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Lean manufacturing is a management philosophy that aims to get the right products to the right place at the right time and in 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

right quantity. Lean manufacturing focuses on the reduction of the wastes that decrease efficiency and increase costs. These was

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

Examples of combination products may in

tes include over-production, waiting time, processing, inventory, transportation, motion, and scrap. Lean manufacturing has been

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

ade popular by Japanese companies who have used these very effectively.

Some of the most popular techniques associated with lean

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

manufacturing are discussed below.

Workplace organization and visual management:

An organized workplace is one that complies w

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

Combination pro

ith the ?30-second rule.? This rule states that anyone should be able to find anything within 30 seconds. The ?5S? system of work

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

lace organization (sort, set in order, shine, standardize, and sustain) emphasizes removal of what is not used and employment of

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

shadow boards, signs, areas boundaries, and labels to help everyone find what is used.

Quick changeover:

Changeover time can be

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

defined as the time from the completion of the last good piece of one job to the first good piece of the next job. The main comp

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

nents of changeover time are preparation of the work area, paperwork, materials, tools etc.; removal and mounting of parts, tools

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

, fixtures and equipment; measuring and setting the equipment; and making trial pieces and adjusting where necessary. By watching

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

Following aspects would a

and analyzing current changeover procedures, it is possible to learn ways to reduce each of the components and minimize equipmen

dd to the challenges in developing combination products:

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

down time during the process.

Point-of-use storage of parts:

This means that every part needed to do a job is stored in the ar

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

ea that uses it. This technique offers reduced search time, minimal travel and material handling, and simplified storage.

Qualit

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

y at source:

This means that employees are certain that the products they are sending to the next workstation are correct. Gauge

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

, tools, and other inspection equipment can help employees to attain such certainty.

Standardized work procedures:

This means t

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

Professional from academic institutions, pharmaceutical industries, health care indust

hat tasks are organized in the best sequence to ensure products are being made the best way every time. Standardized work procedu

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

res bring consistency to the workplace and, therefore, should be documented.

These and other techniques such as cellular manufac

.

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

uring, in which all the resources required to complete the product are grouped in the most effective combination instead of group

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

Companies that provide selfless information through particip

ing the similar machines together as is done in traditional manufacturing, help the manufacturer improve their overall operations

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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