Scope, roles and responsibilities of microbiologist in

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1. Scope, Roles And Responsibilities of Microbiologist In Pharmaceutical Industries BY: Nissim Ghimire

2. Key take away…… scopes of microbiology roles and responsibilities of a microbiologist a pplication of microbiological test methods in pharmaceutical testing sterilization and aseptic techniques major pharmaceutical contaminants: isolation/identification/preservation / destruction .

3. INTRODUCTION: What is microbiology? _____________________________ Microbiology is the study of the microscopic organisms that are either single celled ( unicellular ), cell-colony ( multicellular ) or acellular ( lacking cells ). their interaction with human and other organisms Pathogenesis , prevention and treatment of diseases caused by them. Uses of microbes in production of foods and beverages, useful drugs and probiotics . Branches of Microbiology: • Bacteriology • Virology • Mycology • and Parasitology

4. Some famous microbiologists: Antonie Phillips van Leeuwenhoek :Dutch businessman/ first microbiologist / father of microbiology and microscopy/ discovered microscope and observed bacteria Robert Koch : G erman bacteriologist/perfected bacteriological techniques/ 1 st cultivated anthrax bacilli (1876)- outside body using blood serum at body temperature/ introduced staining techniques/ pure culture methods/ tuberculosis bacillus (1882)/ cholera vibrio (1883)/ discovered spores/ first photogarphed bacteria (anthrax bacilli ), KOCH POSTULATES Louis Pasteur: introduced sterilization/developed steam sterilizer, hot air oven and autoclave/pasteurization/discovered process of attenuation / coined term vaccine/ vaccine for hydrophobia- rabies/ differing growth need of different bacteria.

5. Application and scopes of microbiology: microbiology Agriculture Industries Environment Dairy and food Medicine Investigation and epidemiology Beverage and alcohols Pharmaceuticals

6. Pharmaceutical microbiology An applied branch of microbiology which involves the study of microorganisms associated before, during and after the production of pharmaceuticals. Deals with the use and study of useful microbes on production of medicinal drugs/ presence of unwanted contaminants (in raw materials, finished products, packaging materials, testing and production environment)/their isolation/ identification and destruction.

7. Contribution of microbiology to pharmaceutical industries. The most important contribution is development of antibiotics (all antibiotics were initially the products of microbial metabolism), vaccines (the production of vaccines against bacterial diseases usually requires the growth of large amounts of bacteria and steroids hormones ( steroids can also be obtained from microorganism). Apart from drugs and bio products development, microbiology contribute towards quality control by preventing contamination of drugs, injectables , eye drops, nasal solutions, and inhalation products following pharmacopeial guidelines.

8. Role of Microbiologist in pharmaceutical industries: Quality control of water, raw materials, finished products (tablets, suspensions, ointments, sterile products) Quality control of production area Good documentation practices Good manufacturing practices etc Quality Control Officer/ Manager Other departments: Quality assurance Production Engineering and maintenance Research and development

9. Quality control : all processes designed to ensure that the products are fulfilling the quality requirements i.e. the results of laboratory analysis are consistent, comparable, accurate and within the specified limits. OR, ISO 9000 defines it as a part of quality management focused on fulfilling quality requirements Quality assurance : part of quality management focused on providing confidence that quality requirements will be fulfilled OR, A way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers.

10. Responsibilities of Microbiologist: Routine quality check of water: for coliforms and other pathogens like pseudomonas sps , staphylococcus sps etc): pour plate/ membrane filtration :Limit : Alert limit: 1 cfu /ml, Action Limit : 10 cfu /ml Calibration of equipments : As per SOP of respective equipments M aintenance of aseptic environments: Fumigation of working stations, environmental monitoring by bio-burden test, aseptic techniques (hand washing, proper use of mask, head caps and gowns, use of 70% IPA etc), dab test of personnel involved in production Routine microbial limit test of raw materials and finished products : As per SOP of respective raw materials and finished products.

11. Contd ….. Media preparation: for routine tests Growth Promotion Test of new batches of media purchased maintenance and preservation of bacterial mother cultures and subcultures Sterilization and their method validation Test method development and SOP preparation Sterility testing : eye drops, inject able drugs Proper documentation of daily water reports and other microbiological tests.

12. Materials to be tested : All raw materials like, sucrose, lactose, talcum powder, xanthum gum, gelatin etc. All finished products like tablets, capsules, suspensions and ointments.

13. Microbiological test methods: Sterility testing: for sterile drugs like: eyedrops and injectables . Microbial limit test : for all kind of oral drugs and superficial ointments and their raw materials. Bioburden testing: production rooms, Laminar air flows, sterility testing room, other test rooms, sampling room , sampling booths etc. Water testing: water used for production.

14. Major contaminants of pharmaceutical products: Those organisms isolated and identified in raw materials and finished products. Escherichia coli Staphylococcus aureus Pseudomonas aeruginosa Salmonella sps Shigella sps isolation/identification/preservation/ destruction: Isolation : Pure culture (plate culture at general purpose non inhibitory media like nutrient agar, soybean casein digest agar etc Identification: gram stain/ selective media depending upon colony characteristics: if gram positive cocci in clusters; indicative to Staphylococcus sps : Manitol salt agar/ biochemical tests : catalase / coagulase Preservation ( if necessary) : preserved at 2-8 ºC Destruction/ Disposal : Autoclaved at 121 ºC at 15 lbs pres sure for 15 minutes / autoclaved media with organisms buried into a pit.

15. Microbial limit test Growth promotion test Calibration of an incubator Water test

16. Mother culture and subculture preparation

17. Medicine Regulatory Authorities (MRA) SR.NO. Country Regulatory authority Full name 1 Nepal DDA Department of Drug Administration 2 USA USFDA United State Food and Drug Administration 3 UK MHRA Medicines and Healthcare Products Regulatory Agency 4 Australia TGA Therapeutic Good Administration 5 S. Africa MCC Medicine Control Council 6 Europe EMEA European Medicine Evaluation Agency 7 Srilanka SPC State Pharmaceutical Corporation responsible for audits and cross validation. Marketing authorisation / registration, Inspection, Import control, Licensing , Market control and Quality control,Medicines advertising and promotion,Clinical trials control

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