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Pharmaceutical Manufacturing and Packing Sourcer
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From a regulatory perspective, working primarily with chemical industrial and retail products, there are several translation challenges businesses face when looking to market their products. During the process of creating a product label, questions concerning label translations will arise: what language is required? Are there exemptions for this product? Will the necessary information fit on the label? How can the quality of the translation be ensured?
The answers to these questions depend on the country-specific regulations, the required label content, and the methods of obtaining a translation. It is important to remember that there are many entities that rely on the content of a product label. These include regulatory enforcement agencies (customs), international shipping companies, manufacturers, suppliers, distributors, and the end user (retail or workplace). Each organisation has different responsibilities regarding the product labelling. Manufacturers, suppliers, and distributors are typically responsible for the generation of compliant labels. The Globally Harmonized System (GHS) of Classification and Labelling of Chemicals can apply to retail and the workplace, which could also include pharmaceutical inputs, i.e., excipients.
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About the author
Alison Senyi is a Regulatory Consultant at Nexreg Compliance, assisting with various SDS, labelling, and consulting projects. Alison finds the challenges of her regulatory role rewarding and enjoys taking an active role in bringing on new services to meet the everchanging compliance needs of the industry. Prior to joining Nexreg in 2016, she completed a Bachelor’s degree at the University of Ottawa, Canada, and a Certificate of Occupational Safety and Health from Algonquin College, Canada. Alison’s background in health and safety has given her a greater understanding of the hazards of chemical products, which motivates her to promote awareness about chemical safety and compliance.
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