A general introduction about pharmacist, career prospect, job description and finally introduction of various national and international regulatory agency

5. SAMIA BASHAR
SHAMIUL BASHAR
RASHEDUL ISLAM
ESRAK JAHAN

7. Student ID
13121001

8.  Pharmacist
 Career prospect
 Role of pharmacist
 Job description: Production; QC; QA; R & D
 Regulatory agency
LEARNING OBJECTIVES
 National: PCB & DGDA
 International: WHO; USFDA; TGA; MHRA

9. “I am a Pharmacist
I am a specialist in medications
I am a custodian of medical information
I am a companion of the physician
I am a counselor to the patient
I am a guardian of public health
This is my calling
This is my pride.”
Pharmacist
 A pharmacist is one who is educated and
licensed to prepare and dispense drugs and to
provide drug and related information to the
public- An expert on drugs.

10. CAREER PROSPECT OF PHARMACIST

13. A job description typically is a narrative that
identifies a job title, a brief summary of the job, a
description of essential job tasks and duties, and all
or some of the following elements:
• What, where, when and how job tasks are done.
• What equipment, machines or tools are used?
JOB DESCRIPTION

14. Post: Production Executive
Job Description
1. Manufacturing of quality pharmaceutical
products complying with
2. Assist head of production & deputy manager,
production to improve
• cGMP
• Established production procedures and
• Schedule.
• Productivity and
• Decrease production cost.

15. 3. Maintain good relationship with
4. To solve processing problem with help of PD
and QA by implementing QMS tools.
5. Distribute work among workers and staff and
maintain their record.
Cont’d.
• QA & QC personnel,
• In-process control supervisors and
• Inventory planning supervisors.

16. Cont’d.
6. Prepare SOPs, training need analysis and
arranges various training program for
production department.
7. Prepare the daily and monthly reports and
arrange monthly reconciliation.
8. Apply all the provisions in respect of both
health and safety measures.

17. Student ID
13121002

18. Post: Executive, Research & Development
Job Description
1. Coordination of Technology Transfer and
Product lifecycle management activities.
2. Manufacturing Lab scale batches for
3. Compilation of Manufacturing documents
• Process improvement,
• Quality improvement &
• New sources development

19. 4. Manufacturing of scale-up /submission
/validation batches in coordination with other
department
5. Conducting validation activities
Cont’d.
• Manufacturing process
• New manufacturing methods and
• Testing methods

20. Cont’d.
6. Research related activities for new products like
7. Keeping proper records for all instruments
handling.
8. Calibration of Instruments, maintenance of Log
books.
• To prepare the formulation sheet,
• Manufacturing methods and
• Analytical methods

21. Post: Executive, Quality Assurance
Job Description
1. Batch release of manufactured products.
2. Generating all the required documents for
production i.e.,
3. Compilation of Batch History.
•Formulation Order (FO)
•Fill Label Pack Order (FLP)
•Batch Manufacturing Record (BMR),
•Batch Packing Record (BPR) and
•Standard Operating Procedures (SOPs)

22. 4. Reviewing and approving of quality
documentation.
5. Generating QA documents i.e., Quality
Assurance Profiles (QAPs), Certificate of
Analysis if finished Product (COA).
6. Generating, approving and implementing all
GMP related SOPs.
7. Controlling and distributing the SOPs of all
departments.
Cont’d.

23. 8. Maintaining records and relevant documents of
reworked products.
9. Participating in self inspections and regulatory
inspections.
10. Ensuring good relations and communications
with all members of the team and responding
politely.
Cont’d.

24. 11. Observing and complying with cGMP.
12. Observing and complying with company
Health and Safety Policies.
13. Ensuring required initial and continuous
training of production/ plant personnel.
14. Identifying the requirement of any significant
change required in relevant area of work and
informing head of department about it.
Cont’d.

25. Student ID
13121012

26. Carryout analytical activities of raw materials,
packing materials, finished products and to
ensure quality of product by implementing
guidelines of WHO, FDA, TGA, etc.
Perform in process Checking, BMR, BPR and
SOP's preparation and checking during
manufacturing of products.
Post: Executive, QC
Job Description

27. Participate in all qualification and validation
activities.
Ensure proper documentation of all quality
assurance related documents.
Ensure other activities like environment
control, water sanitation, HVAC system
validation, housekeeping, health & personnel
hygiene.
Cont’d.

28. Cont’d.
Sampling & Analysis of Raw Materials,
Packaging Materials, Finished Products and
Water.
Handling of all sophisticated QC instruments
like HPLC, GC, UV-VIS and others.
Calibration of all sophisticated QC equipment's.

29. Pharmacy Council of Bangladesh (PCB)
HISTORY
The Pharmacy Council of Bangladesh (PCB) is
an Organization under the Ministry of Health
and Family Welfare, Govt. of the People's
Republic of Bangladesh.
 It was established under the Pharmacy
Ordinance, Ordinance 1976.
Recently, 8 pharmacists are working in PCB

30. Structure of Pharmacy Council of
Bangladesh (PCB)
President secretary of ministry of health and family
President of council
Director general of health service
Directorate of drug administration
Dean faculty of pharmacy of Dhaka University
Professor of medicine
Professor of pharmacology of medicinal institute
One qualified pharmacist

31. Activities of the pharmacy council :
Approve examinations in pharmacy for
qualifying persons for registration as
pharmacists.
Prescribe the subjects in which approve
examinations shall be held.
Prescribe the condition and procedure for
admission of candidates.
Prescribe the equipments and facilities to be
made available to the students.

32. Cont’d.
To recognize degree or diploma in pharmacy for
the purpose of registration as pharmacist.
Undertake inspections of institutions which
conduct the course of study in pharmacy.
To register pharmacists and grant certificates of
registration.
Lay down the standard of teaching to be
maintained by the institutions

33. Student ID
13121030

34. DGDA (Directorate General of Drug
Administration)
Established 1976
Founder MD. Mustafizur Rahman
Headquarters
Mohakhali, Dhaka-1212,
Bangladesh

36. WHO (World Health Organization )
Established: 7 April 1948
Type: Specialised agency of the United Nations
Headquarters: Geneva, Switzerland
Head: Margaret Chan, Director General

38. USFDA (United States of Food and
Drug Administration)
Established June 30, 1906; 110 years ago
Jurisdiction
Federal government of the
United States
Headquarters
White Oak Campus, 10903
New Hampshire Avenue, Silver
Spring, Maryland20993

40. MHRA (Medicines and Healthcare
products Regulatory Agency)
Established 1 April 2003
Headquarters London, United Kingdom

42. TGA (Therapeutic Goods
Administration)
Established 1989
Founder Joshua Jacobs
Headquarters
White Oak Campus, 10903 New
136 Narrabundah Ln,
Symonston ACT 2609, Australia