How does this Entire Pharmaceutical industry work?
Updated: Dec 18, 2021
I am expecting either you are working in the Pharma industry or you'll work in the future. At some point in time, you’ll definitely think about how this entire Pharma Industry ecosystem works.
“The pharmaceutical industry is the backbone of the whole health care industry.”
Now here I’ll explain how each segment of the Pharma Industry works and how they are connected.
So first Iets know all the segments then I explain them one by one.
Research and Development (R&D).
Clinical Research Organisation (CRO).
Formulation and Development (F&D).
Analytical Development Laboratory (ADL).
Process Development Department (PDL).
Technology Transfer Department (TT).
Packaging and Development. (P&D).
Drug Regulatory Affairs (DRA).
Corporate Quality Assurance (CQA).
Quality Assurance (QA).
Quality Control (QC)
Marketing and Sales
Research and Development (R&D)
A department that shapes the future of the Pharmaceutical Industry as well as the healthcare industry by discovering new drugs and new molecules. Drug discovery is a long and very costly process, It takes almost 12 years and hundreds of millions of dollars.
Clinical Research Organisation (CRO)
During the drug discovery, there is a phase of Clinical Trials, Clinical Trials conducted by companies themselves or outsourced by Clinical Research organizations. CROs are performing clinical trials for companies. There is many CROs in India e.g.
Syneos Health etc…..
Pharmacovigilance is responsible for monitoring the safety of products by detecting and preventing adverse reactions. During clinical trials of new drugs, side effects are reported and after launching in the market it should be checked and confirmed that the drug shows the same side effects which were reported during clinical trials. So Pharmacovigilance has a very crucial responsibility in the Pharmaceutical Industry.
Formulation and Development (F&D)
Any drug discovered for lifesaving can not help us unless it is developed as Dosage Form (tablet, capsule, liquid or parenteral, etc). So from here, the role of the Formulation and Development department has started, they develop formulations for drugs and make them ready to use for us.
Now a newly approved drug has become an Active Pharmaceutical Ingredient and it needs other inactive ingredients (excipients) to be developed as Dosage Form. Formulation and development department performing tests and trials based on the property of drug and developing a Master Formula which was referred for commercial manufacturing of drug product by the Production department as a base document.
Analytical Development Laboratory (ADL)
The role of the ADL department is to develop analytical methods for developed dosage forms and APIs as per regulatory requirements and provide them to the Quality Control department so they can analyze during commercial production.