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In today’s hectic business environment, it is vital that we are all on the same page, right? But how do we know if we meet those standards? Business owners and executives can

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

avoid the uncertainty, and that’s where ISO 9001 certification comes in.

Standardizing Quality Systems

The ISO, or International Organization for Standardization, 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

established in 1947 to develop international standards for everything from electronics to management systems. Having over 13,000 standards currently in place, ISO has created

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

the auditing and certification process known as ISO 9001. This began the drive toward quality standards.

Improving Customer Satisfaction

Companies choose to implemen

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

t ISO 9001 and get certified because many customers and industries require it. By keeping customers happy, they can increase sales and profitability for their business. And if

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

Combination pro

an area of the company’s program appears to be too bureaucratic and non-value-adding, then it might also be an area for continuous improvement efforts.

Enhancing Company

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

Policy and Performance

Both customers and industries alike use ISO certification as a way to evaluate and audit their suppliers and products. Through an independent verif

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

ication process, customers can gain assurance of their suppliers’ products. And as a supplier becomes certified, the testing requirement is waved, which saves the company both

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

time and money.

Developing a Best Practices Process

Employed as a “Best Practices” model, ISO 9001 utilizes the philosophy of the “Plan-Do-Check-Act” continuous impr

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

ovement cycle to achieve requirements. This process approach centers around eight quality management principles used by management as a guide toward improving performance and

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

identifying the main elements needed in a good quality system:

1. Customer Focus

2. Leadership

3. Involvement of People

4. Process Approach

5. Systems Approach to Ma

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

Following aspects would a

nagement

6. Continuous improvement

7. Factual Approach to Decision-Making

8. Mutually Beneficial Supplier Relationship

Building Stable Processes

ISO 9001 polici

dd to the challenges in developing combination products:

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

es, procedures and forms can provide employers, managers and employees with a systematic and consistent approach to implementing policies, plans, procedures and work routines.

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

Instead of building their own policies and procedures from scratch, some companies prefer to hire professional writers that have already prepared a set of written policies an

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

d procedures to help on the way to certification.

Auditing a Company System

In the certification process, an independent registrar will perform an on-site audit of a

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

company’s operations to verify that it complies with the ISO standard. If the business complies, then that company will be registered as ISO 9001 compliant.

Effective Poli

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

Professional from academic institutions, pharmaceutical industries, health care indust

cies and Procedures

On the way to certification, a business can meet its ISO needs by:

• Using well-defined processes and procedures to build stable processes

• Trainin

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

g in the audit and certification process

• Continuously improving with ISO 9001 standards

Quality Management System

With complete procedures manuals for ISO 9001 Qua

.

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

lity Management System, required HR procedures, and an ISO training class, a template like an ISO 9001 Quality Manager Procedures Manual Series can help a business on its way

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

Companies that provide selfless information through particip

to ISO 9001 certification. Sometimes the effort can be very great, but companies typically notice a remarkable difference in efficiency and effectiveness after the first year.

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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