“Having inspected companies across the world, I’ve observed that a country’s culture has a great impact on the implementation of quality systems … Usually the team [for a biopharma company or NGO/donor] that decides on a grantee or production partner for vaccines does not include both: (a) someone who can predict the credibility of the candidate based on the potential for a sustainable quality system, and (b) diagnose the reliability of the company's promises.”
So writes Dr. Liliana Chocarro, veteran quality specialist in the global vaccine arena, and researcher in the field of social anthropology and organizational culture, in a response to my recent editorial, Levels Of Risk Severity In Biopharma's Global Outsourcing.
In fact, Chocarro, President and Principle Consultant, LC Plus Consulting Inc., conducted her research to augment her expertise in development, production and regulation of biological products – particularly vaccines –to find an explanation for her real-life observations on how different cultures interpret and implement quality systems.
“There are elements that help qualify a potential production partner,” she says. “Hopefully, executives from sponsor organizations pay attention to these components early on in the process.”
Unfortunately, her lessons-learned come from too many of the opposite experiences. In her describing these, she also details for us an important segment of the global vaccine industry.
A Delicate Discussion
“This is such a delicate issue,” Chocarro begins, “that even when I wrote my thesis on this subject, I had to code the countries and the companies.”
“But basically, I found that in certain cultures, the way they are structured and their behavior, goes against the principles of quality management.”
She gives as the example of a hierarchal culture where junior staff can never tell the senior staff: ‘We’re doing something wrong.’
“That goes against the principles of quality management,” Chocarro says. “When quality management is well-implemented, anyone should be able to say, ‘We need to improve this.’ Top management should then support a critical analysis, provide required resources to make improvements, and then measure again. Continuous improvement is key in quality management.”
However, within the parameters of several cultures, employees are less prone to follow the tenants of quality – such as informing managers – or customers – when things go wrong.
“I’ve been part of many projects to assess or implement quality systems, where funding had already been committed as a financial grant to a company in a developing country to produce a certain vaccine. However, they simply did not look at all the aspects before deciding. The decision was made on the belief that the company had the knowhow, and could deliver if they just had financial help to improve their facilities and equipment. We’re talking about millions of dollars based on the contract organization simply saying they have the capacity, they have the facilities, they have the staff.”
Little of that, unfortunately, can turn out to be true.
Attempts To “Network”
Chocarro explains there are manufacturers in developing countries that have become part of the Developing Country Vaccine Manufacturers Network (DCVMN), creating a list of reliable manufacturers. The thinking of sponsor organizations is: We’ll support these manufacturers, thereby supplying quality vaccines to the populations, and assisting the development of the entire country.
There are also the “wannabe” manufacturers, looking to improve to a status of more recognized quality and reliability.
“Nonetheless,” laments Chocarro, “sponsors/donors, and companies looking for a partner to take over development from phase one onwards, still have a limited vision of how production in a regulated environment actually works. Frankly, I’ve had experiences where I wondered how could this company we are auditing be licensed to manufacture a biological product? What kind of inspection could have been conducted by the regulatory authorities?”
Chocarro says manufacturers in developing countries first promise sponsors, and then insist to her, for example, that they can have phase-one clinical lots ready in six months. But knowing the processes and the requirements as she does, she often draws a new Gantt chart showing that “even if everything goes well, and there are zero delays, it’s going to take about 24 months.” In many cases, she adds, “the starting materials have not been produced and qualified properly, so months’ of work is already lost.”
“Some projects with overseas partners,” she says, still obviously incredulous at the experiences she has had, “turn into a money pit.”
Some Good In The Bad
The mere sharing of her experiences with us is valuable. Those, and her research, have pointed to specific tendencies in several cultures that are simply not amenable to GMP manufacturing. A crucial one, as mentioned above, is the reluctance to speak truth to power when issues arise.
Moreover, regulatory agencies themselves can be influenced by their country cultures. The real, as-applied strength of the regulatory authority overseeing compliance with GMP is critical. Country or regional regulatory agencies cannot allow manufacturers who do not meet standards, to somehow keep their plants open.
But even with culture stacked against them, Chocarro has found companies can reach higher standards. They develop their own organizational culture compatible with the greater principles of quality management. In her research, Chocarro concluded that although implementation of ISO 9000 or TQM (Total Quality Management) is not compulsory, only those pharmaceutical companies that have the maturity, and ethics, to implement and maintain a quality system of that kind could successfully implement and maintain Good Manufacturing Practices standards. They will do this regardless of what is required by their national regulatory authority.
How might that look in practice?
Chocarro replies that “practice” is the optimal word – as in the learning of and then insistent instilling of first-world “best practices.” That successful instillation of best practices relies above all else on the understanding of quality systems, cGMP and the firmest of commitment, by top management.
“The top management must understand what quality management is,” she says. “They have to be behind it, they have to respect it, and they have to listen to the inputs from technical staff. I’ve seen companies like that in countries where the cultural parameters would indicate an opposite tendency. Executive and senior management can create their own quality culture within their organization. And everybody is committed to it.”
And how can vaccine sponsors – or for that matter, drug sponsors of any kind looking for CDMOs and other local drug manufactures to hire – determine which have overcome the impediments of the country culture?
“I would tell them,” she says, “make sure that the team you have assessing a prospective partner or grantee in another country has all the qualities to ensure success. Quality management is not industry specific, but individuals knowing the processes and procedures of our industry is vital. Therefore, understanding if the company culture is compatible with quality management principles is a combination of skills, and to making decisions regarding your investments in overseas partners, be it by manufacturing contracts or grants.”