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Legal and Regulative Issues for Labeling in Food & Beverage, Chemical and Pharmaceutical Industries

“Good manufacturing practices (GMP) refer to guidelines laid down by agencies which control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines are laid down with the intention of providing minimum requirements that a pharmaceutical or a food product manufacturer must meet while manufacturing drugs or food products, which then assures that the products manufactured/produced are of high quality and do not pose any risk to the consumer or public”. (End of USP Citation)

All manufacturers of drugs and biologics approved are subject to the FDA (Food and Drug Administration) of the United States’ labeling regulations.  While older drugs are not affected by the regulations, manufacturers of such drugs would be well served by voluntary compliance with the new regulations. These regulations are partially applicable also to the chemical and food and beverage labeling requirements.

It can be maintained that equipment which, on the immediate point of adding the content to the label are optimal for all the three industries. But it has naturally to be considered that such a system which can due to all to its technical capability may be over designed and therefore not economical for the specific application.

An intensive research on regulatory issues regarding labeling in the food and beverage, chemical and pharmaceutical industries shows, that in opposite to the direct manufacturing steps like container materials, hygienic behavior and clothing of the workers involved in the production process as well as the preconditions of the immediate components needed for making the products like purity and sterility, to mention only a few, the immediate labeling equipment is not mentioned expressively.

This may come from the fact that the labeling is usually done before the product containers are closed and sealed.

Nevertheless as little is mentioned regarding the constitution of the immediate hardware, WHO (World Health Organization) and FDA, regulate or recommend the contents of the labels very strictly.

The most relevant national organizations accept the ruling of the WHO or FDA, even more if they want to trade their products internationally.

So the companies intending to serve these markets need to offer a technology which has the engineering capacity to design and produce high end labeling machines.

The following list shows what in an extreme case the labeling requirements may be. All or even only portions of this requested labeling cannot be put on a single pre-print label as they are batch to batch variable:

  1. Name, address and emergency telephone number of the production company.
  2. Pharmaceutical dosage form, route of administration, quantity of dosage units.
  3. The batch and/or code number to identify the contents and packaging operation.
  4. Directions for use (reference may be made to a package insert.
  5. The storage conditions.
  6. Expiry date in a month/year format and that avoids any ambiguity.
  7. Keep out of reach of children” except when the product is for use in trials.
  8. Batch number

At a first glance this list shows how complex the requirement to a label can be. Surely there is a wide range from a pre-printed label for a batch of wine which need to be filled into a few thousand bottles to a single vial-single batch pharmaceutical operation.

It shows how far the requirements of the regulating agencies can go.

A technology oriented company might always have these wide range of requirements in mind; even they are not yet requested for an application he is doing the development for.

Being able to discuss the requirements as a solution which could be done with his client puts the manufacturer of a labeling system in a different league compared to his competitors.