Good Manufacturing Practices is a set of guidelines and regulations that all pharmaceutical manufacturers must follow to receive authorization to market prescription and OTC products. Getting a GMP certification online ensures you are well aware of the industry norms and adhere to them.
In the pharmaceutical industry, there are certain guidelines and regulations that companies and relevant parties must comply with to market their products. Such guidelines are denoted by the general term ‘GxP,’ an abbreviation for Good X Practices, where the ‘X’ represents a specific field or process to which the respective guidelines apply.
These GxP regulations are crucial for the pharma industry because there is no room for even minute errors regarding pharmaceutical products and their applications. Medicines of low quality can even become a potential health hazard, and in worst cases, their effects can even be life-threatening or fatal, as opposed to life-saving.
There are different categories of GxPs that companies within the pharmaceutical industry must follow regarding various processes such as clinical trials, production, and distribution. One of these categories is the manufacturing process, which is regulated in the EU by Good Manufacturing Practice (GMP). In this article, we will talk about GMP and how you can get GMP certification online.
What is GMP?
Good Manufacturing Practice, as the name suggests, is a set of guidelines and regulations that all pharmaceutical manufacturers must follow to receive authorization to market prescription and OTC products. Even the medicines and materials which are undergoing clinical trials must comply with certain GMP regulations in the EU.
If companies fail to adhere to such practices, they are issued warning letters from regulatory authorities. Even reputed manufacturers have been subject to such warnings, such as the 2009 incident of Bayer’s Berlin facility, which received Warning Letter: 320- 09- 09 from the FDA due to alleged GMP violations.
GMP compliance is necessary to ensure that companies follow the best practices to manufacture safe medicines without harmful effects and work exactly as intended. The guidelines apply to all stages of pharmaceutical manufacturing, such as primary and secondary processing, as well as clinical trials and development for new drugs with potential medical benefits.
GMP compliance is mandatory in the EU for pharmaceutical companies to acquire marketing authorization. But that is not the only reason why you should follow these guidelines. Here are some more significant factors that highlight the importance of GMP.
Importance of learning GMP
High Quality of Final Products
GMP lays down important guidelines for manufacturing high-quality medicines. The pharmaceutical industry is an important part of healthcare services, which is why the quality of medicines can never be compromised.
But what exactly does ‘quality’ mean in the field of medicine? In the most basic sense, high-quality medicine must fulfill two main criteria:
- It should perfectly perform its intended effect on the end users
- It should not have any harmful effects on the user’s health
Extreme care must be taken during the manufacturing process of medicines to ensure that these two criteria are met without fail. And the GMP guidelines lay down the necessary practices and measures for manufacturers to successfully do the same. Complying with such manufacturing practices means that your final products will meet the quality standards and will not be classified as substandard, out-of-specification (OOS), or falsified products.
Since GMP compliance is mandatory in the EU, pharmaceutical companies based overseas will have to follow these regulations to receive marketing authorization and sell their products in countries within the EU. Similarly, companies based in the EU also need to follow these regulations to market their products overseas. So in both ways, GMP is one of the key requirements for companies that plan to expand their market overseas.
Prevent Product Recalls and Subsequent Financial Losses
Product recalls are always a hassle for pharmaceutical companies. It hurts the company’s credibility and quality standards and leads to financial losses. The larger the quantity of recalled products, the more it hurts the company’s image and finances.
Even a tiny error in the manufacturing practice or slight negligence can lead to the withdrawal of large batches of products, causing the company to suffer huge losses, lose customers’ trust, and become subject to much scrutiny and investigation. Compliance with GMP guidelines helps companies to set up efficient manufacturing processes where such mistakes do not occur and avoid the possibility of product recalls.
Prevent Health Hazards for Customers
Medicines promote better health care and effectively treat diseases, conditions, and symptoms. However, poor manufacturing practices can compromise the quality of the final product, and the medicine may instead cause harmful effects on users. If such dangerous medicinal products are marketed on a large scale and used by many people, they can become a public health hazard.
Since GMP regulations include various measures to promote the production of safe-to-use medicines, it helps companies to prevent such potential health hazards.
Improve Production Efficiency
Summing up some of the above points, companies that adhere to the guidelines of GMP are able to create high-quality medicinal products successfully, prevent errors and negligence in the manufacturing process, and ensure the safety of people who use their products. That means they have very few setbacks and obstacles to worry about and can smoothly manufacture large batches of products while also meeting quality standards. Thus, GMP compliance improves overall production efficiency.
Get GMP Certification Online
GMP compliance is mandatory for pharmaceutical companies to market products in the EU. But as explained in the above points, the importance of GMP guidelines goes further. It benefits companies in various ways – in terms of product quality, finances, customer safety, overseas expansion, and production efficiency. Having in-depth knowledge by enrolling in a GPM course is crucial to sustaining in the pharmaceutical industry. This online GMP course has been developed by Dr. Ciaran McEnister, a Senior Pharmaceutical Executive with 25+ years of experience in Medical Device Development, Translational Research, and Pharmaceutical development. This 10-hour training course provides you with a certificate of completion and CEU/CPD accreditation.