Getting The Most From Your GMP Supplier Audit

Guest Blogger: Greg Weilersbacher
Founder & President, Eastlake Quality Consulting

All companies outsource. It’s a humbling fact that you simply can’t do it all yourself. This often has to do with resource allocation; your company may allocate dollars to build and sustain some activities in-house while choosing to contract higher-cost operations to qualified suppliers who already have the expertise and equipment. 

You may outsource the manufacturing of tablets, sterile injectable, or topical dosage form, or the GMP release and stability testing of your product. Once the production and testing is complete, the product may need to be stored under controlled temperature and humidity conditions and then distributed to locations around the globe. The Contract Development and Management Organizations (CDMOs) who execute these critical operations are of paramount importance to your company’s success. Choosing the right suppliers will also help to minimize stress-induced headaches throughout your organization. Here are the top five ways to get the most out of a supplier audit.

Coping with Scoping Your CSV/Part 11 Audit

You know you need a computer systems audit, but that’s literally the extent of what you know.
Has this ever been you?

Yes, you use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply. Terms like “cloud computing” make you feel slightly queasy. You’d rather get a root canal than discuss “distributed processing.” Your expertise is in manufacturing. Or clinical research. Or non-clinical lab operations. And somehow it’s your job to make sure an effective and properly-sized system audit is conducted. Great.

Optimizing Outsourcing Options for Small Sponsors

What can small sponsors do to secure the outsourcing resources they need as large CROs form strategic alliances with Big Pharma?

Partenships between large pharmaceutical companies and large CROs have become the norm.  The advantages for sponsor companies include shared risk, knowledge transfer, dedicated resources, shorter time to market, and the ability to implement the massive data integration that clinical development requires.  Strategic alliances are arguably as advantageous for their outsourcing partners, providing a steady pipeline of work that’s larger in scope and longer in duration than is typical under traditional arrangements.

Anatomy of a Vendor Qualification Program

Pharmaceutical companies are only as compliant as their vendors.  In a contract manufacturing arrangement, the manufacturer is held responsible for any cGMP deficiencies; however, you, as the sponsor or CRO, would be held responsible for your lack of vendor oversight.  Moreover, if your manufacturer fails to meet regulatory standards, you could lose millions in profits and patent exclusivity, damage your company’s reputation, and even jeopardize your entire business.

And that’s why a vendor qualification program is so critical.

Strategic Partnerships in Big Pharma: Implications for Small and Mid-sized Sponsors

Traditionally, large biopharmaceutical companies have outsourced clinical study responsibilities to a wide variety of external vendors, distributing the work across many service providers.  For their part, large CROs have routinely provided services to both large and small biopharmaceutical companies to keep their top-notch resources utilized to capacity and add to their bottom line.

Over the past several years, large sponsors and CROs have been trading in these transactional, fee-for-service business relationships for longer-term, tightly-integrated strategic partnerships.  And the trend is only accelerating.