The pharmaceutical industry is the place that is involved in the research and development of the new products, manufacturing of the pharmaceutical products, testing of the pharmaceutical products and supply of pharmaceutical products.
What Is the Pharmaceutical Industry?
Pharmaceutical Industries play an important role for the healthcare department and in the economy of a country because it is involved in the manufacturing of the medicines which are required for the treatment of different diseases.
Apart from fulfilling the needs of country patients, many well known and big pharmaceutical industries are also involved in the export of medicinal products and bringing money to their country.
Departments Of Pharmaceutical Industry
Following are the some main departments of the pharmaceutical industry,
Research & Development Department
Production Department
Quality Assurance Department
Quality Control Department
Validation Department
Stability Department
WareHousing Department
Engineering Department
Regulatory Department
EHS Department
HR Department
Marketing Department
Supply Chain Department
Accounting & Finance Department
Research & Development Department
The research and development department, also known as the R & D department, is a very important department of pharmaceutical Industries.
In developed countries, this department is responsible for the research of new drug molecules and the research of new molecules requires a lot of money and time as well.
The research team includes pharmacists and other experts who work hard to get the best results from the research and when all the trials and data is completed successfully this new drug molecule is launched for commercial use.
In underdeveloped countries the R & D department is involved only in the development of products meaning no research is carried out, only formulation of previously existing products is developed for commercial manufacturing.
Here the R & D department conducts different trials for the product formulation.The formulation trial which meets all the requirements is selected for commercial manufacturing.
Production Department
The production department is the backbone of the pharmaceutical industry. As the name indicates, this department is involved in manufacturing dosage forms.
All the manufacturing activities are carried out under the supervision of qualified pharmacists and trained staff.
Sub Sections Of Production
The production department is further divided into the following main subsections,
OSD Manufacturing
Liquid Manufacturing
Sterile Manufacturing
SemiSolid Manufacturing
Number of sub-sections or sub departments depends on the manufacturing facilities available and the licence granted by the regulatory authorities to the pharmaceutical industries. Some industries have all the above-mentioned subsections and many pharmaceutical industries have only one or two subsections like OSD only Or sterile facility only or OSD and Sterile etc.
OSD Manufacturing
OSD Full form in pharma means Oral Solid Dosage form.OSD in pharma is a very important department of the manufacturing plant.In the Oral solid dosage form department following main dosage forms are manufactured,
Powders
Granules
Tablets
Capsules
Dry Powder for Suspension
Lozenges, Pills etc.
Commonly used methods of manufacturing in OSD are wet granulation, dry granulation and direct compression for tablet manufacturing. For wet granulation large numbers of equipment are required like blenders,granulators and dryers.
Direct compression, also known as simple mixing,is the shortest method used for manufacturing.
Liquid Manufacturing
The liquid manufacturing department is involved in the manufacturing of liquid dosage forms. Some commonly known liquid dosage forms are given below,
Syrup
Solutions
Suspensions
Emulsions
Sterile Manufacturing
The sterile manufacturing department is involved in manufacturing of sterile products.A great care is required to maintain the sterility of the area. Sterile products manufacturing may involve the following,
Ampules
Vials
Infusions
Sterile Eye Drops
Sterile Ear Drops
Manufacturing of sterile products requires great care and critical supervision.
SemiSolid Manufacturing
The Semi-Solid manufacturing department is involved in the manufacturing of semi-solid dosage forms.
Examples include
Creams
Ointments
Jellies etc
Staff Of Production Department
A large number of personnel are involved in the working of the production department and can be categorized as follows,
Pharmacist
Supervisor
Operators
Helpers
Role Of Production Pharmacist / Manufacturing Pharmacist
The term production pharmacist or manufacturing pharmacist means all the seniors and junior staff
including Managerial and fresh staff.
Some key roles of production or manufacturing pharmacists are as follows,
Production planning is done according to the market demands.
Ensure timely production of products according to the plan.
Production Pharmacists are involved in the manufacturing activities of medicinal products.
Supervision of manufacturing process.
Monitoring of line loss during different stages of production.
Plays role in reduction of line loss and to improve yield.
Ensure proper utilization of equipment capacity.
Ensure smooth running of manufacturing operations.
Schedule proper machine maintenance for reduction of downtimes.
Ensure product compliance to various regulatory requirements.
Complete documents to fulfil regulatory requirements.
Training of staff.
Training of operators.
Coordinate with other departments for smooth running of operations.
Industrial Pharmacist Job
In pharmaceutical companies,the job of an industrial pharmacist requires a qualified person with a Pharm-D degree.
In simple words, a person with a Doctor Of Pharmacy degree is known as a pharmacist and can apply for jobs in pharmaceutical companies.
Supervisor, Operator & Helper
This staff is involved in operating machines and equipment.
Also involved in cleaning of equipment and area.
Quality Assurance Department
The quality assurance department is also important in the pharmaceutical industry. It is also known as the Q.A department.
As the name indicates this department is responsible for ensuring the quality of medicinal products.
A quality assurance pharmacist is also known as a Quality Insurance Inspector.
Role Of Q.A Inspector
Quality Assurance pharmacist is involved in the following activities:
Checking Of all manufacturing areas before awarding line clearance.
Involved in awarding Line clearance.
Ensure Implementation of different quality guidelines.
Responsible for In-process quality checks.
Collect samples after completion of manufacturing and submit samples to the quality control department.
Quality Control Department
The quality control department is another important department in pharmaceutical companies and is responsible for different analytical and testing activities.
All the medicinal products manufactured by a pharmaceutical company are delivered to the market after quality control testing.
All the products are tested at different stages to ensure that those products are manufactured according to the quality standards and are fit for patient use.
Example
If tablets are manufactured by wet granulation then the granular blend is tested to ensure that its assay is according to the requirements.
After testing granules, it is released for the compression stage.
After the compression stage, the compressed tablets are again tested for required standards and after compliance, the tablets are released for coating.
After coating, the process of blistering and packaging is carried out after proper testing.
The finished product is held in a quarantine area and after release it is dispatched to the finished goods store.
Subsections Of Quality Control
The quality control department is divided into different subsections, some main subsections are given as follows,
Raw Material Release
Finished Goods Release
Packaging Material Release
Raw Material Release
Raw material release section is responsible for testing all the raw materials and provides a release certificate after testing.
All the excipients and active pharmaceutical ingredients are sampled when reached in quarantine after receiving them from the vendor.
All materials are held in quarantine until before release.
Validation Department
The Validation department is involved in all validation activities performed in a pharmaceutical company.
When a new product is formulated and trials are successful and completed then it is ready to manufacture in the production area on a large scale.
The common concept is that the first three batches are considered validation batches and the validation department is involved in the manufacturing and testing process.
Validation is also performed when there is any change in the formulation,equipment or the design of the area.
Example
If a pharmaceutical company is manufacturing a product and there is a change in the source of the API of that product, the first three batches will be validation batches.
Product data is collected by sampling and analysing the batch at different stages. All this is done by the validation department in accordance with the production and R&D department.
Stability Department
The Stability department is also an important department in pharmaceutical companies.
It is involved in stability studies of new products and old running products.
WareHousing Department
Warehouses in pharmaceutical companies play an important role in the storage of different forms of finished product,packaging material and raw materials.
Warehouse department is further divided into the following,
Raw Material Store
Liquid Material Store
Packaging Material Store
Finished Good Store
Raw Material Store
The raw store is the place where all the excipients and Active pharmaceutical ingredients are stored and dispensed.
All materials received from the vendor are held in the quarantine area of the raw material store.
The quarantine area is the place where materials are placed after receiving from the vendor and are waiting for release from the quality control department.
All the materials released from the Q.C department are shifted to the release area of the raw material store and all the rejected materials are placed in the rejected area.
The released materials are given a green label,the rejected materials are given a red label and a yellow label is attached to the materials placed in quarantine.
Dispensing Of Raw Materials
According To the production need the dispensing order is prepared and sent to the raw material store.
The store pharmacist and Q. A pharmacist dispenses the materials according to the dispensing order.
All the dispensed materials are stored in the storage area of the raw material from where it is delivered to the production area on request.
Liquid Material Store
Liquid material store is the area where liquid materials are stored.
Liquid materials are also required for the manufacturing of different medicinal products and are dispensed according to the dispensing order.
Packaging Material Store
Packaging material store is the area where different packaging materials are stored and dispensed according to the packaging order.
Following materials may be stored in a packaging material store,
Unit cartons
Leaflets
Alu Foils
PVC Foils
Shippers etc.
Glass Bottles
Plastic Bottles
Droppers
Ampules
Vials etc.
Finished Good Store
Finished goods store is the area, as the name indicates, which is used for storage of finished medicinal products.
After packaging, products are stored in quarantine and when released, are delivered to the finished goods store. From the finished goods store, products are delivered to the market according to the demand.
Engineering Department
Engineering department is also an important department in the pharmaceutical industry that plays an important role in the smooth running of production operations.
There is a direct relationship between the production and engineering departments because production equipment also requires proper maintenance for smooth running.
The engineering department has many subsections. Some are as follows,
Electrical Department
Mechanical Department
Civil Department
HVAC Department
Steam and Compressed air Department
Water Supply Management
Engineering Store
Electrical Department
All the electrical work is supervised by this department. This department ensures uninterrupted electrical supply to the pharmaceutical industry. In case of any issue in electrical supply of an equipment or area,the solution is provided by this section.
Mechanical Department
This department deals with all the equipment and machines. In case of any machine breakdown, intimation is sent to the mechanical department and solution is provided by the trained staff of this department.
Civil Department
All civil work is supervised by this department.
HVAC Department
The HVAC department deals with the heating, ventilation and air conditioning system.This system is required for maintenance of temperature and humidity of all the manufacturing areas.
Differential pressure plays an important role in prevention of cross contamination and is also monitored by this department.
Steam and Compressed air Department
As the name indicates this department deals with steam and compressed air.The steam is required for many manufacturing activities especially for tablet coaters and dryers and its supply and maintenance is ensured by this department
Compressed air is also required for operation of many air driven equipment like blister machines etc and is supervised by this department.
Water Supply Management
In a pharmaceutical company thousands of litres of water is used per day in different processes.
For some general purposes raw water is used but for manufacturing processes following types of water are used,
RO water
Deionised Water
Water For Injection
For the production of high purity water, the ware treatment plants are installed like RO plant or distillation processor which produce high-quality water.
The supply of water and maintenance of water treatment plants is carried out by this supply department.
Engineering Store
Like warehouses which are used for storage of finished and packaging products, the engineering store is used to store all the spare parts and different components of machines and equipment.
The purpose of this store is to reduce the time period for purchasing machine parts in case of damage.
All the necessary parts are stored here in excess and in case of any breakdown, the part is taken from the store instead of taking it from the market.
The availability of different components in the engineering store results in a reduction of the response time for repairing and maintenance.
Regulatory Department
The regulatory department is one of the most important departments in the pharmaceutical industries and it is involved in dealing with all the legal and regulatory requirements. All the layouts of the industry are approved by regulatory authorities by the regulatory department.
The process of product registration is also handled by this department. If a pharmaceutical company wants to manufacture a product, first the company has to register that product.
For the registration process, the dossier is prepared by the regulatory department and is submitted to the legal bodies.
If a pharmaceutical company wants to export any medicinal product then this department takes registration from that country.
If a pharmaceutical company wants to add a new area or section in the plant, the layout approval process from government bodies is completed by this department.
EHS Department
EHS Stands for the environment, health and safety. EHS department in pharmaceutical industries is responsible for compliance in terms of safety, health and environment.
This department works for the protection of the environment and personnel as well.
For human health and safety regular medical check ups and use of PPE is ensured.
For the protection of the environment different measures are taken like the reduction of the emission of harmful chemicals and the treatment of wastewater before disposal.
HR Department
The HR or human resource department is an important department and is involved in the hiring of all workforce which is required for different departments of the pharma.
The HR department is also responsible for arranging different activities for the betterment of people working in the organization.
Marketing Department
Marketing department of pharmaceutical industries is involved in the marketing of its brands and products to increase sales.
Supply Chain Department
The supply chain department is responsible for purchasing materials and related supplies. All types of machines and equipment purchasing are also done by the supply chain department.
Accounting & Finance Department
The Accounting & Finance Department department is responsible for handling all the financial matters of the pharmaceutical industries.
Also Read
Introduction Of Hospital Pharmacy
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