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Manufacturers of products such as pharmaceuticals, food additives, cosmetics and foodstuffs, are subject to the special regulations of approval or monitoring bodies such as the FDA, EMEA, etc. which govern the development and manufacture of this type of product. In these sectors, the packaging of consumer goods is subject to the same guidelines as those applying to the products themselves. At the same time, products not only have to be in compliance with regulations applicable in the country of origin, but also need to comply to guidelines in place in all countries in which the products are sold.
The impact of an error (for example, in a leaflet) can therefore be just as dramatic as an errors in the products themselves. For this reason, the regulatory bodies demand SOPs (Standard Operating Procedures) from each manufacturer, with exact specification of instructions in artwork processes, plus detailed documentation for each operational step in all artwork generation (or modification) processes. Artwork is thus only validated for application for a packaging item if the documentation provides proof that all planned process steps have been adhered to. This person-related proofing and release process requires the involvement of the co-workers responsible in the relevant departments, such as:
- Text & Design (graphic realization proofing)
- Marketing (checking compliance to CI specifications)
- RegAffairs (checking compliance to legal requirements)
- Production (technical specification proofing)
- Purchasing (checking compliance to specifications by suppliers)
- Sales & Marketing (checking compliance to customer’s specifications)
- QA (checking compliance to quality criteria)
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Artwork can only be "released", i.e. achieve "ready to print" status in this way. Once a piece of artwork is released for a packaging item, its further application is closely administered.
Let's look at an example:
 In connection with changes to a packaging item, a Change Management department receives requests from (for example) marketing, regulatory affairs, international organization depts. These changes are planned and implemented at working group level. This change involves passing operational instructions to the wide range of individuals involved in the process. On finalization of the changes, at the request of, for example, the purchasing department, the relevant print layouts are sent to the appropriate supplier. All of these steps, i.e. the request, change generation, proofing, release and launch need to be exactly documented, so that documents can be produced on demand even after a period of years. In an audit, the regulatory bodies can ask to see the documentation for a randomly selected item of packaging. For this given item of packaging, the generation process and the operational instructions attaching to it need to be documented. Documentation of the histories of operational instructions may also need to be produced.
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