Process development is the process of creating new and improved production methods. It aims to optimize solutions to meet customer needs, maintain regulatory compliance, reduce costs and improve product quality.
Process development in the pharmaceutical industry is a collaborative effort between operators, engineers, technicians, marketers, and production specialists. It involves designing processes, testing different scenarios, developing prototypes, and implementing solutions.
In this article, we look at what process development is in the pharmaceutical industry and its scope.
Development Process Steps
- •Discovery & Development
- •Preclinical Research
- •Clinical Research
- •FDA Review
- •FDA Post Market Safety Monitoring
Discovery and Development
The first step in a product (drug) development process is the discovery of the drug. Many factors come into play when discovering a new drug, and they include:
- • The emergence or discovery of a new disease, where the researchers have to devise a remedy (treatment or product) for the disease.
- • Already-existing drugs that produce unexpected adverse reactions are different from the presumed or expected effects.
- • Carrying out a series of tests on various molecular compounds to find the perfect drug for an existing disease without any known remedy.
From these three deciding factors, the researchers create a large number of compounds. After further testing, however, only a few of these compounds make it to the development phase.
In the development phase, the researchers would then conduct a series of experiments regarding the compounds to find out relevant information like the biological effects and action of the compounds, adverse reactions, absorption and metabolism, and their relation to other compounds or drugs.
Once this information has been gathered, the researchers move on to the next phase in the development process.
After the development of the drug, preclinical research is conducted in the laboratory by the research scientists before the drug is tested on people. This research helps to ascertain that the developed drug ticks all the safety boxes perfectly, without the risk of being toxic, i.e., it does not contain any toxic materials that can harm people.
The preclinical research provides complete details regarding the toxicity of the drugs and the dosage at which the toxicity is reached.
Once this research is completed, the scientists then move on to test the effect of the drugs on humans.
Once confirmed that the drugs cannot harm humans, a series of studies are carried out on the human body to check the actual interaction of the drug with them.
Before commencing this research, the drug developers must submit an Investigational New Drug (IND) application to the FDA to approve this process, or else, the research cannot hold.
After approval is granted, the clinical research process, which takes place in a series of steps, begins.
The first step is the clinical trial plan, a protocol plan that the researchers develop to gather relevant information regarding the drug. The information gathered would determine certain factors like who the drugs would be tested on (Gender, Age, Race), the dosage that would be administered, the duration of the clinical research, and how the data is collated and analyzed.
The next step is the clinical trial phases which include phases 1,2 and 3. At each phase, the drugs are tried by participating volunteers for the research, and the effects are studied for some time. However, the number of study participants and the study length vary, with phase 1 involving a few hundred participants, studied for a few months, and phase 3 involving thousands of participants, studied for a few years.
After this phase, the results generated are collated by the researchers before moving on to the next phase.
For the developed drug to be reviewed by FDA, an NDA (New Drug Application) must be submitted once the clinical research is done. The NDA includes all reports, analyses, and statistics regarding the drug. It also provides other information like the patent and drug abuse data, directions for use, the intended labeling of the drug, preparing it, or being market-ready.
The FDA review team, which consists of a medical officer, pharmacologist, chemist, microbiologist statistician, and a project manager, then takes their time to go through the application and decide if the drug should be approved or not.
FDA Post Market Safety Monitoring
After the review and approval of a drug by the FDA, the drug is released for use in the market. However, the work is not done yet. More often than not, there are limitations to the drugs developed that need to be monitored.
FDA monitors these limitations periodically through the following processes:
- • Continuous drug surveillance, where they constantly monitor health records and databases to keep the safety of the approved drugs in check.
- • Monitoring drug-related problems that allow professionals to note and report any issues regarding the drugs.
- • Filling supplemental applications, which is essential when the drug developers want to make any changes regarding the drug.
Each development process is critical and time-consuming, and as such, the principles employed in the development processes must cater to and balance them out, where necessary, and that’s exactly what eLogBooks and eForms accomplish.
Deploying eLogBooks, during the development processes, can support equipment-related activities such as usage, calibration, cleaning, documentation, maintenance, and repair to save time and effort that could be used to focus on other areas of product development.
In the course of the laboratory setting, especially during the clinical trial phase, eForms support information gathering and documentation to ensure that the necessary data is securely captured at the source.
OpsTrakker supports this process in a GMP manner to ensure that valuable data is captured to support scale-up for life-saving treatments in a cost-effective manner. Ready to simplify your development process? You can reach us at OpsTrakker.