Over the last few years, there has been a continuous improvement in the quality of life of people worldwide. There are many factors that contribute to this development, including quality pharma products, vaccine development, and new medical equipment to name a few. With the advancement in the healthcare industry, people have started living a better and quality life. However, despite such development in the medical sector, various life-threatening diseases like COVID-19, diabetes, and cardiovascular Illnesses continue to pose potential challenges.
Due to this, it has become more important than ever to manufacture high-quality pharmaceutical products to ensure the safety of the patient. Whether small capsules or large syrup bottles, any pharma product not made as per the required safety standards can pose potential risks to a patient’s health and can take a big toll on your financial health too.
For instance, in 2010, GlaxoSmithKline, a popular drug firm paid $750 million to resolve the False Claims Act. The company was sued to sell poor-quality drugs. Just like other sectors, it is vital to ensure that pharma products are made in compliance with the highest quality and safety standards.
Here comes the role of GMP, short for Good Manufacturing Practice. Continue reading the blog to know the meaning, importance, role, and 5 Ps of GMP in the pharmaceutical industry.
What is Good Manufacturing Practice?
As per the World Health Organization, Good Manufacturing Practice (GMP) is a set of protocols to ensure pharma products are manufactured and controlled in compliance with quality standards.
In other words, Good Manufacturing Practice or GMP defines a standard set of safety guidelines that must be followed by certain industries like the pharmaceutical sector to manufacture quality products, eventually reducing the risk of adverse consequences.
Furthermore, GMP outlines specific best safety practices to help the pharmaceutical industry maintain the quality of products before launching them into the market.
Importance of GMP Certification For Pharma Products
GMP plays an important role in the pharmaceutical industry. It includes a checklist of procedures and documents created by global communities in partnership with the pharmaceutical industry to ensure the highest standards of quality and safety of products. Some of the reasons that make the GMP certification must for the pharma products are
- GMP ensures pharma products meet the quality and safety standards.
- Products made as per GMP protocols reduce the serious health risks to the customer.
- Following the GMP guidelines can save your company from financial and customer loss.
- Lowers the chances of customer liability.
- GMP safeguards the reputation of pharmaceutical manufacturers by reducing risks.
- Save money on penalties and lawsuit compensation.
- Get ahead in a highly competitive marketplace.
- Save big on time, money, and resources.
- Allows manufacturers to improve product quality and reduce potential liability risks.
- Many countries don’t allow the exchange of pharma products if they are not certified.
5 Ps of Good Manufacturing Practice
There are 5 key pillars of Good Manufacturing Practices (GMPs) that ensure that the pharmaceutical industry implements strict protocols from start to end of the product production process. Here are the 5 ps:
Employees are the biggest asset of any company. And the pharmaceutical industry is no exception. All employees must strictly adhere to product quality and manufacturing standards. Therefore, it is very important to provide them with proper training to ensure jobs are done in the right way.
All employees associated with the product manufacturing process must undergo training to get a better understanding of their job and responsibilities. Furthermore, their performance must be monitored and reviewed regularly to avoid any problems down the road.
Procedures define guidelines that must be carried out to perform other important tasks, including pharmacovigilance and batch recalls to get a better outcome. All employees must be aware of all products and if needed train them.
Furthermore, it is important to determine and report in case any procedure is not working the way it should.
3. Products and Raw Material
It is vital to test, compare, and double-check the quality of every pharma product before introducing them into the market. Furthermore, the raw material used to make the product must have precise specifications at every manufacturing level.
From product packaging to testing, and sampling, implement standard guidelines to maintain the quality and safety at every level of the drug manufacturing process. Finally, keep note of test results to ensure manufacturers can audit all the products.
Last but not the least, every product must be handled with the highest accuracy and precision to avoid any hurdles.
Clearly defined processes are critical for manufacturers to follow legislative standards associated with GMP and product quality and safety.
Whether small or large, every process must be well-defined, documented, consistent, and allocated to all employees. Apart from that, evaluate to make sure all operations are in compliance with current processes and are meeting the set standards.
The auditor can demonstrate compliance at any time and can examine the processes to determine any scope of improvement.
5. Premises and Equipment
People often use the words “facility” and “premises” interchangeably. However, in the pharmaceutical sector, premises beyond the facility. This is because there are certain protocols that must be followed by the surrounding area. On the other side, premises define infrastructure and systems around cleanliness to avoid risks like cross-contamination and fatalities.
Furthermore, make sure to place and store all equipment in a safe location to prevent any failures down the road. Additionally, evaluate all equipment to ensure they are working efficiently. Plus, there must be a proper procedure to clean equipment and premises.
In The End…
Above all, Good Manufacturing Practice ensures that every pharma product undergoes rigorous testing for optimal effectiveness. Moreover, GMP also guarantees the quality of ingredients used in drugs and other pharmaceutical products and devices used in medicine are up to the mark.
Needless to say, it ensures that the pharma industry follows a certain set of safety standards to manufacture high-quality products. In case you are planning to invest in the pharmaceutical industry, make sure the products meet the quality and safety standards. Thinking to invest in the pharma franchise business in India but don’t know where to start? No worries!
Get in touch with the best pharma company in India—Vivaceutical. The team of experts can guide you to make a successful business career in the pharma industry. For further information, read: How to Start a PCD Pharma Franchise? A Step-by-Step Guide.