Time the pharma industry popped the quality pill
The cost of bad quality can have a
devastating impact on a company, beyond financial liability. In the context of
medicines that impact is on patients.
Though this may seem like an obvious
observation, it formed the central theme of a recent pharma industry conclave,
reiterating the need for a quality-oriented culture in drug companies.
With representation of drug regulators from
India, the US, the UK and France, the conclave came at a time when some of the
industry's top drugmakers are facing regulatory action in foreign markets or
are in the process of remediation efforts. Naturally, the message going out
from the conclave was unambiguous.
There is no place for short-cuts. Companies
need to get their operations right the first time, have early-warning systems
to pick up quality or data transgressions, and they need to identify the root
cause and take remedial actions to fix the problem.
After all, those who fail to learn from
history are doomed to repeat it, said Gerald W Heddell of the UK's MHRA
(Medicines and Healthcare products Regulatory Agency), quoting Winston
Churchill. In a sense, there is nothing really new about the “quality culture”,
he said, referring to an incident in 1972 in the UK linking contaminated
infusion fluids to the deaths of five people.
An inquiry committee under CM Clothier, in
its principal conclusions, said “....no
imminent technological advance in the field of production of intravenous fluids
which will eliminate the need for skillful men devoted to their work.”
After 45 years, these observations are still relevant, said Heddell, stressing
the need for committed leadership, skilled employees and constant vigilance.
Nailing
jelly
Measuring quality culture may be like nailing
jelly to the wall. Nevertheless, what the UK regulator is looking for is
confidence that the company is, and will remain, in control; has an
understanding of how quality impacts the patient; confidence in quality related
decision making and a mature mindset, he said. For instance, compliance at an
employee level should be not just because it needs to be done, but with an
understanding that it was important to the end consumer, the patient in this
case.
Repeating a quote from another company chief,
he said, companies need to reward staff for speaking up and giving them the bad
news to catch a transgression before it flares up into action against them by a
regulator.
Driving home a similar point, Mathew T Thomas,
the US Food and Drug Administration's India office director said that “SOPs”
(Standard operating procedure guidelines) need to get off the shelf and
implemented on the ground.
In India, there are big and small drugmakers
and it was important to bring all together to achieve the quality goal, he
said, adding that India's technology expertise needed to be tapped to track and
trace products etc.
The experience was not very different for
France's regulatory authority, the EDQM. Pointing out that quality was a key
villain in cases of non-compliance found during GMP (Good Manufacturing
Practices) inspections, EDQM's Florence Benoit-Guyod urged drug companies
making the finished medicine and the active pharmaceutical ingredient (API) to
remain committed to quality.
Outlining data integrity non-compliances, the
European Medicines Agency's Brendan Cuddy pointed to incidents where robust
electronic and laboratory systems were absent, leading to data traceability and
security problems.
In fact, data reliability guidelines for the
industry were unveiled by Mckinsey & Co, which has been working with
members of the Indian Pharmaceutical Alliance (a platform for large domestic
drugmakers), organisers of this industry conclave.
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