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The Law

From the 1st January 2006, new EU legislation came into effect regarding food hygiene regulations. This affects all food business operators who are now required to put into place, implement and maintain procedures based on the seven principles of H

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

ACCP.

What is HACCP?

Hazard Analysis Critical Control Point (HACCP) is a food safety management system designed to assist food business operators in maintaining hygiene standards, therefore proving that they are complying with the above legislation.

Ther

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

Examples of combination products may in

are seven basic principles of HACCP outlined below that you need to do:

1. Analyse Hazards – identify all potential hazards (microbiological, physical and chemical).

2. Identify Critical Control Points – identify the point at which a hazard could

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

ccur therefore harming the consumer.

3. Establish Critical Limits – set the parameters of the control points so that out of control activity can be identified.

4. Establish/Implement a Monitoring System to monitor the critical control points.

5. <

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

>Establish Corrective Action – establish corrective action to be taken when the parameters of critical control points have been breached.

6. Establish Procedures to Verify that points 1-5 are working effectively.

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

Combination pro
> to provide evidence that the HACCP system is working effectively – these reports should be made available on request.

How Can a Temperature Monitoring System Help You With HACCP?

Enforcement

Current legislation places the responsibility on the f
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
ood operator to make sure that their food is safe. HACCP has been designed to assist them in doing this.

Failure to Comply with Legislation Carries Serious Penalties

In most cases the local authority is responsible for enforcing food hygiene laws and will
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
take action against you in order to protect the public if necessary. It is often the case that enforcement officers will inspect premises without prior notice and can ask you to produce relevant reports and documentation in order to prove due diligence.

Prelimina
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
y Enforcement actions may include:

Taking food samples
Record inspection
Written letters requesting that problems are corrected

In more serious cases, enforcement actions can involve one or more of the following:

Serving of legal notices
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
Serving of hygiene improvement notices
Prohibition notices
Closure of premises
Prosecution, fines and even imprisonment

To prevent any of the above, you should invest
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
n a wireless temperature monitoring system that monitors your critical control points, alerts you when your set limits exceed their set parameters, and produces the reports you need to satisfy your local enforcing authority.

Legal Requirements

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

Following aspects would a
edule 4 of the Food Hygiene Regulations regarding Temperature Control Requirements states that foods that are likely to support the growth of pathogenic micro-organisms or encourage the formation of toxins are to be held at or below 5°C or at or above 63°C (this b
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
ing the danger zone).

Responsibilities of a Food Business Operator

The following specification relating to temperature monitoring has been taken from Article 4 of Regulation (EC) No.852/2004 of the European Parliament and of the Council of 29 April 2004 o
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
the hygiene of foodstuffs.

“Food business operators shall, as appropriate, adopt the following specific hygiene measures: 3.(c) compliance with temperature control requirements for foodstuffs;”

Use a Temperature Monitoring System as Your First Form of Defenc
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

The aspects of the law relating to temperature monitoring/control have been outlined above, however, the responsibility of proof rests with you as the food business operator. EHO’s can enter premises without notice, (at a time of day which is c
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
nsidered to be reasonable), and request to see audit trails and all due diligence data. It is becoming more apparent that pen and paper is just not good enough! Get an automated wireless temperature monitoring system for protection, accuracy and proof that your fo
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
ods are being ‘temperature- monitored’ appropriately.

It is also necessary to highlight that there are certain foods that are exempt from temperature control and can be kept at ambient temperature if they have been treated in a certain way and their packaging rem
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ins intact .e.g. foods kept in jars, canned foods or air-dried foods. Any specific instructions on packaging should also be taken into account.

Temperature control requirements should be understood and interpreted within the general context of HACCP.

HACCP cover
.

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
various aspects of food safety and hygiene of which temperature monitoring is a part. Hazards are identified and controls put into place to minimise, even eliminate the risk to the consumer.

Therefore being able to prove due diligence and have your stock and rep
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
tation protected is highly important. In addition you can run your business with the peace of mind that you are operating within the guidelines of HACCP and food safety legislation

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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