useful for everyone interested in pharmaceutical microbiology, helpful for interviews, most asked question for candidates appearing interviews in pharmaceutical ,

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
• application 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: German bacteriologist/perfected
bacteriological techniques/ 1st 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
• Maintenance 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