"How To Decide If Your Product Would Be Better Off At a Contract Manufacturer"

The strategic use of corporate resources is a topic receiving much attention these days. Many pharmaceutical companies are questioning the way things have been done in the past, and are seeking new justification for all procedures.

During this period of questioning, some shrewd companies are asking: "Would our organization's needs be better served if we did not manufacture our product ourselves?" The following checklist provides points to consider. A "yes" answer to any of these questions suggests that using the services of a contract manufacturer should be seriously considered.

1. Do you need specialized facilities?

Contract manufacturers usually specialize in a particular area, such as sterile or oral pharmaceuticals. Hence, they have diverse, specialized equipment available and ready to meet your needs. You may find it difficult to justify expensive capital improvements for a low volume or unproven product. A contract manufacturer can provide the proper facilities without your need to invest in bricks, mortar and validation.

2. Do you need help with specialized delivery systems?

There is probably a contract manufacturer who has already worked with such a system. If not, a contract manufacturer will usually have the time and space available to assist you in developing a specialized delivery system.

3. Are your facilities equipped to make small-scale batches?

Contract manufacturers usually are willing to make the small-scale batches required for development, validation or clinical supplies. Oftentimes these projects take a "back seat" to production work at major pharmaceutical companies, but they receive much greater attention at a contract manufacturer.

4. Can you easily break into your own production schedule to make clinical batches?

Contract manufacturers usually have no product lines of their own. Hence, they have more flexibility in the use of their facilities than you may have with yours.

5. Are you unsure of the market potential for your product?

Before investing in capital equipment to produce the product in-house, let a contract manufacturer supply your requirements until sales volume makes it advantageous to bring the product in-house.

6. Do you have sufficient manufacturing capacity?

Contract manufacturers can provide additional capacity to help you satisfy the changing needs of the marketplace.

7. Can your internal manufacturing capability offer fast turnaround?

Contract manufacturers have flexible manufacturing schedules that are more accommodating to "rush" projects.

8. Do you want to build, repair or remodel your own manufacturing facilities, yet you are concerned about being able to continue to supply the needs of the marketplace?

Contract manufacturers can supply your needs while your own capacity is not available.

9. Do you need a second source of supply?

Contract manufacturers function very well in this role because of their flexibility.

10. Do you need product and/or process development assistance?

Some contract manufacturers offer these services as well as assistance with analytical methods development and Regulatory Affairs.