The pharmaceutical industry deals with many complex operations, and checking the quality of pharmaceutical raw materials is one of them. And why not? After all, checking the quality of raw materials is crucial to ensure a safe and effective drug for the patients.
Besides that, quality raw materials are also important to ensure your drug responds efficiently under all circumstances and to all groups. The medicines made with those raw materials are not specific to a particular group in general.
That’s why active pharma ingredient manufacturers always pass the drug through various phases of clinical trials and a rigorous testing procedure to ensure quality pharmaceutical raw materials.
But what exactly are those raw materials, and how can we test them for their effectiveness and safety? Moreover, what types of raw materials can be used to create new drugs for treating various illnesses? Let’s uncover answers to all such questions in our blog below!
What are Pharmaceutical Raw Materials?
The pharmaceutical raw materials are the core ingredients through which the companies can make new medicines. Pharmaceutical raw materials are divided into APIs (active pharmaceutical ingredients) and excipients (inactive pharmaceutical ingredients).
APIs are the main materials that inhibit their properties in medicine. They are, in other words, the active pharmaceutical ingredient that generates the desired pharmacological effect in medicine. On the other hand, Excipients are generally inactive and majorly used as a carrier of the APIs.
Some journals also classify pharmaceutical raw materials into three types. To name them, we have:
Raw Material for Excipients
Excipients are majorly the drug carriers for APIs. They are pharmaceutically inactive, i.e., they do not show any medicinal effects. Generally, a medicine contains a small part of the active ingredient and the remaining part of the excipient.
Raw Material for APIs
APIs are also known as active pharmaceutical ingredients. They are the actual drugs that show the pharmaceutical effects of a medicine. They are crucial as even a small mistake in their quality checking can lead to huge losses in terms of life, money, and brand reputation.
Raw Materials for Packaging
The outer covering in which medicine is packed is known as packaging material. In most cases, aluminum, plastic, and glass are used as packaging materials for pharmaceutical ingredients. Sometimes polymers are also used as packaging materials.
Why is Quality Important?
Pharmaceutical raw materials testing is important for API and active pharmaceutical ingredient companies. Apart from effectiveness and security, several other reasons show the importance of testing pharmaceutical raw materials.
Let’s discuss a few of them below in our blog:
- Raw materials testing ensures that the active or inactive ingredients used in the medicine preparation are suitable for the intended use. There are many APIs and excipients that are available in the market. However, you only need to choose one that shows the best results in treating a certain disease.
- You can know how your end-product will behave when formed by testing pharmaceutical raw materials. You can learn the possible side effects and the duration for which the products work actively on any patient.
- The purity and quality of the raw materials are also known through testing.
- You can easily check whether the medicine should be given in capsule or tablet form for maximum benefits.
- Last but not least, pharmaceutical raw materials testing ensures that your product follows all the guidelines by FDA and state authorities.
Following the Checklist to Ensure Pharmaceutical Raw Material
So we now know the importance of ensuring quality pharmaceutical raw materials for safe and effective medicine creation. But what are those guidelines throu9*gh which the quality of any drug or API is measured? Let’s look at the checklist followed by API manufacturers to ensure quality raw materials. –
- Before final launching, all the drugs and raw materials must be approved by the State FDA and the Central Drugs Standards Control Organisation (CDSCO).
- It would help if you were very sure about the raw materials used to prepare the final drug. The final characteristics will only be present based on the raw material used.
- Everything, including material analysis, DSC analysis, chemical tests, physical characterization, NMR testing, FTIR testing, and more, should be carried out according to the norms provided by the State FDA and concerned authorities.
- The quantity of the raw materials used to prepare the medicine should be carefully examined. Even a small mistake can lead to huge economic and brand reputation losses.
- The sampling of the raw materials used by API manufacturers and the finished products should be in sync with the supporting SOP.
- It would help if you recorded all the sampling procedures, tests, and other quality checks with the raw materials. Also, the tests and sampling should only be carried out with the framed protocols.
- The experts should review each MOA, and proper actions should be taken based on the outcomes obtained from the quality checks.
- The machines used for the checks must be suitable for checking specific raw materials.
- The concerned authorities must validate the testing methods, and the safety of the raw materials should also be checked before performing any test.
The advancements in medicine and a growing number of demands each year have added to the list of active pharmaceutical ingredients. As such, the API manufacturers and active pharmaceutical ingredient companies strongly needed protocols to check each new API’s effectiveness and safety. Hence, they follow certain protocols and pass their APIs through a checklist for a safe and effective drug to accomplish this task. That checklist ensures that the API manufacturing company followed all the safety measures while creating the new medicine.