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The impact of Brexit is evident in almost every industry based in the European Union (EU) and the United Kingdom (UK). Pharmaceutical industry too not to be spared.
The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.
Packaging, labeling and “artwork” are crucial stages of a drug product lifecycle, as they are the main safety information sources for the end user. Any mislead in these processes may lead to product recalls. Hence, it is highly important for a manufacturer to contemplate all possible approaches to successfully implement them either in-house or by opting managed services i.e. to contract out....
Effective communication can bridge information gaps between two different ends of a process. With so many processes involved and with a need to communicate accurate safety information to the end user, the Pharmaceutical industry must employ utmost caution when taking its products to market.
The year 2017 was an eventful year for the Regulatory space, with several major happenings taking place across various industries such as: Pharmaceuticals, Biologics, Cosmetics, Medical Devices (MD) etc. While the MD industry witnessed the strengthening of MD regulations across the EU, the cosmetics industry saw advancements in the form of improved guidelines for cosmetic product safety.
Artwork designing and packaging is often treated as an outsourced business segment given the fact that not all the technical team members from the manufacturer’s side will have that creative outlook or the promotional perspective on the subject. Even if they possess the creative knowledge, due to lack of dedicated design suites they prefer it to be outsourced.
Keeping at par with industry trends and following the European Union directives, Turkey has recently introduced a new regulation on packaging, inserts and tracking of pharmaceuticals. On April 25th, 2017, the Turkish Ministry of Health published the Regulation on Packaging Information, Inserts and Tracking of Medicinal Products for Human Use in its Official Gazette.
With years of time spent on innovating new drugs, life sciences organizations, sometimes, take a backseat to allocate sufficient time for artwork design processes that result in inaccurate and incompliant marketing of products followed by product recalls affecting the overall costs.
Even when artwork packaging is often considered to be a seemingly insignificant back office job, Artwork Pack Management is one of the key processes in the stringently regulated pharma world.
With years of efforts put into new drug, device and cosmetic products’ development, what can be every manufacturer’s nightmare would be to see their product recalled from the market for incompliant artwork issues. According to a study, it is estimated that 35 to 40% of product recalls are attributed to mislabeling and packaging errors.
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