Safety and (quality) F.I.R.S.T.


As the market for contract services continues to grow, pharmaceutical manufacturers and biotech companies seek a lengthy list of attributes when selecting the right CMO for their needs

Lester Rodriguez VP of Quality,  Pharma Tech Industries

Lester Rodriguez VP of Quality, Pharma Tech Industries

Many companies are looking for long-term strategic partners, and they often find themselves stymied in their search for the elusive CMO that can replicate in-house manufacturing production capabilities for increasingly complex drug formulations.

But, at its heart, pharma is a necessarily cautious industry. So, in addition to looking for advanced technical capabilities and expertise in their outsourcing relationships, many pharma companies are searching for partners dedicated to — and capable of — taking a true problem solving approach to the inevitable challenges of modern pharmaceuticals production.

In a serious business, pharma companies are looking for CMOs that take quality equally seriously.

One way to ensure quality is to make sure it permeates the CMO’s corporate culture. To that end, some CMOs — such as my company, Pharma Tech Industries, a global leader in manufacturing and packaging powder-based products — are creating internally branded quality control and assurance programmes that serve to get the entire organisation in a quality first mindset.

Pharma Tech Industries recently launched the Fast Investigation Response Solving Team (F.I.R.S.T.) to quickly determine the root cause of any quality control deviation that occurs. The group amounts to a dedicated, cross-disciplinary unit that quickly responds to production deviations and, in doing so, shortens typical investigation times.

The ultimate goal, of course, is to best ensure on-time, defect-free delivery of customer projects. The team is composed of members from a variety of core groups — including Safety, Engineering, Quality, Operations and Facilities — and has the authority to enlist personnel from any additional department relevant to a specific quality issue.

Branded programmes such as F.I.R.S.T. allow CMOs to both fulfil and showcase their promise of providing exemplary quality assurance and, through this commitment, best possible experiences to its customers. It works by empowering key personnel to effectively fast-track any quality control issue by expediting the initial steps, which include segregation of the product, realisation of the issue, and restarting production as quickly as possible.

From there, processes are reviewed and discussed to continuously improve protocol for quality control and oversight. The results can be truly astounding: on average, Pharma Tech has been able to ‘close the book’ on quality control deviations twice as quickly since the inception of F.I.R.S.T.

Sign up for your free email newsletter

The key takeaway for CMOs is that precise quality is best achieved through a top-down, holistic structure that includes everyone, from the CEO down to the production floor, in the quality control process. For pharma and biopharma companies searching for a strategic partner, this commitment to quality can make all the difference.