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The concept of the Qualified Person is exclusive to the European Union and was first esta

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

blished 1975.

According to EU directives pharmaceutical companies must employ the servic

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

Examples of combination products may in

es of a MHRA/VMD accredited Qualified Person (QP) to adhere to the following applicable r

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

egulatory requirements.

 Good Manufacturing Practice (GMP) for medical products

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

(2003/94/EC)

 Good Manufacturing Practice (GMP) for veterinary medicinal pro

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

Combination pro

ducts (91/412/EEC)

 Good Clinical Practice (GCP) in conduct of clinical tria

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

ls (2001/20/EC)

 Community code relating to veterinary medicinal products (2

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

001/82/EC)

 Community code relating to medicinal products for human use (200

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

1/83/EC)

Companies that manufacture medicines and drugs for clinical trials can ofte

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

n find that increases in demand, new ventures or unexpected changes in personnel require

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

he services of a contract consultant QP.

The effects of a company not being able to rele

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

Following aspects would a

ase its product in to the market place as a result of not being able to meet the regulato

dd to the challenges in developing combination products:

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

ry requirements could mean disaster for the profits, market share and reputation of the c

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

ompany.

Organisations regularly use consultants to provide the final QP certification fo

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

r the finished product by either taking full responsibility for the manufacture, assembly

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

, packaging, labeling, storage, testing and distribution activities.

In some cases, cert

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

Professional from academic institutions, pharmaceutical industries, health care indust

ification may require extensive auditing of sites which can stretch the existing resource

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

s. In this situation many companies have found it prudent to use a consultant QP as a sma

.

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

rt solution to this problem.

This is becoming a more widely used and acceptable cost-eff

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

Companies that provide selfless information through particip

ective means of production and manufacture for companies without the appropriate QP cover

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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