PHARMACEUTICAL INDUSTRY

1. PHARMACEUTICAL INDUSTRY Prepared by A.Erenşah Kaya Hande Kartal Merve Maçin Züleyha Atlay

2. OUTLINE • Description of Pharmaceutical Industry - Hıstory of Pharmaceutical Industry in Turkey - Acts and Standards

3. Description of Industry The Pharmaceutical Industry provides medicines to be used as medications for humans and animals. The Pharmaceutical Industry includes: • Manufacture • Extraction • Processing • Purification • Packaging of chemicals to be used as medications.

4. Description of Industry

5. The Main Pharmeceutical Groups The main groups that are manufactured are: • Proprietary ethical products ( prescription-only medicines POM) • General ethical products • Over-the counter (OTC) products

6. The Major Manufactured Groups The products are available as : • tablets • capsules • liquids • ointments • aerosols

7. The groups include: Antibiotics such as penicillin Other synthetic drugs Vitamins Synthetic hormons Glandular products Vaccines and sera Drugs of vegatable origin The Major Manufactured Groups

8. History of Pharmaceutical Industry In Turkey 1928-1950: Production of Pharmaceutical preparations done at laboratories 1952: The start of fabrication period of the Turkish Pharmaceuticals industry 1984-1990: Investments of foreign capital companies increased. Foreign Capitals entered into Turkish Market Today: There are 300 entities operating in Turkey. 43 manufacturing facilities, 14 of them are multinational firms.

9. The most important international pharmaceutical companies are: Bayer (Germany) GlaxoSmithKline (UK) Aventis (US) Roche(Switzerland) Sanofi (France) Novartis( Switzerland) History of Pharmaceutical Industry In Turkey

10. Turkish Manufacturers: EIS Eczacıbaşı Abdi İbrahim Fako İlsan İltaş Mustafa Nevzat İbrahim Ethem Bilim History of Pharmaceutical Industry In Turkey

11. The Principal Manufacturing Step Steps are: • Preparation of process intermediates • Introduction of functional groups • Coupling and esterification • Seperation processes such as washing and stripping • Purifications of the final product

12. Additional Product Preparation Steps are: • Granulation • Drying • Tablet pressing • Printing • Coating • Filling and packaging

13. Industrial Pollution • According to manufacturing steps, air emissions, liquid effluents ( wastewater) and solid wastes may be generated. • To reduce the wastes, we should reuse and recycle. Remaning wastes should be treated according to characteristic.

14. ACTS & STANDARDS • The Production and marketing of medicines must be authorized by The Health Ministry. • Treated wastewater should be discharged; According to The Control of Water Pollution Management ( 04.09.1998)

15. ACTS & STANDARDS • The Control of Water Pollution Management Discharge Standards For Pharmaceutical

17. TABLES FROM EPA

21. Processes In Pharmaceutical Industry • Goods Receiving • Laboratory • Preparation • Formulation • Finishing • Packaging • Warehouse & Distrubituon

22. Goods receiving • pharmaceuticals are stored, • either in the form of raw materials or packaging. • It’s vital to optimally manage these materials, protect them from end to end, • and systematically document them.

23. Goods receiving

24. Laboratory • laboratory management means proven solutions for access control, • building automation, • and risk management to ensure constant • and secure environmental conditions in lab.

25. Laboratory

26. Research & Development • Including several fields; • chemical research, • microbiological research, • pharmacological research Produces different waste types

27. Preparation • The production process, • for example, • depends on being able to process the correct amounts of the right raw materials at the right time

28. Preparation

29. Chemical Synthesis • Most drugs production • Chemical synthesis process manufacturing pharmaceuticals using • organic and • inorganic chemical reactions

30. Typical manufacturing plant, • one or more batch reactor vessels series of reaction, • separation and purification steps desired end product

31. In drug manufacturing plant, • reaction vessels • Equipments arranged into separate

32. Solvents to dissolve • Gaseous • Solid • Viscous reactants To bring all the reactants close molecular also serve to transmit heat to or from the reacting molecules.

33. Some solvents also  control the reaction temperature. • common practice in a batch-type synthesis

34. Natural Product Extraction • Many materials as pharmaceuticals • derived from such natural sources; • the roots, • leaves of plants, • animal glands, • and parasitic fungi

35. numerous and diverse pharmaceutical applications, ranging from • Tranquilizers and allergy-relief medications • Insulin and • Morphine • Blood fractionation plasma and its derivatives.

36. Despite diversity, • all extractive pharmaceuticals  common characteristic: • Too complex to synthesize commercially • either very large molecules to synthesize

37. Extraction  expensive manufacturing process • requires collecting and processing large • volumes of specialized plant • animal matter • to produce small quantities of products.

38. Fermentation • Most antibiotics ,steroids and vitamin B fermentation process, • two major steps: • inoculum and seed preparation • fermentation, followed by crude product recovery and purification

39. Sterile inoculum preparation begins • in the lab with • carefully maintained population of a microbial strain. • A few cells this culture matured into a dense suspension through a series of test tubes, agar slants, and shaker flasks.

40. For further propagation, the cells are then transferred to • Seed tanklike a full scale fermenter and is • Designed for maximum cell growth • Final seed tank volume occupies • from 1 to 20% of the volume used in full scale production.

41. Formulation

42. Formulation • Pharmaceutical formulation is the preparation of dosage forms such as • Tablets • Capsules • Liquids • Parenterals • Creams • Ointments

45. Finishing

46. Finishing • The best way to reliably drug finishing • efficiency, • quality and transparency • is through consistent, • end-to-end automation solutions • can seamlessly integrate • components from a wide range of manufacturers.

47. Packaging

48. Warehouse & Distribution

49. Warehouse & Distribution • They’re efficient way stations on the road from manufacturer to consumer, • using the most precise and • up-to-date climate control, • automation, and • building security.

50. TypicalWasteStreams • The pharmaceutical industry is also highly diverse. • With this diversity of processes comes a similarly diverse set of waste streams.