A recent survey of top life sciences organizations found that compliance issues and increased industry consolidation (via mergers and acquisitions) are the top challenges faced by companies in today's market.
In the past 10 years ending December 2009, there were 1,345 mergers in the pharmaceutical industry with a total deal value of roughly $694 billion, according to a report from Levin Associates Inc., a health care intelligence service provider.
As a result of the consolidation in the industry, the need to achieve compliance with worldwide regulatory standards is a major issue for organizations trying to maintain their competitive edge in global life sciences industries.
Professionals in the pharmaceutical, biotech and medical device industry said that varying supply quality standards and differing mandates across countries or regions are the greatest obstacles to managing quality and compliance.
Moreover, increasingly global supply chains and greater industry consolidation are causing companies to re-evaluate their current practices and adapt to the changing industry landscape. Three-quarters of respondents said that they work with more than four global suppliers, with growing numbers of suppliers posing potentially significant threats to supply quality when not managed properly.
Key findings of the survey also included:
The status quo is not sufficient. More than a third of those surveyed said they believe their quality management systems are not adequate to manage supply chain risks and promote safety, indicating that the status quo is not enough to manage increasingly complex supply chain issues in a growing and changing market.
IT preparation is critical. Almost half of respondents reported that their companies are not equipped to manage IT consolidation resulting from mergers and acquisitions, with more than one quarter expecting that these activities would have a negative effect on product quality and safety. Without adequate IT preparation, companies run the risk of damaging their brands and endangering consumers.
Quality-related risk must be prioritized. Nearly one third of respondents do not categorize supplier relationships based on the risks they pose to the organization, exposing companies to undue vulnerability and potential product quality issues.
"As global authorities strengthen regulatory requirements, and mergers and acquisitions continue to dominate life sciences industry headlines, companies require comprehensive quality systems that can manage these complexities and alleviate risk," said Jon Nugent, Life Sciences Practice Manager at Business Intelligence Solutions Inc., a Massachusetts company providing Quality Management Software and Professional Services to pharmaceutical, biotech and medical device companies.
Quality systems and operations must be re-evaluated as the supply chain becomes increasingly global and regulatory scrutiny increases writes Jack Garvey, Esq., of Compliance Architects LLC.
In his most recent interview, Jack outlines areas and issues that create risk in this environment. For a copy of the interview, please email info@busintellsol.com and request FDA Inspection Readiness.
Below are a few tips Jack has shared previously on how companies can better prepare for the challenges ahead.
1) The most significant thing you can do is to have robust, well-designed, regularly reviewed quality systems. Your efforts should be laser-focused on having the best systems possible – that have been evaluated, reviewed and critiqued (and put through their paces) by experts in the field. No amount of inspection management finesse, charm with the Investigator, etc. will substitute for this important step.
2) You must meet more than the FDA’s stated regulations – you must meet the Agency’s expectations
3) Quality systems are only one part of the equation – you must be able to tell your “product control story” through a product quality plan tied to individual products or product families, as appropriate.
4) Focus on positioning “negative information” in the best light. Make sure your investigations are robust, and they are tied to the appropriate preventive actions, and if not, amend them with additional review information.
5) You must embrace advocacy in your preparations for FDA inspections.
6) Do not make the mistake that your relationship with an Investigator, or the Agency, will give you a pass – it won’t. And, if it does get you out of a jam, it will only serve to make you more complacent with respect to future inspections – and, those have a far greater likelihood of not going as well.