Businesses are no longer isolated in today's global environment. Industry groups such as Rx-360, the international supply-chain
consortium, and regulators recognize this new environment and are now more than ever embracing partnerships aimed at sharing
information and harmonization initiatives. Our research shows that industry executives are relying less on internal stand-alone
initiatives and instead, are seeking out regulatory and industry best practices and standards (see Figure 6). To support these
initiatives, we recommend implementing the following approaches and systems.
Figure 6: Preferred drivers among industry executives for supply-chain management best practices. (Note: PhRMA is the Pharmaceutical
Research and Manufacturers of America; BIO is the Biotechnology Industry Organization.)
On-demand visibility. On-demand visibility is the ability to assess data and product information when you need it when someone else is storing and
managing it. On-demand strategies and systems provide the ability to obtain relevant information about the product at the
appropriate time to enable decisions with a high degree of confidence based on the analysis of contemporary data. On a day-to-day
basis, on-demand visibility enables authorized parties to "spot audit" suppliers by reviewing contemporaneous data and changes
potentially impacting product safety, efficacy, and quality. These real-time views into supplier or contract-provider activity
can complement periodic on-site audits of facilities. To get this level of visibility, companies should move away from paper
and spreadsheets and instead use information systems and technology. Interfacing internal systems such as ERP and QMS with
suppliers' operational and quality systems can provide a complete batch-history record of the products delivered, including
critical quality attributes (CQAs) and process parameters (CPPs). These interfaces also allow the sponsor company to take
full advantage of business intelligence, analytics, and planning software to bring together data residing in different systems
to control finished good quality and better adjust downstream processes.
Network control. Companies that outsource processes or source materials must take the view that their product's life cycle incorporates an
entire network, not just a thin chain. This perspective is crucial for total product control. A network approach requires
changing the mindset from one where brand owners pressure suppliers to "do it my way" at the lowest possible cost. Instead,
it calls for tighter collaboration and increased communication with all parties involved (e.g., suppliers, distributors, packagers,
contract service providers). These partners should be involved at the earliest stages of the product life cycle and should
be viewed as extensions of the brand owner.
With the reality of limited resources, companies should adopt risk-based supplier management strategies. This involves assessing
partners based on a total risk profile and the potential impact to the process, product, and patient. Adequate control often
requires deep process and product understanding as well. Therefore, companies should collaborate with their supply network
to gain deep understanding of and implementation of systems that provide visibility into process control based on CQAs and
CPPs. Process control is another area where technology can play a major role to promote the exchange of information to enable
partners to become an extension of the company's own facility, using standards-based and interoperable systems.
Collaboration. Industry and regulatory bodies must work to form new partnerships to manage this new industry complexity and its accompanying
costs. The use of cross-functional teams are a key to successful global supply networks as the interactions between pharmaceutical
companies as they shift from casual exchanges to long-term, stable relationships. To establish an open dialogue, brand owners
and their partners must clearly see the value the impact of their relationship. Key to this relationship is the opportunity
for the partner to challenge assumptions and work together with the brand owner toward improved solutions.
To succeed in today's global environment, collaboration strategies must also embrace reasonable and common-sense approaches
that can be broadly leveraged by all stakeholders. Increased collaboration requires changing the internal structure of companies
to better manage the cross-functional skills and staff used to support global supply chains. The focus should no longer be
seen as a purchasing exercise to save costs. A balanced team approach is necessary to minimize risk, maximize value, and ensure
product safety, efficacy, and quality.
Better collaboration also means that interactions with suppliers and contract providers needs to begin earlier in the process.
It means engaging suppliers who are willing to share information in real time and on demand because they understand it is
in the best interest of all stakeholders to do so.
Collaborative approaches such as these can: drive reduction of redundant, costly audits; create a transparency of relevant
information to ensure product safety; and help to develop measurable scorecards to aim at improving performance and mitigating