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I have spent many years in purchasing or a production arena which required outsourcing at times. I have outsourced printing, duplicating, and microfilming, as well as outsourcing a Copy Center of a large pharmaceutical firm. I will share my thoughts on ho

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

w to create a successful outsource relationship with a vendor.

1. Before you outsource, make certain that the department having the need has the backing of upper management. Purchasing, finance, legal department (if you have one), in addition to the depar

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ment needing the assistance should be involved.

2. Discover exactly why you need to outsource. This will help you determine what you may need to do for future plant improvements and staffing. Example: You are going to outsource because you do not have eno

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

gh plant capacity to produce the item; or, you do not have adequately trained staff to produce it; or, it may be more cost effective to produce it at a vendor.

3. With the assistance of Human Resources, Finance, Accounting, and the department in need, det

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

rmine ALL the costs of producing the item in house: Man hours, electrical requirements, water, heating and cooling, labor costs, machine cost/hour etc. Once you know what your costs are, now you can begin to locate qualified vendors.

4. I have always empl

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

yed a team of people who had a stake in the proposed outsourcing program. In one Company, the team was comprised of the Marketing, Legal, Purchasing and Administrative Services. The outsourcing project was to determine whether it was cost effective to brin

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

in a vendor to supply the firm with in plant copying.

5. Once you have chosen at least three suppliers, based upon quality, capability, testimonials of some of their customers, and viewing some of their operations, you can progress to the SOW (Statement

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

f Work).

6. The SOW MUST contain all of the elements or tasks that will be performed by the outsourced party.

7.. The Request for Proposal will contain such items as: defining the hours of operation, who authorizes the overtime if it is needed, who does

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

he outsourced group report to, which Company has the right to hire or fire, the length of the contract, the anticipated production numbers to be produced, whether the vendor will be permitted to subcontract some of the production work etc.

8. Once the RFP

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

has been prepared, a letter and a RFQ (Request for Quote) should be prepared inviting the selected suppliers to bid on the proposal, Each supplier MUST receive the exact same proposal with no variations. Give the proposed vendors an exact date as to when t

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

e RFQ must be returned. Emphasize that the RFQ must be signed off by a Corporate official and not a salesman. No vendor should receive a time extension unless they all receive it.

9. When the RFQs are returned, a spreadsheet can be prepared to compare cos

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ts. Where necessary, written verbage can be used to demonstrate added commitments that the particular vendor will include in his costs. For example a vendor may include pick-up and delivery to every organization at no additional charge. This spreadsheet is

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

extremely important because you will want to use it to prepare a Powerpoint Presentation for upper management when presenting your proposed project for final buy off.

10. Once you have selected the winning bidder (it does not always have to be based upon

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ost) it is extremely important to sit down with the supplier and the department(s) the supplier will be servicing and establish EXPECTATIONS. For an example of expectations I will return to my example involving the Copy Center I (with my comrades) establis

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ed at a major pharmaceutical firm. We devised the following quality grade card that accompanied EVERY project that left the copy center, no matter how small or large. On this card, the following information was requested: Timeliness, Quality of reproductio

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

, Staff responsiveness, Staff helpfulness, Followed instructions. Each of those items were rated on a scale of 1-10 (10 being best). There was also room for additional comments. The project originator was then asked to send the QC card back to the copy cen

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

er so that it could be reviewed as to what went right and what went wrong. As an incentive for people to return these QC cards, we would randomly select one card at the end of the month and the party who was selected would receive a FREE lunch in one of th

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

Company cafeterias. You may be thinking about how this system worked out. Very well, if I say so myself. The first year, the vendor was operating at a 97.7 average rating. I will also state that these QC ratings became a very high source of pride to the s

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

pplier and its employees. They even asked permission to promote their successes to other possible clients.

This is not meant to be a comprehensive dissertation on outsourcing, but I hope that it will assist anyone who is at the point of having to have the

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

services performed outside or by a service group inside. Also, this outline for outsourcing can be applied to any services needed, such as maintenance, landscaping, printing, custodial work, cafeteria staffing, etc.

Until next time.

Charles "Jitiy" Vaugh

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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