Main Subject - Business

Which documents must I keep for ISO 9001?

In addition to the legislative requirement for your business to keep certain records ISO 9001 2000 requires your business to retain other records to demonstrate com

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

pliance with its various clauses.

From an ISO 9001 2000 viewpoint records are documents generated whilst operating your Quality Management System. Typical examples are records of management reviews, purchas

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

Examples of combination products may in

orders, sales orders, test results and internal quality system audits.

An ISO 9001 2000 consultant can be very helpful to your business in deciding which records are required and those that are not.

The s

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

andard is not specific about how long your business must retain each record but in order not to fall foul of your own Quality Management System, or the law, you might like to consider the following.

If your

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

business offers a period of (x) years guarantee with its product you must keep associated records for at least (x) years.

If your business sells products that have legislative requirements for product test

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

Combination pro

ng you must keep associated records for the life of the product and sometimes longer.

Any legislative requirement for you to keep records associated with your product or service.

Records can be in many for

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

ats including computer generated records such as those maintained by the Easy ISO 9001 2000® software package.

It would be wise to remember when keeping computer based records for long periods (say 10 - 30

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

years) the medium upon which the data is stored will deteriorate and therefore you must periodically validate its integrity. Another factor to consider with long term data storage is will a device still be

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

available in 30 years time to read the media upon which the data is stored? I still have computer programs on punch tape but I no longer have a punch tape reader! If you do not know what I am talking abou

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

here take it as validation of this advice. (Punch tape was a medium for storing computer programs and data in the 1960's and 1970's)

The following table identifies the specific records required by ISO 9001

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

2000. The list does not include records that your business might choose to retain voluntarily or those required by legislative requirements for your product or service.

Clause Document to retain, (Record)

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

Following aspects would a

5.6.1 Minutes from your Quality Management Review meetings, including any actions raised.

6.2.2 Education, training, skills and experience.(Sub clause-e)

7.1 Evidence that the realization processes and res

dd to the challenges in developing combination products:

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

lting product fulfill requirements. (Sub clause-d)

7.2.2 Results of the review of the requirements relating to the product and actions arising from the review.

7.3.2 Design and development inputs.

7.3.4 R

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

sults of design and development reviews and any necessary action.

7.3.5 Results of design and development verification and any necessary action.

7.3.6 Results of design and development validation and any

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

necessary action.

7.3.7 Results of the review of design and development changes and any necessary action.

7.4.1 Results of supplier evaluations and actions arising from evaluations.

7.5.2 As required b

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

the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring and measurement. (Sub clause-d)

7.5.3 The unique identification of the pr

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

Professional from academic institutions, pharmaceutical industries, health care indust

duct, where traceability is a requirement.

7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use.

7.6 Standards used for calibration or verification of measuring equip

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

ment where no international or national measurement standards exist. (Sub clause-a)

7.6 Validity of previous results when measuring equipment is found not to conform with its requirements.

7.6 Results of

.

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

calibration or verification of measuring equipment.

8.2.2 Internal audit results.

8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the rel

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

Companies that provide selfless information through particip

ase of the product.

8.3 Nature of the product non-conformities and any subsequent actions taken, including concessions obtained.

8.5.2 Results of corrective actions.

8.5.3 Results of preventive actions

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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