Page 5 - Quality control of pharmaceuticals (07-PA 704)

Pharmacopoeial standards: the product should meet the
pharmacopoeial standards of U.S.P.,B.P., Eu.P., J.P. (Japanese),
I.P. (international).

There are two applications for the term “Quality”:
1. Quality Control. 2. Quality Assurance.
The two terms are used interchangeable.

How to Establish Quality in Drug Product: Implement Total Quality
Management (T.Q.M.) which includes:

Quality Assurance (Q.A.), Good Manufacturing Practice (G.M.P.),
Quality Control(Q.C) and Auditing

I)Total Quality Management (T.Q.M.)(Good Quality Management
(G.Q.M.)):
It is the 3P quality management, and it is concerned with the quality of
personnel, processes and products.
Determine and implement the quality policy.
2. Establish quality in personnel, processes and products.
3. Provide personnel with training, life-long learning, leadership and one-
team approach.
4. Encourage new ideas and reward success.
5. Establish customer-focused organization.