CDMO Site Visit Checklist: What to Review Before Selecting a Partner

A polished capabilities presentation can tell you what a CDMO says it can do.

A site visit helps you understand what the operation actually looks like.

You can see the proposed manufacturing environment, meet technical and project teams, ask how work moves through the facility, and investigate the assumptions that put the CDMO on your shortlist in the first place.

That makes the site visit more useful when it is treated as part of the selection process rather than a facility tour.

The goal is not to count stainless-steel tanks or admire cleanrooms.

The goal is to come away with a clearer answer to:

Does this facility appear capable of supporting our program, and what still needs to be verified?

This distinction matters.

A sourcing or technical site visit may help a sponsor understand:

• facility fit
• manufacturing operations
• equipment
• project-team structure
• development support
• technology-transfer expectations
• capacity
• communication style

A formal supplier or quality audit is a different process and may require qualified quality personnel, formal documentation, audit procedures, and sponsor-specific qualification requirements.

A site visit is much more productive when the sponsor arrives with specific questions.

Before traveling, review the information already collected about the CDMO.

That may include:

• proposed facility
• manufacturing capabilities
• equipment
• batch size
• project scope
• regulatory history
• development services
• timeline
• proposal assumptions

Then identify the issues that still need clarification.

If the CDMO is on the shortlist because it appears to have a particular manufacturing capability, make sure the visit actually investigates that capability.

Large CDMOs may operate many sites.

Do not assume the facility you are visiting is necessarily the facility that would perform all of the work.

Ask:

Which activities would happen here?

Would any part of the program move to another site?

Where would analytical testing occur?

Where would drug substance or drug product be manufactured?

Would any work be outsourced?

Understanding the physical manufacturing chain helps prevent surprises later.

Try to understand how material would move through the facility.

You do not need to become a manufacturing engineer during the visit.

You do want to understand whether the flow appears logical for the proposed project.

Depending on the modality, this may involve looking at:

• material receipt
• storage
• staging
• manufacturing suites
• sampling
• analytical testing
• intermediate storage
• finished product handling

Ask the CDMO to explain how your program would move through the site rather than giving only a generic facility tour.

A company may own impressive equipment that has nothing to do with your program.

The useful question is:

What equipment would be used for our process?

Where appropriate, ask about:

• size
• configuration
• practical batch range
• availability
• dedicated vs. shared use
• cleaning or changeover
• equipment differences from the sponsor's current process

If a technology transfer is expected, equipment compatibility can be especially important.

The answer can reveal whether the CDMO's operating model fits your company.

An emerging biotech may need:

• more development support
• more frequent technical interaction
• flexibility around an evolving process
• smaller manufacturing campaigns

A mature pharmaceutical company may have a different expectation.

Ask what projects similar to yours typically look like at the facility.

You are trying to understand whether your program would fit naturally into the organization's normal way of working.

One of the most useful parts of a site visit is often not the facility.

It is the people.

Try to meet representatives from the functions that would materially affect the program, where appropriate.

That may include:

• project management
• process development
• manufacturing
• analytical development
• quality
• supply chain
• technology transfer

A strong business-development presentation is not the same thing as a strong project team.

Ask who would actually own the relationship after the contract is signed.

Manufacturing relationships generate questions, changes, decisions, and occasionally problems.

Ask how those situations are handled.

Useful questions include:

• Who is the main point of contact?
• How often are project meetings held?
• Who makes technical decisions?
• How are issues escalated?
• Who approves changes?
• How quickly are sponsors notified of problems?
• What information will the sponsor receive routinely?

Clear governance can make a complicated manufacturing relationship much easier to manage.

If your process is moving into the facility, ask the technical team how they would approach the transfer.

Questions may include:

• What documents are required?
• What process knowledge is needed?
• What equipment differences exist?
• What analytical methods must transfer?
• What development work is expected?
• Would an engineering run be recommended?
• What does the sponsor need to provide?

The quality of this discussion can tell you much more than a generic statement that the CDMO “supports tech transfer.”

If the process is not fully mature, investigate the development environment as closely as the manufacturing area.

Ask:

• What development work can be performed internally?
• Which scientists would support the program?
• How does development hand off to manufacturing?
• Are development and GMP teams at the same site?
• What happens when a process does not transfer cleanly?

For early programs, this can be one of the most important differences between CDMOs.

Find out where analytical work will happen.

Some CDMOs perform extensive testing internally.

Others use external laboratories for certain methods.

Ask:

• Which methods are in-house?
• Which are outsourced?
• Who manages external testing?
• What are typical analytical lead times?
• How are unexpected results investigated?
• How are methods transferred?

Analytical timelines can become part of the critical path.

Capacity should be discussed specifically.

Ask:

• When could the project realistically start?
• When could development work begin?
• When could technology transfer begin?
• When is the first realistic manufacturing slot?
• What equipment is actually available?
• How is the slot reserved?
• What happens if the schedule slips?

A facility may have capacity in general while the equipment your process requires is fully booked.

Manufacturing depends on materials arriving at the right time.

Ask who is responsible for:

• raw materials
• components
• specialized reagents
• starting materials
• containers and closures
• long-lead items

The CDMO may manage some of these while expecting the sponsor to manage others.

Clarifying responsibilities early can prevent schedule problems.

This is partly subjective, but still useful.

Pay attention to whether the people you meet seem to understand your project.

Do technical and commercial teams appear aligned?

Can people answer operational questions clearly?

Do answers remain consistent as you move between departments?

A site visit can reveal organizational friction that will never appear in a marketing deck.

One awkward answer should not determine the decision.

Patterns are more meaningful.

If preliminary diligence surfaced facility-specific regulatory history, the site visit may be an opportunity to ask for context.

That could include relevant FDA Form 483 observations or other facility history.

Approach the discussion as diligence rather than accusation.

Useful questions may include:

• What corrective actions were implemented?
• Has the relevant system changed?
• Has the facility been inspected since?
• Is the observation relevant to the proposed manufacturing area?

Formal regulatory and quality conclusions should still be made by qualified sponsor personnel.

This is one of the better questions a sponsor can ask.

Instead of only asking why the CDMO is a good fit, ask the technical team:

What do you see as the biggest risks in transferring and manufacturing this program here?

A thoughtful answer can reveal:

• process risk
• timeline risk
• analytical gaps
• equipment limitations
• material dependencies
• development work still required

A manufacturer willing to talk about uncertainty can be more useful than one that treats every project as straightforward.

Do not rely on everyone's general impression of whether the visit “went well.”

Capture the findings while they are fresh.

Separate them into:

Confirmed strengths

Remaining questions

Potential risks

Items requiring formal verification

Then compare those findings against the same criteria used for the other CDMOs on the shortlist.

That keeps a charismatic site visit from accidentally outweighing the actual manufacturing requirements.

Pharma Connect Navigator helps sponsors narrow the CDMO market before deeper diligence begins.

Sponsors can define their manufacturing requirements, identify potentially relevant companies and facilities, compare project fit, and investigate available information about capabilities, equipment, scale, and regulatory context.

That helps teams decide which manufacturing partners are worth spending the time and resources to investigate more deeply.

PCN does not perform sponsor audits or formally qualify vendors.

It supports the sourcing and preliminary diligence work that can help sponsors reach those later stages with a better-qualified shortlist.