The Undeniable Need for Digital Proofing in Regulatory Affairs
by Ryan Szporer
Still in its relative infancy as a discipline, regulatory affairs was created to meet a pressing need, regardless of the industry in question.
For example, in pharma, the Biologics Control Act of 1902 was the first legislation to regulate drug quality in the U.S., while American apothecaries date back to colonial times. Of course, medicine as a sheer concept dates back just a couple more years before that… illustrating how much regulatory affairs departments have had to catch up in what can only be considered a short period of time in comparison.
In any case, whether that aforementioned need is in the pharmaceutical (Food and Drug Administration; FDA), energy (Department of Energy; DOE), or financial industry (Securities and Exchange Commission; SEC), the overriding role remains the same. Regulatory affairs officers liaise with those governing bodies and different departments within the company to ensure the rules in every region in which a company’s products and services are distributed are met. Proofreading meanwhile plays a critical role in different facets of a regulatory affairs manager’s day-to-day duties. Digital proofreading enables those responsibilities to get handled as efficiently as possible.
The Responsibilities of Regulatory Affairs
Regulatory affairs responsibilities take the primary form of oversight of a product’s life cycle. Through each of the product’s development stages, there are strict rules and guidelines to follow to ensure compliance. Proofing figures in at several of these steps:
- Initial rule/ law changes are lobbied at the state and federal levels.
- Product/ drug applications are submitted to regulatory bodies.
- Briefing documents are compiled for the appropriate regulatory agency to review.
- Packaging copy created by marketing is sent for internal and external approval.
- Packaging and labeling updates are evaluated.
- Changes are applied across different product lines whenever necessary.
- Info is revised (like the drug formulation and dosage in pharma) to extend product life cycles.
In each case, the regulatory affairs department enters into or even drives the file-creation process. it is imperative the text and artwork be 100% accurate from a spelling standpoint and based on what had been approved internally. While this can be accomplished through manual proofreading, i.e., with the naked eye, digital systems have been proven to catch more errors early in the process, cut down on revision cycles, and improve overall efficiency.
Customer Safety and Post-Marketing Compliance
As an offshoot of the aforementioned tasks, the responsibility for getting products to market as fast as possible also falls on the shoulders of regulatory affairs associates and offices. Regulatory and compliance managers and coordinators must ensure products meet all requirements and that the tests to that effect have gone smoothly. Digital proofing solutions lend a helping hand in that regard.
Furthermore, regulatory affairs departments are generally in charge of post-marketing compliance. If safety issues arise after a product has gone to market, regulatory affairs coordinates with the appropriate agencies to issue a recall if necessary. Recalls can relate to possible contamination or issues with the manufacturing process or, yes, even the packaging.
From a packaging standpoint, digital proofing serves as a cover-all by ensuring even the smallest issues like missing or misplaced decimal points in dosage figures get printed properly. In an industry like pharma, such an error could prove to be disastrous and, in a worst-case scenario, lead to consumers taking fatal doses.
There’s only a risk of that happening if the packaging makes it to production. The importance of regulatory affairs departments thus becomes clear, as does the need for a digital proofing solution therein.
Despite political hurdles and an economic recession, Brazil is forecasted to move up in the pharmaceutical world. The Latin American behemoth was ranked as the world’s 10th largest pharmaceutical market in 2011 and is predicted to take the fifth spot by 2021.
by Mike Malz
The Food and Drug Administration is a government agency that operates under the United States Department of Health and Human Services. The FDA is responsible for protecting and ensuring public health in relation to drug and food products.
by Mike Malz
The term product quality can be interpreted in different ways, but perhaps the most crucial variable that determines what quality represents is the unique set of quality objectives integrated by a company.
by Marvin Magusara