Why Labeling Compliance is Crucial for Pharma Companies
It is well-known that, when it comes to manufacturing pharmaceutical products, every process and component ― from the software to machines ― should be validated in order to ensure that there are no quality or safety problems. Companies operating in the pharmaceutical industry produce medications. So, any error or omission can cost the consumer’s health or even life.
The Role of Labeling Compliance in the Pharma Industry
Some beginners may fail to realize that, but checking the compliance of documents plays a crucial role. Printing labels and instructions is the final stage of the production process, but it is not minor. In fact, there are no insignificant details in drug manufacturing.
When a customer buys a medicine, its packaging is the first thing he sees. It is the detail, which makes a dramatic impact on the manufacturer’s image. In case there are any misprints or mistakes, that may create the impression that the brand is not reliable enough. The point is that any misprints or omissions may be the signs of counterfeit products as well. Consumers cannot check the quality of medications, so, everything they can do in order to protect their health is to make every precaution to avoid suspicious items.
In addition, any errors or omissions in the information presented on the pack or in the information leaflet may lead to confusion and, consequently, to adverse health consequences, including fatal ones.
As a result, in most countries, including the USA, regulatory bodies pay special attention to the compliance of labeling with national standards. One should also note that checking the quality of packaging and information leaflets is easy enough. The representative of the regulator does not even have to go to the factory to do that, most pharmaceutical products are available at every and each drugstore.
Sure, in case there are any violations detected, that is likely to lead to a product recall, a fine, a shutdown or some other sanctions. No doubt, such measures will inevitably lead to significant expenses, losses of profits and spots on the reputation of a company. Regardless of the scale of a brand, those consequences will be hard to manage. So, it is highly advisable to implement validating systems beforehand.
At the same time, many manufacturers, operating in the USA, fail to realize that their labeling does not meet the requirements of the FDA. They focus on developing new medications, monitoring the quality and safety of their goods, marketing, patenting, while labeling is frequently overlooked until the first problems occur.
The Crucial Facts about Labeling Validation
The validation of labeling is an indispensable component of Good manufacturing practice (GMP) ― the system that is aimed at ensuring that pharmaceutical products fully meet the current quality standards. Sticking to it, manufacturers can ensure that their products are both effective and safe. The FDA was the first governmental agency to introduce GMP. But, as of now, this system has been widely adopted abroad: in the European Union, the UK, India, Australia and other countries.
According to the GMP requirements, every pharma company should present in a documented format that all the processes, methods, tests and equipment used can ensure that the quality of its products repeatedly meets the current standards. Every stage of the production process should be validated.
Here is the list of documents related to the validation process:
- Standard operating procedures;
- Validation master plan;
- Validation protocols and reports;
- Qualification protocols and reports.
Let us have a look at the statistics. In 2018, 9% of all medical device recall cases were associated with labeling issues. In many cases the reason for a recall was printing errors. There is a wide range of factors that can lead to misprints or problems with readability ― from typos to technical errors, like empty print ribbons, ink quality issues or equipment failures. In case the personnel of the company fails to detect that until the product reaches the supply chain, negative consequences are practically inevitable. Some consumers may misinterpret the crucial information, others may avoid buying and using the product due to doubts about its quality and safety, and the regulator is very likely to learn about the violation and to implement some kind of sanction.
That is why experts insist that every manufacturer should get and apply reliable validation tools and methods to detect potential labeling violations as early as at the stage of production. Companies should not wait until adverse consequences or sanctions to take decisive steps. Managers should scrutinize all the current labeling requirements, create an effective validation system, organize training for staff members and monitor the quality of both labels and patient information inserts on a constant basis.
Sure, the labeling requirements tend to change from time to time. So, to avoid violations, every pharma company should keep track of the news.
To sum up, one should note that today manufacturers can make use of the specialized software that helps to meet the labeling requirements. Such products can make their lives much easier. The main point is to choose the reliable developer.