according to Bill Cope, Senior Director, Enterprise Regulatory Compliance, Johnson & Johnson, it is not a new issue.
His advice for maintaining data integrity is becoming familiar with the processes and understanding what can be done to prevent errors.
“We’re all dealing with changing landscapes,” added Cope. “We’re all trying to stay ahead of that.”