October 6, 2015
The dynamic environment of pharma regulatory for packaging artwork has set forth huge challenges in front of pharmaceutical and life sciences companies in terms of meeting the latest mandates. Subsequent to the rapid updates in artwork regulations, companies are facing one of the most crucial phases in their lifecycles. Where on the one hand the existing product chain is running out of patent timelines leading to major financial challenges, on the other hand the traditional products are struggling to meet meeting the regulatory compliance gaps due to regulatory changes. Moreover the growing global markets are giving rise to expansion of new markets around the globe, posing a threat to the passive traditional markets.
To fix the situation incepted as a result of dynamic artwork regulatory challenges, companies are manifesting manufacturing of more variations and alternatives of their current products and launch their products in the emerging markets. Implementing this practice leads to changes in the physical packaging of the products as the components change, thereby making the artwork creation and maintenance, an intricate process to achieve.
For companies with an extensive product line distributed around the globe in different regions, a perfect balance between business process and product information management is required to keep up with artwork compliance. However regardless to the size of the organization, companies witness similar errors/defects throughout the artwork creation, few of which are discussed below:
Content Defects
This is a direct error that is observed in the detailed artwork information about the product. Errors like omissions or placing incorrect symbols in the information generally dive into this category.
Gross Defects
This is a major error that arises because of an important piece of information missing completely from the detailed product information. Such an information can be a recent regulatory update that entails changes in the artwork.
Technical Defects
The technical aspects of packaging one of such as barcode on the pack, may lead to these errors because of incorrect specifications or information about the product mentioned in the barcode.
Context Defects
This error implies that the information on the artwork is mentioned in an abstruse or incorrect way that may mislead the perspective of the information. Such errors may appear because of inappropriate use of symbols or special characters.
These errors in packaging artwork can bring about harsh implications for the companies in terms of revenue loss due to product recall if failed to meet the regulatory compliance or even put their reputation on risk in the global market. Regulatory experts around the globe recognize these risks and are dedicated to drive advanced operations that leads to superior packaging artwork creation following the regulatory environment.
It has been observed that lack of good communication and competence are few of the major reasons for these errors to appear. And so it is needed for companies to rely on trained specialists that are well acquainted with latest regulatory updates and are proficient in managing the pharmaceutical artwork creation lifecycle.
