Improving Collaboration in the Pharmaceutical Industry Between Sponsor Companies and CMOs
Current regulatory guidelines for the pharmaceutical industry are growing more stringent than ever, with strict adherence to quality standards taking top priority. Furthermore, the increased scrutiny shows no signs of lessening anytime soon. In recent years, the FDA has trended toward issuing more warning letters to life sciences facilities and even has plans to collect quality metrics data for its own monitoring and inspection purposes.
In the current environment, life sciences firms have no choice but to remain vigilant about their quality processes. This aim is further complicated by today’s marketplace, where it is common practice for companies to work with contract manufacturing organizations (CMOs). As a result, sponsor companies must manage both the quality processes within their own facilities as well as any CMOs with which they form partnerships.
Poor Collaboration in the Pharmaceutical Industry Can Lead to Delays
Ensuring that good manufacturing practices are followed at CMOs is in the sponsor firm’s best interest. Over the past few years, the FDA has made it clear via several warning letters that it believes the sponsor company is responsible for the CMO’s compliance with any quality requirements.1 Deficiencies observed at contract manufacturing facilities could even impact plans for product launches. For example, a pharmaceutical company recently received a warning letter from the FDA for quality issues discovered at the CMO responsible for manufacturing a drug they’d hoped to launch.2
Such CRLs have the unfortunate effect of causing launch delays. In best case scenarios, the issues can be resolved within two to six months. The affected sponsor firm will still experience a delay but thankfully not an extended one. At the opposite end of the spectrum, the drug release can be pushed back for years depending on how long it takes to address deficiencies in the CMO’s facilities. The longer it takes for a drug to be released, the higher the risk of the company losing its market advantage.
CMOs cannot shoulder all of the time during these situations either. Often times, Form 483s can come as a surprise—being the first citation a facility may receive after years of successful inspections and product approvals. But if a CMO continually receives warning letters,3 then the sponsor firm needs to be aware of these discrepancies and ascertain why they persist. How can they promise a high quality product if the facility responsible for manufacturing it has exhibited lapses? The FDA observations could be more general in nature, but how can a sponsor guarantee that those deviations don’t extend to their product?
Sponsor Companies and CMOs Must Foster Collaboration in the Pharmaceutical Industry
These types of situations can be avoided if sponsor firms and CMOs could boost collaboration in the pharmaceutical industry. With the FDA holding sponsors responsible for lapses in their CMOs, companies cannot claim ignorance of poor quality management protocols. Instead, they must make sure that both parties maintain uniform levels of quality and compliance throughout the entire process. Sponsors must communicate acceptable quality standards to the CMO, and the CMO must share quality and compliance data with the sponsor to confirm that these expectations are being met.
Unfortunately, the tools that sponsor firms and CMOs use to collect, analyze, and share data may be outdated. They might rely on a spreadsheet that can propagate human-introduced errors. They might use disjointed systems that make sharing information difficult and unwieldy. They might even choose to transfer data via methods that are not secure and prone to bottlenecks. To avoid these pitfalls, sponsor firms and CMOs must make use of the latest available technologies that can facilitate transparency and collaboration in the pharmaceutical industry. As regulatory oversight increases, ensuring that quality standards between sponsors and CMOs are understood and uniformly followed will be paramount for success.
BIOVIA specializes in developing tools that support the aims of life sciences organizations. As today’s marketplace encourages the formation of strategic relationships between sponsor companies and CMOs, our platforms help foster collaboration in the pharmaceutical industry by providing secure methods to share important quality process data and related information. If you are interested in learning more, then please register for our event on Tuesday, April 26, where we will discuss why it is so crucial to improve data transparency between sponsor companies and CMOs.
- “Auditing Your Contract Manufacturers: A Regulatory Imperative,” June 13, 2014, http://www.naturalproductsinsider.com/articles/2014/06/auditing-your-contract-manufacturers-a-regulatory.aspx ↩
- “Product Quality Responsibilities Shared Between CMOs and Sponsor Firms Under FDA Scrutiny,” March 28, 2016, http://www.ipqpubs.com/cmo-story/ ↩
- “Burlington Re-inspection Earns AMRI New US FDA Form 483,” July 23, 2013, http://www.outsourcing-pharma.com/Contract-Manufacturing/Burlington-Re-inspection-Earns-AMRI-New-US-FDA-Form-483 ↩