Or 3 practices that ensure quality of pharma products
India has always played a vital role when it comes to shaping future of global health care. In fact, India is the largest supplier of generic medicines globally. This was achievable because Indian pharma companies produce competitive medicines at a cheaper cost than the US and Europe.
However, Indian pharma companies’ exports could drop if the exported products do not meet the ever-evolving compliance norms.
The compliance norms tend to change with the country because every country has its own way of doing things. Every country has its own culture and thus has its own way of doing things.
However, this divergence in regulatory practices makes it costlier and more difficult to follow every norm. The following 3 practices will try to help ensure that your final product complies with most pharma specifications.
Ensure proper quality checks:
The first step to ensuring that your pharma products are of the best quality is to ensure that you have an excellent quality team. Even the senior management needs get more involved with the quality of the products and not just be worried about the invoicing and sales. Along with the senior management’s involvement, you need to ensure that the quality team has complete authority. If the products do not meet the specifications, they need to be able to even hold the products about to go out for delivery. You need to convey the importance of a quality product to all the employees. With all the employees having one goal, you are sure to get a quality product.
Follow FDA guidelines:
India has the Central Drugs Standard Control Organization (CDSCO) that monitors the quality of the drugs in the country. However, it wouldn’t hurt to follow the US’s Food and Drug Administration (FDA) guidelines. With the changing leadership, companies could see relaxations when following FDA norms. This would be just to increase the output and business. However, it would still be beneficial to follow the current FDA norms. It is recommended that you do not take their scrutiny as too intense but as areas with scope for development.
Keep up with other international guidelines:
There are various other international guidelines that you may want to stay updated on. The important guidelines to look out for are those from International Conference on Harmonization (ICH). Members from ICH include administrative authorities from China, Japan, Singapore, Russia, European union, Australia and so on. One of their notable guidelines is ICH q7. This the guideline for the Good Manufacturing Practice regulations for active pharmaceutical ingredients. Other mentionable guidelines include ICH q9 that addresses risk management and ICH q10, which is for total management. Now, these are just guidelines and not rules. However, we still recommend following them.
Following these practices can sometimes hamper sales. However, these practices will ensure that your product always meets specifications. These practices will ensure that product rejection rates due to compliance issues is considerably reduced. With quality products, we can be sure that Indian pharma companies will always play a vital role in shaping the future of health care systems.
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