Submitted by: -Ram Mohan S.R.

1st M.Pharm

Pharmaceutical Quality AssuranceJSS college of pharmacy

Mysore

Facilitators: -Dr. Vishal Kumar Gupta,Asst Professor,Dept. of Pharmaceutics,JSS college of pharmacy,Mysore.

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

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

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.

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

Materials & construction

Windows

HVAC

Infrastructure protection

Entrances

Lobby

Auditorium/ training/ meeting rooms

Loading dock

Mailroom

24/7 Manned control room

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

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