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Digital images stored on computer servers is currently the low-cost solution for storing documents. However, that has not always been the case. For decades, microfilm was the

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

storage media of choice. Today many companies still have large libraries of microfilm.

Over the years, many different types of microfilm have been used to store records.

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

Examples of combination products may in

Roll Film - Documents are stored on 16 mm rolls.

- Microfiche - 7 rows of 14 images per sheet of film about 4 by 6 inches.

- Jacket microfiche - Simil

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

ar to microfiche but the strips representing all the pages of one document are placed in a special transparent "jacket."

- Computer output microfilm (COM) - Captures

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

omputer output directly on film.

- Engineering drawings - are normally recorded on larger 35 mm roll microfilm. Each "blueprint" is then cut off the roll and glued in

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

Combination pro

to a frame.

Issues surrounding use of microfilm

Lifespan Microfilm has a long life expectancy but it must be kept in temperature and humidity controlled envi

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

onment and left in special sealed containers. Only working copies should be used for retrieval purposes. No more than five working copies should be made from the master copy

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

. Additional working copies should be made from a working copy.

Some companies keep their masters in an air-conditioned room, but few businesses follow all the requirements

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

for a long life expectancy. Many companies don't even keep their master copies in a controlled environment at all more frequently the only original is used as the working cop

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

y. These errors in usage make the lifespan of microfilm much shorter.

Working copies Only working copies of roll film should be used in viewers or reader/printers.

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

he original is viewed from the shiny base side of the film, with the emulsion on the outside of the roll. The first generation copy is viewed using the dull emulsion side of

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

Following aspects would a

the film, with the shiny base on the outside of the roll. Reader/printers are designed to minimize the wear on the front of the film since only working copies should be used

dd to the challenges in developing combination products:

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

When an original is viewed the wear is on the delicate emulsion.

Image Quality Many companies did not follow good practices or standards when making the original f

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

ilm, so image quality is often bad. They may also have been filmed on a white background so it is hard to determine the documents edges.

Retrieval Time Most people

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

islike microfilm, primarily because retrieval is time consuming and poor image quality makes the documents difficult to read. Document retrieval requires physical proximity

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

to the film viewing equipment. Searching for a particular document on microfiche may require scanning 50 or more pages.

The future of microfilm

Every company with m

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

Professional from academic institutions, pharmaceutical industries, health care indust

crofiche has several options:

- Convert paper and digital images to microfilm.

- Support multiple storage media.

- Convert the film images to digital images only when they

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

are needed (on-demand conversion).

- Do a bulk conversion of the older film images to digital images.

This decision is usually made based on the cost of storage for the va

.

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

ious media option. Although storage costs for microfilm are less than that of electronic storage; when you consider the time and costs of retrieval; the overall costs of mai

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

Companies that provide selfless information through particip

ntaining microfilm is much higher. Most companies quickly recover the conversion costs. As a result the days of microfiche reader are going the way of the rotary dial phone

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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