For those of you keeping your eye on regulatory matters, 2013 has the potential to be a big year as the FDA gears up to release new guidance on a broad range of topics. Much of the forthcoming guidance is expected to target the regulatory aspects of contract manufacturing, namely Quality Agreements between the CMO and the pharma company customer.
The bottom line for contract manufacturers? Be prepared for frequent and meticulous regulatory audits, and more stringent documentation requirements. This comes as no surprise to CMOs – in recent years, regulatory inspections have become more frequent and involved.
Understand Your CMO’s Regulatory History
With regulatory hurdles – and costs – rising, it’s important to thoroughly evaluate your CMO or supplier’s operating and regulatory history.
Understanding how a CMO approaches regulatory matters is crucial to your company’s – and your drug candidate’s – success. Many contract manufacturers that serve customers worldwide encounter a myriad of regulatory requirements, including: DMF filings, ISO certifications, GDUFA legislation, Environment, Health, and Safety regulations and certifications, inspections from agencies around the world, and much more.
When it comes to regulatory matters, a supplier’s track record is the best indicator of their future performance.
Your CMO Needs a Strong Regulatory Department
Your CMO should possess a forward-thinking regulatory department that strives to stay in front of the latest technologies and trends. Learn whether your CMO:
- invests in facilities, technology, people and new products
- has a presence in your market, and is routinely inspected by that market’s regulatory body (e.g., the FDA in the United States market)
- supports customers with complete documentation, including Drug Master Files for their dosage form applications or ANDA filings
- has built a team that maintains a clear understanding of the possible direction of regulations and standards, and their potential impact on current or future products
- knows how to construct a strong Quality Agreement, with clearly-defined responsibilities and uncomplicated lines of communications between the Company and the supplier
Successful regulatory programs generally aren’t siloed – they exist across the organization and involve multiple departments, from QA/QC, compliance and regulatory affairs to supply chain & logistics, IT, operations and manufacturing.
Plan for Tomorrow
A common mistake in the months-long rush to negotiate and assemble a supplier contract is to minimize the importance of future regulatory and quality compliance…especially as a candidate moves from clinical development to larger-scale manufacturing. If your contract manufacturer can’t grow with you into various new markets due to regulatory limitations, then what’s your plan? As standards and regulatory requirements become more stringent, will your suppliers be able to keep up or will they drop markets they deem too expensive or burdensome?
There is a great deal of uncertainty in drug development: a particular compound may have unintended side effects or perform under par; regulatory approval may be delayed or withheld; a competing candidate may reach market first; funding might run out due to delays. Just think: a key supplier – having received an FDA warning letter (and perhaps struggling to manage the outcome) – has the potential to negatively impact your company and products several continents away.
With all of the inherent risks we face in the life sciences field, it’s crucial to your company’s success that you evaluate your supplier and assess their ability to handle the regulatory aspects of your product across the breadth of its lifecycle.
Let us know – What is the biggest regulatory hurdle for your company when selecting a CMO?
About the Author
Saharsh Davuluri is the President of Contract Manufacturing at Neuland Laboratories, Ltd., an API and Contract Research & Manufacturing provider based in Hyderabad, India. Neuland provides products and services to life sciences companies worldwide. With 45 U.S. DMFs, 15 Canadian DMFs, 9 DMFs in Australia, 363 DMFs in various European and other regulatory markets and 14 CEPs, Neuland has an unrelenting commitment to quality. The Company has never received a warning letter from any of the regulatory agencies who have routinely inspected Neuland’s facilities since operations began nearly 30 years ago.