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Picture the scene, its Monday morning and you’ve traversed the morning rush hour and arrived at the office only to find a disaster zone. Over the weekend the office has experien

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

ced a fire that has all but destroyed the premises. IT, key documents, plant and machinery – gone – what are you going to do?

Ok so this may be an extreme example but it happen

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

Examples of combination products may in

s. Disasters and accidents happen every day and affect many businesses some of which fail to recover – don’t put yourself in this situation.

For many businesses and their mana

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

gers disaster recovery planning never cross their minds, businesses carry out their usual day to day activity unaware of what could happen if disaster struck, but there are some

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

fundamentals that you should consider. The first of which is a disaster recover plan.

The disaster recovery plan should describe how your business will cope in the case of an e

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

Combination pro

mergency, what actions will be undertaken and who will co-ordinate them. But what things should go into a plan? In our checklist below we describe some of the things to conside

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

r.

Disaster Recovery Checklist.

1. Analyze your business

What systems can be down for what period of time before serious consequences occur. For example if yo

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

ur ERP system goes down and you can’t process sales what’s the impact? With a subjective view you’ll probably find that you can manage without some systems for a while (perhaps

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

upto a week) with other’s you’ll need them back up again as soon as possible. Develop some computer failure procedures to manage your key business activity when IT is unavailabl

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

e – make sure that copies of these processes are included in the plan.

2. Identify possible risks

Examples of risks to your business include the loss of IT systems, lo

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

ss of buildings or plant/machinery etc. Detail some mitigation in your recovery plan. For example if you don’t have access to your office in the event of a disaster is there ot

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

Following aspects would a

her business premises/temporary accommodation that you can use? If so list appropriate telephone numbers as part of the plan.

3. Recovery team

Put together a recovery

dd to the challenges in developing combination products:

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

team with clear lines of authorization who are responsible for co-ordinating activity in case of disaster. They should be responsible for maintaining your disaster recovery plan

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

and meet on a regular basis to ensure that the plan is still relevant and accurate.

4. Backup your IT systems

Ensure that you backup your IT systems at suitably regular

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

intervals (and test the recovery process!!!) Make sure that any backup tapes/CD’s are stored off site or in a fire proof safe. Make sure the recovery process is documented in

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

your Disaster recovery plan.

5. Inventory your key equipment

Keep an inventory of crucial capital equipment and machinery so that it’s easily identified and replaceable

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

Professional from academic institutions, pharmaceutical industries, health care indust

if needs arise. Keep a record of suitable suppliers and contact numbers so that you can use them in an emergency.

6. Identify any external risks

For example if a busine

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

ss partner (perhaps a key supplier?) suffers a disaster what is the impact on your business and how would you mitigate it?

7. Don’t forget the paper

Too many businesse

.

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

s focus their disaster recovery plans purely on IT – don’t forget the impact a loss of paper records may have. How would you manage if all your paper documents are destroyed.

A

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

Companies that provide selfless information through particip

bove all else think about it! – Accidents and emergencies do happen but providing you plan for it and have suitable back up plans and arrangements you’re business need not suffer

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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