Tablets and capsules are common dosage forms, and many contract manufacturers offer oral solid dose services. But the general capability of a site listing does not show whether it can make a particular product, at the required scale and on the required schedule.
A site can list "oral solid dose" services and still be a poor fit for a particular product. Gaps may emerge during technology transfer, when validation batches are scheduled, or when a material shipment is delayed. At that stage, changing suppliers can take time and add cost.
Three questions that help to identify potential gaps early. They concern equipment, capacity, and the site's supply chain.
1 Does the site's equipment match the product?
The first question is whether the site can make your product, not tablets in general. A plain immediate-release tablet, a modified-release tablet and a highly potent compound each need different equipment and different handling.
An immediate-release tablet typically involves blending and compression and may also require coating. A modified-release tablet uses additional steps, such as functional coatings or matrix systems, to control how the drug is released. A highly potent compound may require containment measures to protect workers and prevent cross-contamination. Controlled substances may require additional security, storage and licensing, depending on the product and applicable regulations.
So, two sites can both list "tablets" and still be a poor fit for the same molecule. It helps to ask for the site's equipment list and check it against each step of your process; at the batch size you plan to run.
Testing is also an important part of a transfer. A range of tests may be needed to compare the product made at the new site with the reference product. Dissolution testing can show whether a change in materials or process has affected how the drug is released. If testing is outsourced, coordination and external laboratory schedules can add time. Ask which activities are performed on site, and which are outsourced, including analytical method transfer, release testing and stability studies.
2 Can the site commit to the capacity at the time you need it?
A site may have the right equipment and still be unable to use it for you when it matters. Capacity is a question of timing, not only of size.
For a generic launch, important manufacturing batches are usually needed well before the planned launch. Exhibit batches can support a regulatory filing. Process performance qualification (PPQ) batches are used to demonstrate that the commercial manufacturing process performs as intended. Scheduling them depends on earlier activities, which may include analytical method transfer, equipment qualification and engineering batches. If an earlier activity is delayed, the PPQ schedule may need to be moved, and a new production slot may not be available according to schedule.
The site must plan these batches alongside work for its other customers. Ask how it manages that schedule, how it handles forecast changes, and when capacity commitments become firm. Vague answers about future commitments, difficulty accommodating forecast changes, or repeated movement of planned dates are reasons to ask further questions. They may indicate that available capacity is constrained.
Ask who will lead the project and how technical and quality knowledge is maintained when staff change. Also clarify how the project team can escalate issues and communicate with site management.
3 How does the site manage its own supply chain?
The site's equipment is only useful if the required materials are available. For the active pharmaceutical ingredient (API), ask where it is sourced and how many sources are approved for the product in the regulatory filing.
Reliance on one API supplier or one supply route can expose a product to risks such as shipping delays, regulatory issues, trade measures or local disruption. A second qualified source may reduce some of these risks, but qualifying a new source can take time and may require regulatory action. The same planning applies to excipients and packaging components. Some specialist materials have a limited number of suppliers.
Questions worth asking:
- Where is the API sourced, and how many sources are approved for the product in the regulatory filing?
- How does the site track lead times for materials and packaging components, and when does that tracking begin?
- What safety stock does the site hold, and who is responsible for its cost?
- How has the site managed supply disruptions, such as supplier failure or a change in trade measures?
Location can affect shipping times and logistics. However, location alone does not establish supply-chain resilience or simplify regulatory review. Ask how the site qualifies suppliers, monitors lead times, manages inventory and responds to disruption.
Company example: UPM Pharmaceuticals
The following is an example that illustrates how a company can successfully take into consideration of the three aspects discussed. UPM is a privately-owned contract manufacturer with a site in Bristol, Tennessee, United States. The company manufactures oral solid dose products, including tablets and capsules. It is a company that has been privately-owned for more than 25 years. More than 15 product families have reached the market through the site. UPM focuses on late-stage and commercial manufacturing, including technology transfer and scale-up.
| Capacity or Facility Measure | Area or Quantity |
|---|---|
| Manufacturing facility | 450,000 sq ft |
| Controlled-substance vault | 3,500 sq ft |
| Annual tablet capacity | 3.5 billion |
| Annual capsule capacity | 2.1 billion |
For equipment and handling, UPM manufactures coated and sustained-release tablets, hormones, and controlled substances in Drug Enforcement Administration (DEA) Schedules II to V. The company has analytical development, stability testing and microbiology testing available on site.
In its published guidance, UPM emphasizes early project planning, including risk assessment, knowledge transfer and tracking material lead times. The company also identifies capacity communication, staff continuity and access to the site as considerations when assessing a manufacturing partner. Hence, buyers can use UPM as a reference, how its considerations can be a model for questions for any prospective sites.
UPM clearly specifies its warehouse capacity and vault space, as well as its packaging, serialization and aggregation services at the site. For a product intended for the US market, domestic manufacturing facilitates the planning of the transport routes and logistics. along with the site's inventory and disruption plans. Needless to say, even with the best capacity and manufacturing equipment, buyers still should confirm the source and filing status of the API and other materials for their product.
Putting the questions to work
The questions discussed can help to identify gaps before a shortlist is finalized. Check whether the site's equipment matches the process, whether it can commit to the required dates, and whether the material supply plan is robust. They are a starting point for due diligence, alongside review of the site's quality systems, regulatory history and product-specific experience.
Note
Information concerning UPM facilities is available on their website or on cdmohub.ai where UPM is a founding partner member.