Three Questions to Ask Your CMO about Standard Operating Procedures

Developing and implementing standard operating procedures (SOPs) are an important part of drug development and manufacturing. Done correctly, SOPs provide consistency and ensure that procedures meet FDA standards. Done poorly, they can be unclear, leading to errors and inconsistencies and focus on the how but not the why.  A challenge of enforcing quality SOPs is that information can become quickly outdated because of constantly updated FDA regulations.

Yet, failure to adhere to or properly utilize SOPs can have severe consequences in terms of 483 observation, warning letters, or worse fines.  The FDA defines an SOP as a written procedure that describes and details all necessary job tasks to ensure that drug products have the identity, strength, quality, and purity they claim to possess.

Implementing SOPs can be complex and complying with cGMP requirements can be even more difficult.  So when evaluating potential contract manufacturing organizations (CMOs), it is important to ask questions about their SOPs. As a prospective sponsor, here are three pressing questions to ask:

• Is the SOP suitable for its intended purpose? FDA rules can be open to interpretation, and different consultants may have different approaches and viewpoints.  Yet whatever is being proposed must meet the guidelines promulgated by the agency and meet the standards set by your consultant.  See how open and transparent the potential CMO is during your audit. That said, some SOPs are proprietary; so ask them how they plan to develop and approve new SOPs specific to your project.

• Can you collaborate with our consultant to help us reach our goals? It’s important that the CMO can collaborate closely with the consultant and sponsor to understand the sponsor’s plans.  The potential CMO partner must understand if you plan to license the intellectual property (IP) or to bring it to market. Sponsors that plan to sell their IP may not be as concerned with late-phase SOPs.

Look for CMOs that ask questions to better understand your situation, budget, resources and goals. A CMO that listens can make smarter recommendations. For example, if your company is looking to license your IP, you may need to use your money very efficiently, and decide not to go to the expense of commissioning procedures that are a nice to-do in the early stage but a must-do in a later stage. Conversely, if your company plans to take the drug through clinical trials and to market, you don’t want a CMO to tell you to postpone a procedure until a late stage, when the associated costs may increase significantly.

• How does your CMO develop new, manufacturing SOPs, especially if we’re pushing boundaries on the science? Beyond the hundreds of global SOPs that range from how to receive raw materials and set specifications to how to do an investigation and respond to customer issues, CMOs must be able to develop specific manufacturing SOPS, which provide step-by-step instructions to follow in each manufacturing process.

Ask what steps they follow to validate processes to ensure that you’re in GMP manufacturing compliance and that results are valid regardless of the outcomes.  They must demonstrate that even if the outcome isn’t what was hoped for, that it was not due to mistakes made in the manufacturing process.

It’s also important to ensure that SOPs are complete, consistent and openly shared not only for audit readiness, but also to ensure that  if the relationship ends, a secondary supplier can be brought in or even if someone is acquired , there’s an open playbook for everyone to follow.

Aside from FDA rules and internal SOPs, the underlying driver of SOP compliance is ensuring quality.  As the focus on quality continues to gain increasing focus, sponsors, their consultants and their agencies of choice must be on the same page in ensuring sound business models that drive the next generation of effective and safe drug delivery.

About the Author

Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.