The pharmaceutical industry is one of the world’s most massive, intricate, and beneficial industries today. It creates new developments which might be challenging to track in some cases. Despite this, the impact of these pharmaceutical innovations and manufacturing solutions is immeasurable as they sustain numerous lives.
This brings us to discuss the pharmaceutical industry and drug development process. Also, we shall examine the benefits of pharmaceutical manufacturing solutions.
Understanding the Pharmaceutical Industry
The pharmaceutical industry is a branch of the healthcare sector. It deals with drug discovery, development, manufacturing, and administration to prevent people from contracting diseases and improving lives. It also focuses on developing drugs meant to vaccinate or cure people.
Pharmaceutical companies develop products like topical medicines, oral drugs, and parenteral formulations. The industry comprises R&D (Research & Development) teams, drug manufacturers, biotechnology companies, drug marketers, and more.
Like others, the pharma industry is governed by several laws and regulatory bodies. Let us examine some of its contributions.
1. Disease Eradication
Pharmaceutical innovation includes drugs that can eradicate diseases from the ecosystem. Even though disease eradication can be challenging, pharma companies still research ways to achieve that.
The World Health Organization (WHO) says smallpox is the first and only disease eradicated on a global scale. In addition, seven other diseases almost wiped out are mumps, rubella, guinea worm, polio, elephantiasis, measles, and river blindness.
2. Shorter Hospital Stays
With pharmaceutical innovation, companies now develop drugs that can aid the faster recovery of patients. Consequently, this reduces the hospital stay of those patients. Instead of the initial eight-day hospital stay, patients need only 4-5 days.
3. Pain Management
Medical experts and pharmacists use drugs to alleviate patients’ pains. They also use drugs to manage discomfort, symptoms, or side effects of other treatments.
Drug Development Process in Pharma
Let us walk you through the drug development process every pharmaceutical manufacturing company takes to develop a drug and ensure its safety.
1. Discovery & Development
At this stage, researchers discover new medications. Identifying active ingredients from traditional medicine and classical pharmacology are two proven ways to discover new drugs.
Steps involved in drug discovery and development are identifying & validating targets, assay development & screening, developing APIs, etc.
2. Preclinical Research
Preclinical research determines whether a drug is safe to use. In addition, researchers gather information about the benefits, prescription, adverse effects, etc.
Some of the tests conducted here are in vivo, in vitro, and ex vivo assays. Researchers determine drug delivery, optimize formulation, and improve bioavailability.
3. Clinical Research
The first step is setting up a clinical trial in three phases. There, the pharmaceutical manufacturing company will answer questions related to their drug and determine who will be a part of the study. They will then get the FDA involved to seek permission to conduct clinical research and review it.
4. FDA Review
Once the clinical research is over, a pharma manufacturing company can send an NDA (New Drug Application) to the FDA. The NDA contains the new drug details. The FDA peruses the application to ensure that the company has checked all required boxes. If this is the case, the FDA will decide to approve the drug within 6-10 months.
5. FDA Post-Market Drug Safety Monitoring
The FDA still monitors a pharmaceutical innovation – a new drug after its approval. The body reviews and approves changes to the new drug, regulates drug advertisements, inspects manufacturing plants, etc.
Benefits of Pharmaceutical Manufacturing Solutions
Pharmaceutical manufacturing solutions are all that pharmaceutical innovation encompasses. Therefore, we shall look at their benefits.
1. Cost-effectiveness
A pharmaceutical innovation like an eLogBook won’t cost a fortune. Yet, it will deliver maximum results to a pharmaceutical manufacturing company. For example, an eLogbook helps a pharma company to monitor staff activities, manage equipment, and record accurate information about cleaning, maintenance, repair, etc.
2. Zero Errors
Adopting a pharma solution prevents errors that could lead to severe issues in drug manufacturing, distribution, and other areas. The absence of errors prevents jeopardy against human lives, counters the violation of the GMP (Good Manufacturing Practice), etc.
3. Digitalization
One core pharmaceutical innovation companies enjoy today is the ability to operate using digital technologies. Embracing this idea in a pharmaceutical company allows for remote work and managing batch workflows.
The pharmaceutical manufacturing company develops different pharmaceutical innovations. Adopting these technologies add huge benefits to the pharmaceutical industry.
OpsTrakker’s innovations improve manufacturing performance, safety, speed, and compliance to deliver the highest quality treatments to patients in need. Its pharmaceutical manufacturing solutions include eForms, Batch execution workflows, eLogbooks, and eDatasheet to achieve these ends. These innovations help companies to ease work processes and avoid errors. Are you ready to try them out? Get in touch to learn how OpsTrakker’s solutions can promote your digital transformation and eliminate paper logbooks and forms across your facility.