How does this Entire Pharmaceutical industry work
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How does this Entire Pharmaceutical industry work

I am expecting either you are working in the Pharma industry or you'll work in the future. At some point of time, you’ll definitely think about how this entire Pharma Industry ecosystem works.

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).

  • Pharmacovigilance

  • 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).

  • Production

  • 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 itself or it outsourced by Clinical Research organization. CROs are performing clinical trials for companies. There is many CROs in India e.g.

Pharmacovigilance: 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 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.

Process Development Laboratory (PDL): PDL department is responsible for devising new processes, or refine existing ones, to optimize the manufacturing process. Scale up the production process via plant trials, making changes to raw materials or components, and process parameters to ensure quality is maintained during large-scale production.

Technology Transfer Department (TT): The role of the Technology transfer department To elucidate necessary information to transfer technology from R&D to actual manufacturing by sorting out various information obtained during R&D and between various manufacturing places.

Packaging and Development. (P&D): Packaging of products is equally important as anything else. Packaging and development are responsible for the development of primary, secondary, and tertiary packaging for drug products as per product and regulatory requirements.

Drug Regulatory Affairs (DRA): The responsibility of DRA is to ensure compliance with government and regulatory authorities' requirements. They are dealing with regulatory authorities of countries where we want to export and launch our products. Regulatory professionals keep working with the authorities and different departments within the company to meet regulatory commitments with the health authorities. Regulatory Affairs also ensures the maintenance of the marketing license and leads life cycle extension activities such as broadening the indication of the drug, change of formulation, changes in the dosage, etc...

Corporate Quality Assurance (CQA): The word corporate says everything about this department. CQA is like the head of Quality Assurance, now you may be thinking what it means so let me explain to you. Suppose any Pharma company has more than one manufacturing unit, each unit regulated by certain policies and SOPs. Now here is the problem;  One company, different units have different policies and SOPs for the same thing which causes a huge compliance gap. To fulfill this gap and harmonize all company units is the main responsibility of Corporate Quality assurance.

Production: The department which executes everything, The drug discovered by R&D, the formulation developed by F&D, Packaging developed by P&D, and guidelines and policies provided by CQA with DRA.Here commercial production is carried out of any product with help of all supporting departments e.g. Engineering, QA, QC, warehouse, etc. The production department has a complete setup of Equipment and technicians with all required facilities.

Quality Assurance (QA): The role of QA is too broad and important. They are responsible for ensuring each activity happens within the unit. They have to assure the quality of the Product by ensuring the activity of the Production department, QC department, Engineering department, warehouse department, etc.

Quality Control (QC): The role of the QC department is to test each component which to is used for manufacturing (raw material) and packaging ( packaging materials), area, equipment and ensure everything is within control limit and appropriate for use. Quality control and Quality assurance working together to ensure product quality. 

Marketing and Sales: Marketing and sales are the base of any industry and it applied to the Pharma Industry as well. If we talk about the domestic level then marketing and sales is a very important department, companies spend more than any other department because at the domestic level there is very tough competition between all brands and Medical Representatives are working very hard. They create demand which is supplied by the production department with help of all other departments.

 

Thanks for reading. Have a wonderful career.