1. Purpose
The purpose of this Guideline is to describe the way in which artworks and printed package components should be created and controlled.
2. Scope and Applicability
This Guideline is applicable to all artworks and printed package components for inclusion in finished products.
3. Definitions
3.1 Marketing Company
The Marketing Company is the organization responsible for marketing products in a country. For the purposes of this Guideline the definition of a Marketing Company includes any manufacturing and/or packaging sites that may be part of the Marketing Company organization.
3.2 Packaging Site
A site where the particular medicinal product is packaged and/or labeled to produce ‘finished product’. A packaging site packing a product for a particular Marketing Company may be one of the following:
– a part of that Marketing Company organization
– a part of another contracted Marketing Company organization
– a company contracted to one of the above.
In the case of a larger Marketing Company that may have more than one packaging site in its organization, some of the responsibilities and activities identified in this Guideline may be discharged through a single group that acts for some or all these packaging sites.
3.3 Approved Text
Any text approved by the regulatory department of a Marketing Company that will appear on printed package components, e.g. labels, leaflets, pre-printed ampoules, tubes, foils.
3.4 Graphic Design
A decoration that will appear on a printed package component.
3.5 Physical Pack Design
A diagram of a package component showing allowable print areas and non-print areas (that is, areas reserved for bar coding, variable data, glue flaps, etc.)
3.6 Artwork
A combination of a physical pack design, graphic design and approved text which gives a complete definition for printing of a package component.
3.7 Printed Package Component
Printed packaging materials are printed and/or otherwise decorated packaging materials produced by a printer from an artwork. In the case of printed packaging components for finished products, the text, and in some cases the decoration, forms a part of the legal labelling and design of the finished products, (e.g. labels, leaflets, pre-printed ampoules, tubes, foils).
Some package components are printed during the packaging process. Such components fall within this definition.
Printed components added to packs to meet transport, hazard and other distribution requirements are excluded.
3.8 Finished Product
A product which is packaged and labelled for supply to a wholesaler, hospital, doctor, pharmacy or patient.
3.9 Multi-Market Pack
A finished product pack that is designed for supply to two or more specified markets.
3.10 Graphics Unit (Studio)
A group that prepares graphic designs and artworks based on a physical pack design provided by the packaging site and incorporating approved text provided by the Marketing Company.
A Graphics Unit may be:
– part of the Marketing Company organization where the product incorporating the graphics designs/artworks will be marketed
– part of another contracted Marketing Company Organization
– a company contracted to one of the above.
4. Responsibilities
4.1 It is the responsibility of the Marketing Company’s Regulatory Department to approve all text that will appear on printed packaging components for inclusion in the finished products to be distributed in its market. This approval will take into account the views and interests of other functions in the Marketing Company and will incorporate any external regulatory authority approval of labelling text and artwork that may be required.
4.2 It is the responsibility of the packaging site that will package the product to provide a physical pack design to the Marketing Company to use as a basis for an artwork.
4.3 It is the responsibility of the Marketing Company to ensure that artworks prepared on its behalf comply with the company’s Graphics Policy, to obtain the external regulatory approvals necessary for the use of these artworks, or text contained therein, and to provide these fully approved artworks to the site where packaging activities will be carried out.
4.4 In the case of ‘multi-market’ packs, it is the responsibility of either the appropriate group in Regulatory Affairs or the Marketing Company elected to manage a particular ‘multi-market’ pack, to ensure that each pack complies with:
– Company’s Graphics Policy
– the requirements of company’s Packaging Manual
– the labeling text and artworks approved in each market that will receive the multi-market pack.
4.5 It is the responsibility of the packaging site to send the approved artwork to the printer and to assure the quality and correctness (based on the artwork provided) of printed components delivered from the printer.
4.6 It is the responsibility of all those identified in Sections 4.1 to 4.5 to collectively manage the replacement of superseded versions of artworks, printed components and associated packed stock with new approved versions, in a secure, timely and regulatory compliant manner.
The appointment of someone in each Marketing Company to co-ordinate all change management activities on artworks/printed components should be considered.
5. Guideline
The responsibilities outlined above may be discharged through a variety of processes, with varying responsibilities within each Marketing Company and packaging site.
These processes and responsibilities should be described in local written procedures as outlined in the following sub-sections.
5.1 Preparation of Physical Pack Designs
The packaging site should have written procedures in place to describe how physical pack designs are prepared, approved and provided to a Marketing Company.
5.2 Creation and Approval of Labeling Text, Graphics and Artworks
The Marketing Company should have written procedures in place to describe the processes used for the creation, approval and version control of labelling text, graphics and artworks, and for supply of these to the appropriate packaging sites.
These procedures should address the responsibilities for change control and maintenance of document archives and databases for labeling text, graphics, artworks
and approvals thereof. The role and responsibilities of contractors should be included, together with the responsibilities within the company for interfacing with the contractors.
5.3 Graphics and Artworks Created by a Packaging
Site/Contractor on behalf of a Marketing Company When the Graphics Unit involved is not part of the Marketing Company, written agreements should be in place to describe the responsibilities of the Marketing
Company and the Graphics Unit involved. These should address the responsibilities for change control and maintenance of document archives and databases for labelling text, graphics, artworks.
When the Graphics Unit involved is part of the Marketing Company, the above agreements may be replaced by written procedures approved by the departments involved – see Section 5.2.
Each Graphics Unit should have written procedures in place to describe the processes used for the creation, approval and version control of graphics and artworks (based on market approved labeling text).
5.4 Interface with the Printers, Quality Assurance and Release of Printed Components for Packaging Operations Packaging sites should have written procedures in place that describe the processes and responsibilities for:
– the receipt of approved artworks (from a Marketing Company or from the sites own Graphics Unit)
– the supply of artworks to printers
– the receipt and quality assurance of printed components
– the release of printed components for packaging operations
– the correctness and quality of text and graphics that may be printed during the packaging process.
These should include change control procedures to manage securely the replacement of superseded versions of artworks, printed components and associated packed stock with new approved versions, in a timely and regulatory compliant manner, together with the destruction of obsolete printing plates, stocks of printed components, etc.
The procedures should also address the processes and responsibilities for the printing, quarantine and supply of samples of new or revised printed components that may have to be produced to obtain approval from regulatory authorities/agencies before they can be used in finished products.