Balancing Growth with Quality
The pharmaceutical contract development and manufacturing market is expanding at an astounding rate, yet there is not enough conversation about how contract development and manufacturing organizations (CDMOs) can conserve quality as they grow. Three major factors in balancing growth with quality include strictly adhering to a process, prioritizing professional growth at all levels of the organization and advancing technical capabilities.
Process validation is crucial.
It is how CDMOs develop a repeatable process for delivering reliable products and where lasting relationships are forged between CDMOs and sponsors. It is essential for both sides to maintain a firm understanding of what is expected of them and the part they play at each stage of the process, from process design through continued process verification. After all, both the rewards and the risks increase when reputations become one.
Quality must remain consistent.
As CDMOs grow, through consolidation or expansion, the stakes naturally raise along with heightened scrutiny, and it is pivotal to reassure pharmaceutical partners that the quality of products will remain consistent. For merging CDMOs, it could mean adopting one set of SOPs over another, and for expanding organizations, it should mean keeping electronic systems as close to the same as possible while preserving their commitment to training programs that work.
Invest in technical expertise.
Finally, to transfer productivity and precision into a sustainable work product, complementary investments in technical competency will be necessary. For CDMOs operating in the parenteral space, there will likely be additional expenditures as isolator technology has quickly become a prerequisite. Those that purchase newer isolators will benefit from the improvements in VHP technology that allow for faster line turnover, which is critical with multiple client products. Despite the high price tag that this equipment carries, the safety and sterility assurances that the technology brings are indispensable benefits.
At Grand River Aseptic Manufacturing (GRAM), we prioritize the quality of our product and invest heavily in the employees and technology that ensure its safety and reliability. We train all of our employees to bring the highest-level of quality to every aspect of their work. And while there are many ways to measure success in this area, for us, the most important metric has always been quality.
Learn more about balancing growth with quality in Contract Pharma’s January/February issue.
