cGMP AND INDUSTRIAL MANAGEMENT

1. Masters of pharmacy, Pharmaceutical technology (Pharmaceutics)
Subject- Modern Pharmaceutics (MPH-103T)
Lesion no- 3, cGMP and industrial management By- Drx JAYESH M.RAJPUT
Points:-
1) CGMP:-
FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance
with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for
drugs contain minimum requirements for the methods, facilities, and controls used in
manufacturing, processing, and packing of a drug product. The regulations make sure that a
product is safe for use, and that it has the ingredients and strength it claims to have.
The approval process for new and generic drug marketing applications includes a review of the
manufacturer's compliance with the CGMPs. FDA assessors and investigators determine whether
the firm has the necessary facilities, equipment, and ability to manufacture the drug it intends to
market.

2. 2) Layout of buildings:-
Plant layout is a coordinated effort to achieve the final objective to integrate
machines, materials, and personnel for economic production. Involves location of
different departments and arrangement of machinery in each department.
Product or straight line layout:-
The arrangement of machines doing various operations in a line as one department.
Advantages:-
 Processing of work is quick and smooth
 Cost of handling is reduced using conveyers
 Manufacturing time can be reduced
 Floor space can be properly utilized

5. 3) Production management:-

7. 4) Inventory management:-

9. 5) Material handling and transportation:-

11. 6) Production and planning control:-
Production planning may be said to be a technique of forecasting ahead every step in the long process of production,
taking them at right time and in the right degree and trying to complete operations at the maximum efficiency.

13. 7) Sales forecasting:-

15. 8) Budget:-
A budget is a financial plan for a defined period of time, usually a year. It may also include planned sales
volumes and revenues, resource quantities, costs and expenses, assets, liabilities and cash flows.
Purpose:- budgeting tools provide a forecast of revenues and expenditures that is construct a model of how
a business might perform financially if certain strategies, events and plans are carried out. These tools
enable the actual financial operation of the business to be measured against the forecast.

16. 9) Cost control:-
Steps in cost control:-
1. Establishing norms:- the first step in cost control is to set norms or standards which may serve as
yardsticks for measuring performance. These standards are set on the basis of past performance adjusted
for changes in future and on the basis of studies conducted.
2. Comparison with actual:- the actual cost incurred are compared with established standard costs to know
the level of achievement. The variations are analyzed so as to arrive at the causes which are controllable.
3. Corrective action:- remedial measures are taken to avoid the recurrence of variation in future and for
revision of standards wherever necessary.
Importance of cost control:-
 Enables firm to achieving defined objective
 Proper utilization of firms resources
 Growth and survival of a firm
 Make the organization efficient

17. 10) Industrial and personal relationship:-

19. 11) Concept of total quality management:-
Total quality management- made up of the whole, degree of excellence a product or service
provides, act, art or manner of planning, controlling, directing. Therefore TQM, is the art of managing
the whole to achieve excellence.
 Produce quality work
 Focus on the customer
 Have a strategic approach to improvement
 Improve continuously
 Encourage mutual respect and teamwork

20. ______________________________________THE END______________________________