In ancient times people use plants or animals matter to cure some sort of ailment or diseases by using home remedies. But now day’s medicine manufacturing is performed by chemical processing. Scientists first finds chemicals in plants or animals with their years of research and knowledge, then isolate these chemicals and try to make artificial chemical like original source chemical taken from plant or animals. After getting succeeded in making artificial synthetic chemical that cure targeted ailment or diseases, scientists start making medicines.
Now question is what a medicine contains? So medicines contain active drug called API (Active Pharmaceutical Ingredients) and excipient. API is active drug in any medicine which has therapeutic action to cure targeted ailment or diseases or disorder. While excipient is the non-active ingredient to support and enhance activity of drug product.
Where these medicines are manufactured?
Medicines are manufactured in Pharmaceutical manufacturing companies like Cipla, Glenmark, Lupin, Wockhardt, Alembic, Zydus, Mylan etc. First drug API is manufactured in API processing plants and then medicines are manufactured in Formulation plants by using API drugs and excipients. Medicines are manufactured in different dosage forms like OSD (Oral Solid Dosage) tables, capsules, Liquid Syrups, Injectable etc. Means you get medicines prescribed by your doctor in forms like tablets, capsules, liquid syrups, injections. These medicines are manufactured under GMP (Good Manufacturing Practices) controlled environment. During medicines manufacturing temperature, humidity and air pressure is maintained by AHU (Air Handling Unit) to provide controlled environment and also to prevent cross contamination.
API Manufacturing Plant
API plants have different departments for dedicated function like Warehouse Department for storage receive, dispensing and dispatch of materials. Production Department or API Plant where batch (Batch is a specific quantity of a drug or other material that is intended to have a uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacturing.) processing happen, means chemical reactions are performed as per Batch Records and SOPs (Standard Operating Procedure) in chemical reactors.
Quality Control Department or QC Lab where testing of samples is performed. QC Sampling is a process of abstraction of a portion of material from a lot or a batch in such a way that the withdrawn sample is representative of that whole lot or batch. QC person perform testing by taking samples at different stages of API manufacturing. Quality Assurance Department for taking assurance of quality of manufactured API during processing. HR, Admin, IT, Finance, RA, CQA are other supporting departments.
Formulation plants also have different departments just like API manufacturing plants. Warehouse for storage, control, dispense and dispatch of materials and products. Production Department where medicines are produced, Different type of machines are used in production plants to make medicines like Isolators, Blending machine, compression machine, coating machine, granulation machine, capsule filing machine, inspection machine etc. are used to make medicines.
Packing Department where packaging of medicines is performed with the help of different machines. Blister machine, Bottle filling Counter machine, checkweigher, Unscrumbler, Desiccant Sachet inserter, Cottoner, Capper Sealer, Labeller, CAM cartonator, Printer, Shipper Sealer are some machine used in packing department.
Quality Control Department or QC Lab where testing of samples is performed. QC person take sample during batch processing from different stages of manufacturing and analyse these sample in chemical labs using HPLC, GC, distillation, chromatography, titration and many more advance testing methods. Quality Assurance Department for taking assurance of quality of manufactured medicines. Safety Department to take care about safety of property building and peoples working in pharma industry
Drug development: journey of a Medicine manufacturing
During manufacturing medicines goes through different stages to become finished goods. First API and Excipient is dispensed by warehouse to production. Then these are mixed filtered and processed to produce intermediate product (A partly processed material, which undergoes further processing before it becomes a finished product). Then this intermediate product is processed further to produce finished product.
Finished product is a product that has completed all stages of manufacturing, and now this finish product is ready for packing. Now packing department perform packaging of finish product into finished goods. Finished goods are products that has completed all packing stages and packed into the final pack, as a result now ready for dispatch.
Dispatched finished goods are now become medicine after several processing testing manufacturing and packaging stages. Manufacturing of medicines is regulated by Regulatory Bodies around the world like USFDA (Unites States Food and Drug Administration from United States), WHO (World Health Organization), MHRA (Medicines and Healthcare Products Regulatory Agency from United Kingdom), CDSCO (Central Drug Standard Control Organization from India), TGA (Therapeutic Goods Administration from Australia), TPD (Therapeutic Product Directorate from Canada), EMA (European Medicines Agency from Europe) etc. Every manufactured medicine has manufacturing date, expiry date and shelf life. So now we understand these terms more clearly means what is manufacturing date, expiry date and shelf life.
What is Manufacturing Date?
Manufacturing date of the batch is the date on which actual batch activity is started so dispensing is always the first activity during any batch processing. So date of dispensing is considered as the manufacturing date.
What is Expiry Date?
Expiry date is the date till which a drug product is expected to remain within its approved specification. Or simply it is the date up to which the medicine is useful for its intended action.
What is Shelf Life?
Shelf life of medicine is a period of time during which a medicinal product or medicine, when stored properly under environments defined on the label is expected to comply with established specification. Or simply it is the time period up to which the medicine is useful for its intended action.
So today we learn what is medicine and how it is manufactured at Chemistry Notes Info. In upcoming posts we learn more about medicine manufacturing. Do you know what is GMP and why it is necessary during medicine manufacturing.
Books to learn how pharma drug medicines are manufactured
- cGMP Current Good Manufacturing Practices for Pharmaceuticals, 2nd Edition
- Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products
- An Unfinished Agenda: My Life in the Pharmaceuticals Industry