"How To Decide Which Contract Manufacturer Is Best For You"

Once you have reached a decision to utilize the services of a contract manufacturer, how do you identify one that meets your needs?

If you are fortunate, you may have already established a relationship with a contract manufacturer with the capability to perform the required task. If not, you should begin your search by seeking the advice of your colleagues in the industry. There is nothing better than a personal recommendation from someone who has successfully used the services of a particular contract manufacturer. Learn how that manufacturer has lived up to mutually agreed upon requirements. Finally, ask how the personnel of that manufacturer interrelate with customers and how well qualified are the personnel assigned to projects.

Your next source of information is trade journals. Contract manufacturers generally advertise their services in those journals having the widest circulation within the industry. These journals usually print an annual Buyers Guide in which their advertisers are grouped according to the services they provide. By searching through these journals and Buyers Guides you should be able to identify one or more contract manufacturers that have the capabilities you require.

Once a list of potential contract manufacturers has been assembled, evaluate each according to the following checklist.

1. Does the contractor provide manufacturing facilities that conform tocurrent Good Manufacturing Practicesas established by the U.S. FDA?

2. Will the contractor allow the customer to inspect the contractor's facilities and procedures?

3. Will the contractor allow the customer to audit the manufacture of every batch of customer's product?

4. Will the contractor provide a Letter of Access to the contractor's Drug Master File at customer's request?

5. Will the contractor submit to customers a protocol of analysis listing results of testing for each lot of product shipped, upon shipment, as well as completed batch records?

6. Will the contractor be responsible for the loss of raw material, due to its own negligence or failure to perform according to mutually agreed upon standards or obligations?

7. Does the contractor require the customer to complete a Product Questionnaire before work? Such a questionnaire provides information to permit the contractor to evaluate your project or product completely.

8. Is the contractor willing to furnish the customer with a list of minimum requirements that the contractor expects from the customer?

9. Does the contractor insist that both parties, contractor and customer, mutually agree upon the requirements expected of each before work is initiated?

10. Does the contractor provide all the services you need?

A. Formulation Development?
B. Process Development?
C. Capability and experience with a particular specialized
dosage form of interest to you?
D. Manufacturing capability needed?
E. Testing Laboratories?
F. Document Revisions?
G. Certificates of Analysis?
H. Distribution Capability?
I. Regulatory Assistance?

11. Does the contractor have a satisfactory relationship with Regulatory Authorities? Are the results of inspections, and the response to inspection reports readily available to the customer? (For example, in the United States, are FD483's available from the contractor?)

12. Do the contractor's responses to Regulatory Authorities indicate a willingness to cooperate or a tendency toward combativeness?

13. Is the contractor willing, and able, to enter into long-term Supply Agreements?

14. Does the contractor require that the customer review and approve master batch records before their use?

15. Does the contractor require that the customer either have its representative on site during manufacturing, or have a knowledgeable person on call to provide immediate response to questions that arise during manufacturing?

16. Does the contractor have the capability, facilities and capacity to manufacture both your clinical products and your production batches? (So you don't have to obtain approval for another manufacturer.)

17. Is the contractor willing to work out a satisfactory match with your timetable?

18. Does the contractor have the facilities and staff to offer you flexibility in formulation, manufacturing, quality assurance, labeling and packaging?

19. Does the contractor offer analytical support? Is it adequate for your needs?

20. If needed, is the contractor able to offer "turn-key" services, e.g. develop, manufacture, control and distribute your product?

21. Does the contractor offer Confidentiality Agreements?

22. Is the contractor an Equal Opportunity Employer?

23. Has the contractor had experience with supplying materials for government contracts? Such experience will assure that the contractor can help you remain in compliance with special government requirements.

24. Are there any products produced by the contractor that are sold internationally? Knowledge of intricate export and foreign regulatory requirements will be valuable if you plan to sell overseas.

25. Does the company have an established process to continually improve quality?

26. Does the contractor encourage innovation rather than maintaining the status quo? What examples of new practices, procedures, etc. can it point out?

27. Does the contractor have a Customer Services Department which is responsive to your inquiries?

28. If you are seeking a contract manufacturer for a sterile pharmaceutical product, does the contract manufacturer have the capability and capacity for:

A. Clean, nonaseptic processing? (Requires terminal sterilization)
B. Aseptic processing?
C. Lyophilization?
D. Terminal Sterilization? (required wherever applicable)
E. Development?

1. Formulation?
2. Lyophilization cycle?
3. Sterilization cycle?
4. Unique dosage forms?
5. Emulsions?
6. Suspensions?
7. Container/closure compatibility?
8. Pyrogen testing?
9. Sterility testing?

F. Validation?
G. Quality Assurance?
H. Inspection?
I. Labeling?
J. Packaging?
K. Distribution?
L. Regulatory Assistance?
M. Stability Studies?

29. Is the contractor selling excess capacity of its parent company? What assurance do you have that there will be no conflict between producing your product and the parent company's?

Examine your responses, Yes or No, to each of the above interrogatories for each potential contract manufacturer you have identified. More than likely, only one will offer the services which you require.

For more information concerning the services offered by Ben Venue Laboratories, contact our Customer Services Department at (440)232-3320, Ext. 224, or request information by FAX to (440)439-6398, Attn: Customer Services Department. We shall be pleased to send you a copy of our company brochure, product questionnaires, confidentiality agreement, customer services reference cards, or any other information you may require.

Ben Venue Laboratories is the oldest and largest contract manufacturer of sterile pharmaceuticals in the United States. Although we are best known for our expertise in lyophilized parenterals, we are also a major developer and manufacturer of liquid injectables, sterile ophthalmics, sterile topicals, materials for sterile in-vivo devices and sterile diagnostics.