What do pharmaceutical testing services do?
All industries developing products, such as medicines and medical devices and equipment, should first conduct pharmaceutical testing to ensure safe use.
One way to accomplish this goal is by performing an examination. However, what do pharmaceutical testing services do?
In this article, you’ll learn more about pharmaceutical testing and what providers do towards the safe use of drugs and medical devices.
What is pharmaceutical testing?
Pharmaceutical testing, more commonly known as a ‘clinical trial’, refers to a rigorously controlled experiment of a new drug or vaccine, invasive medical device, surgical procedure, or other therapeutic interventions that involved human subjects.
It’s an outcome measure conducted under the regulation of the Food and Drug Administration (FDA) before it is made available for public clinical use.
You probably heard about clinical trials going on during the pandemic. Volunteers or willing human test subjects participate in attaining this goal. Several biotech consulting firms and pharmaceutical companies are rigorously developing and testing new drugs to find out if they can create or increase antibodies against COVID-19.
This process is the pharmaceutical testing of potential drugs to find a cure for coronavirus. So what do pharmaceutical testing services do?
Pharmaceutical testing services
There are a wide array of options based on the medium used when it comes to pharmaceutical testing services. Licensed experts that do clinical trials are Ph.D. scientists, to provide reliable, comprehensive analytical solutions to ensure that medical products are checked for safety and move through the development cycle smoothly.
Regulatory experts and industry-leading technology are also utilized by pharmaceutical testing companies to meet their clients’ requirements and exceed their expectations. Here are the things that pharmaceutical testing services do.
1) Procedure development
A procedure development chemist produces reliable methods for consistent results, measuring an active pharmaceutical ingredient’s (API) concentration in a compounded dosage form.
Pharmaceutical testing services identify raw materials, antioxidants, preservatives, and impurities in a formulation to ensure the potency, performance, purity, and identity of a product.
2) Packaging materials testing
The quality of your products, including the packaging materials, must be checked for safety if you’re a manufacturer. Some packaging materials may leach harmful chemicals that can compromise public health and safety, which may lead to expensive product recalls and even lawsuits.
To avoid these problems, you can seek the help of a package research laboratory to test packaging and ensure that they are safe to use.
A package research laboratory has the right knowledge, skills, and facility to test and solve the complex challenges of packaging, such as:
- Cans that contain milk for enteral feeding.
- Bottles to contain liquids such as intravenous solutions.
- Cartons such as cartons for syrup form medications or containers to pack medical devices.
- Vials for vaccines.
- Bags and pouches for medical protective equipment and packing other medical supplies, like fertility kits.
3) Formulation and process development
Pharmaceutical scientists and chemists determine the proper formulation of a new drug. For instance, formulation and process development can detect poor solubility, poor physical stability, and gastric intolerability of a drug. During this process, a clinical trial is deemed necessary.
Generally, in a clinical trial, there are four phases:
- Phase Iinvolves testing the new drug, medical equipment, or procedure to fewer than a hundred healthy volunteers. It aims to establish the best mode of administration and optimal dosage as well as to detect any side effects or adverse reactions.
- Phase IIclinical trials involve randomly assigned 200 to 500 volunteers to the research and control groups. This phase emphasizes the immunogenicity (triggers immune response like production of antibodies) and the relative efficacy of drugs, medical procedures, and medical devices.
- Thousands of volunteers who are randomly assigned to study and control groups make up Phase IIIclinical trials, which aim to generate relevant statistical data.
- Phase IVinvolves exploring adverse reactions, specific pharmacologic effects, or long-term effects. After the FDA has approved the product, it is ready for distribution or put it on sale.
4) Batch release testing
Bringing life-changing drug products to the market by partnering with a product laboratory testing facility to conduct batch release testing before product launch and distribution, which involves the following:
- Formulation verification.
- Testing potency and purity.
- Impurity testing.
- Testing uniformity and identity.
- Sterility testing.
Pharmaceutical testing involves measuring the accuracy, strengths, and weaknesses of a medical product, determining its potency, efficacy, and proper use or dosage.
A pharmaceutical testing laboratory can help you test your products to ensure that they are safe to use by everyone before launching them to the market. Method development, packaging materials testing, process development, and release testing are just some of the many services that pharmaceutical testing laboratories offer, and can guarantee that a medication is safe to use.