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You’ve made the plans, built the quality system and conducted the audit. So how do you register your company as ISO 9001 conformant? And how can you be sure you’re getting t

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

he most value for your investment? Here’s how the process works.

Certifying Your Company and Quality System

After your company's ISO 9001 audit, you will want to re

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

Examples of combination products may in

gister your company's quality system to show that you've met the requirements. And to do this effectively, you will need to follow eight essential steps.

1. Finding a Regis

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

trar

You’ll need to begin searching for an ISO registrar during the 2 to 3 months your company is still building its quality system. You can search the Registrar Accreditat

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

on Board (RAB) at http://www.rabnet.com to select the registrar right for you.

2. Selecting a Registrar

Select a registrar that has experience within the scope category of

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

Combination pro

your specific industry, which you can also find on the RAB site. Keep in mind accreditation, scheduling issues, fees and comfort level when selecting the registrar right fo

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 you.

3. Creating an Application

A company and a registrar will agree on the application, contract. This defines the rights and obligations of both parties, and includes

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

iability issues, confidentiality and access rights.

4. Conducting a Document Review

The registrar will require a copy of your quality manual and procedures to verify that

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

all the requirements of the standard are addressed. Allow 2-4 weeks in advance for the registrar to fully review all of the necessary documents.

5. Determining Preassessmen

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

t

Though optional, this 2-4 week initial review of the system identifies any significant omissions or weaknesses. It saves time and allows the registrar to assess any issue

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

and resolve logistics before the actual assessment audit.

6. Issuing an Assessment

During the audit, or physical onsite inspection of procedures in action, the auditors w

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

Following aspects would a

ill issue findings if they assess anything that doesn’t meet requirements, or nonconformities. The length of this step will depend on the scope of the audit and the size you

dd to the challenges in developing combination products:

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

r organization.

7. Completing ISO Registration

After all of the findings are put into the audit report and nonconformities are addressed, your company has the option to re

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

gister as ISO 9001 conformant. You will receive a certificate and can also be listed in a register, which the company can use to publicize its registration and use in advert

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

sing.

8. Checking with Surveillances

To ensure that the system is maintained and that changes don’t result in deficiencies in the system, registrars perform regular survei

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

llances of the system. Over the three-year period of your certificate, auditors will perform one full and two partial checks of your system.

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

Professional from academic institutions, pharmaceutical industries, health care indust
b>

The Document Review and Preassessment typically require 2-4 weeks each. However, the number of registrars and the number of days for each stage of the registration audit
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
depends on the size and complexity of your organization. So set target dates accordingly to allow both you and the registrar time to fully prepare.

Strong Return on Your
.

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
Internal Audit Investment

Always keep in mind, registration should provide you with valuable feedback to improve your system. So make sure to seek the appropriate regi
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
strar, and take full advantage of the entire audit process. After all, it’s your company, it’s your registration, and so make sure you get a strong return on YOUR investment

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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Digg It - ISO 9001 Registration - 8 Steps for Success

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