1. Submitted by: -
Ram Mohan S.R.
1st M.Pharm
Pharmaceutical Quality Assurance
JSS college of pharmacy
Mysore
Facilitators: -
Dr. Vishal Kumar Gupta,
Asst Professor,
Dept. of Pharmaceutics,
JSS college of pharmacy,
Mysore.

2. A social unit of people that is structured and
managed to meet a need or to pursue collective
goles.
All organisations have a management structure that
determines relationships between the different
activities and the members and subdivided and
assigns roles responsibilities and authority to
carryout a different tasks

3. In establishing an organisational structure for the
manufacture and quality assurance of health and similar
products, the most generally accepted view is that there
should be two separate persons each with overall
responsibilities for production or for quality control,
neither of whom is responsible of other.
The EU GMP Guide states
The heads of production and quality control must
be independent of each other

5. Pharma production B. Pharm, M. pharm, Ph.D.
B. Sc, M. Sc, Ph.D.
Q.A/ Q.C. B. Pharm, M. Pharm, Ph.D.
B. Sc, M. Sc, Ph.D.
B. Sc, M. Sc, Ph.D.(analytical, organic,
bio and pharmaceutical chemistry and
microbiology)
Other areas P.G Diploma in packing technology.
B.E/M.E in Mech, E&E, Chem.
Qualified people in materials
management for stores and purchase
functions.
Management B. Com, M. Com, Ph.D.
B.B.M, M.B.A, Ph.D.
P.G.D.B.A.

6. A person is called a trained person when he has
appropriate knowledge, skill and attitude.
Knowledge Theoretical background expected in a
person regarding the job and principles of
GMP which may affect his area of work.
Skill Ability to use his theoretical knowledge to
perform a particular task.
Attitude It is a behavioural trait of a person who is
performing the task. Positive attitude is
needed towards performing assigned work.
Trained person is one, who has knowledge of his job and GMP, skill to
use his knowledge and a very very positive attitude

7.  Materials & construction
 Windows
 HVAC
 Infrastructure protection
 Entrances
 Lobby
 Auditorium/ training/ meeting rooms
 Loading dock
 Mailroom
 24/7 Manned control room

8. Receiving Warehouse
Drug
components
Packing
materials
Quality
control
Rejects
Approved
material
storage
Weighting
Dispensing MFG process In-process
storage
QC
Packing
Labeling Quarantine
Quality
control
Released
production
storage
Shipping
Rejects

9. Singnore & Jacbs; Good Design Practices for Good
Manufacturing Practices of Pharmaceutical Facilities, s/e,
page no- 50 & 59, Informa healthcare.
John sharp; Good Pharmaceutical Manufacturing process, 1/e
2005, page no- 24 to 26, CRC Press.
Monahor. A .Potdar; Pharmaceutical Quality Assurance, 2/e,
page no- 1.1 to 1.3, Nirali Prakashn
Chart from Google images