Q: What Are You Doing to Become a Premier Outsourcing Partner in the Context of FDA’s Recent Shift to a Focus on Quality Culture Rather than Just Metrics?


Natalie Landrito, Marketing Director, STEQ America

A: STEQ America has always acknowledged the importance of quality culture in the overall state of quality of both process and finished product. When a piece of equipment or spare part is purchased from us, we offer services and support in the areas of corrective action, proper training of personnel, and addressing the responsibilities and accountability of employees. We believe in delivering a consistently higher-quality product to customers, from the vendor equipment we sell — which is of the highest industry standards and features regulation-compliant product traceability software — all the way through to the quality process improvements we advise upon. We are committed to supporting our clients not just in management goal metrics, but also in manufacturing-site quality performance.

In order for our clients to maintain a healthy quality culture, we recognize that their employees should have a sound understanding of their jobs and not be afraid to address their uncertainties in relation to the equipment they’re using. That’s why we’ll also provide our full assistance in the areas of calibration, equipment commissioning, IQ/OQ qualification, technical support, process optimization and preventive and corrective maintenance.


Mark Hammond, Commercial Director, Aesica

A: At Aesica, we believe that good quality is simply good business practice. Regulations and compliance are top-down: clearly the FDA is looking to have quality built in, and the pharmaceutical industry needs to address this. What people might not realize is that CMOs and CDMOs are audited on a more regular basis than our pharmaceutical customers, due to our wider offering. Not only do we have regulatory audits, but also customer audits. Our customers rely on our services to be of the highest standard, as well as being efficient and providing value for money.

At Aesica, we believe that good quality is simply good business practice. We have industry-standard methodologies, such as Six Sigma, Lean and
Kaizen, and 5S and Britest tools in place. By having continuous improvement as part of our culture, it means that we are more likely to get things right the first time, thereby increasing productivity and reducing cost. In our manufacturing
business, we have reduced manufacturing process cycle times to deliver an increased output of over 20%, increased production yields by over 15%
and reduced the cost of manufacture.


Robert Nass, Head of Quality and Regulatory Management, MilliporeSigma

A: We are fostering a quality culture – embedding quality in everything we do, from manufacturing to the final product.

Fostering quality has always been an essential part of our overall company culture, despite the robust and standardized processes and global quality-management tools we have in place. MilliporeSigma’s quality mission statement declares that our overarching goal as a partner is to deliver quality – always. We have implemented a global quality initiative this year that includes “Quality Counts” workshops, in which employees focus on how we can understand and “live” quality – especially as a partner for our customers. 

We also collaborate very closely, not only within our Quality and Regulatory Management team, but also across our Life Science functions and the company’s business units. We established a Quality Operations Team/Group Quality Advisory Committee, and we share best practices by bringing the Quality Management Team together at a yearly Global Quality Conference. We also implement programs to fulfill the changing quality and regulatory requirements.

We are committed to a quality culture and continuous improvement.


Mark Rogers, Vice President, USA – Life Science, SGS

A: SGS regards quality as one of its core values and applies this not just to laboratory testing, but to all aspects of its business. This philosophy is implemented by a top-down approach in which the business leaders are accountable for execution in sales, operational activities and strategic considerations. The adage “SGS for Life” has recently been adopted to illustrate the importance that SGS puts on relationships with its clients, and the relationships that are founded on the quality of service that SGS provides. 

Clearly, in the heavily regulated field of pharmaceutical and biopharmaceutical testing, the importance of a strong quality system is paramount. SGS recognizes the necessity for a comprehensive quality system, and therefore maintains quality structures at the local, regional and global levels. While such structures do rely on the regular compilation and tracking of certain metrics, SGS believes that these are secondary to the implementation and maintenance of a robust quality culture, and it seems that the regulators agree with this principle.


Harry Gill, Global Vice President, Operational Excellence, Patheon

A: Patheon utilizes A quality-on-the-floor approach to integrate our quality culture and focus at the shop floor level, which includes reviewing records in real time to providing a faster feedback loop for our shop floor operations clients. Thirty percent of our efforts in our OE program are specifically targeted at improving
quality for clients, and we are actively participating in quality culture efforts pilot-sponsored by one of the leading pharmaceutical professional organizations. 

Additionally, we leverage our operational excellence (OE) program, which has a strong emphasis on employee engagement, as more engaged employees significantly outperform those who are disengaged.  We have a network-wide data integrity program that is purposed to actively engage managers,
supervisors and the shop floor workers.

Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.