How do pharmaceutical companies work?

How do pharmaceutical companies/industries work?

Everybody knows medicines are prepared by Pharmaceutical companies. Medicines are to diagnose, treat, prevent, cure, and mitigation of diseases. The pharmaceutical industry or company is nothing but a place where research and development of drugs and manufacturing of medication are done. Pharmaceuticals are developed more and more precisely as centuries passed on. Every moment there are so many newly discovered methods, drugs, and medicines that are coming to the market. 

Today we will see how it works? 

The pharmaceutical company is a huge sector of this world we can say. Nowadays Pharmaceutical companies are getting more and more important compared to the past. The pharmaceutical industry is totally based on science and technology. 

Generally, there are 4 departments in the pharmaceutical industry 

1. Research and Development

2. Clinical Trial

3. Manufacturing 

4. Marketing and sales.

We will see every section involved in these 4 departments.  There are so many steps involved in these 4 departments and also in between these 4 departments. All these departments are dependent on each other.

1. Research and development: New drug application:

Research and development departments have so many steps. First is the discovery of a new entity meaning a "drug substance". Sometimes already discovered drug substance is used to develop medicine (ANDA Abbreviated new drug application). 

The form of any medicine is called a dosage form. Generally, the pure form of the drug is in the liquid or solid state. Eg. Many powders are compacted together to form tablets. So the tablet is dosage form. By using drug substances and other excipients dosage form is prepared because pure form of the drug is not feasible to have by the patient. The factor of the "dose" is very important. As per the age of the patient the dose is fixed. Sometime maximum daily dose can lead to a death.

There are so many factors affecting drug substances, so it is converted in to the dosage form that we are buying from a pharmacy and that is called "Medicine". 

2. Clinical trial:  

A clinical trial of medicines is done by the clinical trial department. Here in-vitro and in-vivo testing of products is done. How does the medicine work? is studied in this department. Actually, the clinical trial is also a big department. We will discuss it in my next post. 

After discovering a new drug substance, it is registered in the Food and Drug Administration (FDA) department. This is called a "new drug application".Then after getting NDA approval from the FDA, the pharmaceutical industry or research and development laboratory can work to develop the dosage form of the drug. 

On the newly established drug. Many clinical trials will be executed in a phase-wise manner. It includes the following;(Not limited to)

1. Establishing an effective dose concentration.

2. Evaluation of side effects of dose.

3. Evaluation of lethal dose.

4. Evaluation of in-vitro / in-vivo study.

5. Establishing dosage form.

6. Evaluation of drug interactions/Adverse Drug Reaction.

7. Evaluation of drug pharmacodynamics.

8. Evaluation of pharmacokinetics.

8. Evaluation of drug absorption studies.

9. Evaluation of drug hepatic metabolism.

10. Evaluation of bioavailability.

11. Evaluation of efficacy of the drug.

12. Animal studies.

13. Study on human volunteers.

14. Postmarketing evaluation.

For the registration of new medication, the above mentioned are the requirements of the FDA (not limited to) that have to be fulfilled by pharmaceutical industries. After successfully establishing all the above-mentioned criteria pharmaceutical industry can manufacture the medicine. However, at each stage there are chances for the failure of establishing one of the above will lead to a stoppage of research on new moiety. This will be the complete loss of money that was spent on the project.

Pharmaceutical companies have to take clinical trials on medicines they are preparing. Once the Pharmaceutical industry or R and D laboratory gets approval, now in the laboratory, small scale batches are executed to evaluate the drug stability studies and other quality control test procedure establishment. In this phase, analytical method validation activities (Project Trial batches), and stability studies are being tested. 

3. Manufacturing 

Now actual work of Manufacturing Section is starts here. The established formula at the lab scale will be scaled up in the manufacturing industry. The development of the scale-up process is called optimization batches, assessment batches, and/or exhibit batches. These batches are loaded for stability studies and after successful evaluation of stability data at accelerated conditions, this product can be submitted for FDA approval. Now, the FDA will evaluate the drug product and if it meets the requirement they will provide green single for manufacturing. From here commercial drug manufacturing activity can be initiated.

Once the manufacturing unit gets approval from FDA for that particular brand/ medicine then manufacturing starts. Research and development department share all documents and formula required to the manufacturing unit. Manufacturing unit starts manufacturing products in large amounts. Some samples go to the Quality control department. Quality control department do analysis of product and then once it is approved by quality head it is ready to dispatch from the unit. 

• Raw material and packaging material:

The actual process starts from the raw material and packaging material. Raw material and packaging material is ordered from approved vendors of the company. Stores department accepts the material with required entries and some documents from vendor. Then Quality control department taking samples from the material received for analysis purposes. After analysis of the material, it is approved by the quality head. 

• Production:

Then as per planning production department starts production. The production department gives intimation to the store's department regarding required raw material and packaging material. The store department dispenses all required quantities of raw material to the production department. If there is separate packaging department then packaging material is dispense to packaging department. Here manufacturing starts. Samples in the process for analysis is withdrawn by quality assurance personnel and handover it to the quality control department for analysis. It is a Bulk sample. 

• Packaging:

After completion of production activity, the Packaging department plan for packing. After packing again finished good sample, control sample and stability sample as per requirement is withdrawn by quality assurance personnel and handover it to the quality control department.  

• Testing:

As per Specification and Method of Analysis, analysis is done by the quality control department. Then it is approved by the Quality head. stability study of every product is done as per guidelines. This stability data is required to submit to the FDA. After approval of finished product, it is ready to dispatch. 

 

There are some more departments involved in this process. All departments are interlinked with each other. some are for support system like the engineering department and Information and Technology department. . Administrative department have Human resource department, finance department, environmental monitoring department. Other than this Production department, Store department, Quality Assurance department, Microbiology department, and Quality control department playing important role in the whole process. 

4. Marketing and sales: 

Once dispatch of the finished product done it goes to the market. Sales and marketing department have main role here to improve sales of product. 

Conclusion:

For establishing a new drug moiety, there is multiple application that needs to be considered. After approval, drug manufacturing can be initiated. Always consider that what we are manufacturing is a drug. A complete detailed evaluation will be done before getting consumed by the patients. Refer NDA application procedure for further guidance.