Detailed Study of MODERN PHARMACEUTICS, Pharmaceutics Department,

1. CGMP & Industrial
Management.
By: Vinayak Chavan
Sufiyan Kerur
1st Year M-Pharm Pharmaceutics Dept
Guided by : Dr C.C.Patil (HOD of Pharmaceutics Dept)
BLDEA’s SSM College of Pharmacy and Research Centre
Bijapur.

2. Content :
 Introduction
 Objectives
 Plant Layout.
 Services.
 Equipment’s.
 Production organization.
 Materials management.
 Handling and transportation.
 Inventory management and control.
 Production and planning control.
 Sales forecasting, budget and cost control.
 Industrial relationship.
 Concept of total quality management.

3. Introduction:
cGMP - Current Good Manufacturing Practice.
The cGMP regulations enforced by the FDA(Food and
Drug Administration).
cGMP’s provide for systems that assure proper design,
monitoring, and control of manufacturing processes and
facilities.

4. Components of cGMP :
 GMP is part of QA
 GMP’s main function is to produce quality products
consistently.
 GMP must meet legal requirement’s of country.
 GMP must meet both production and QC related issues.

5. ACTIVITES OF cGMP :
 cGMP expects that all the people should be trained.
 It provides complete guidelines on requirements of
facilities and equipment’s.
 cGMP talks about how you should control the quality of
materials at every stage.
 It also further talk about quality, production systems and
their control.

6. Objectives :
 Ensure that products are consistently manufactured and controlled to the
specified quality.
 Concerned with all aspects of production and quality control.
 In the manufacture of cosmetic products, overall control and monitoring.
 Ensure that the consumer receives products of specified quality.
 cGMP regulations assure the identify, strength, quality and purity of drug
products.
The quality of a product depends on the starting materials,
production and quality control processes, building, equipment and
personnel involved.

7. PLANT LAYOUT:
Plant Layout is a co-ordinated effort to achieve
the final objective to integrate machines,
materials, and personal for economic
production.
Plant layout involves location of different
departments and arrangement of machinery in
each department.

8. Types Of Plant Layout :
 Process layout or functional layout.
 Product or straight line layout.
 Process layout or functional layout :
Arrangement of machines of a particular class doing a particular process as
separate department.
Advantages :
• More effective supervision .
• Division of labour can be provided.
Disadvantages :
• May not be possible as a number of unit operations have to be performed .

9.  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.

10. Factors influencing plant layout :
 Basic managerial policies and decisions.
 Nature of plant location.
 Type of industry and process
 Intermittent Industries.
 Continuous Industries.
 Types of methods of production
 Job Production.
 Batch/Lot Production.
 Continues/Mass Production

11. SERVICES :
 Lighting,
 Ventilation,
 Air filtration,
 Air heating,
 Cooling,
 Plumbing,
 Washing and toilet facilities,
 Sanitation.
These are all services provide in cGMP.
(Current Good Manufacturing Practice)

12. EQUIPMENT :
• Equipment shall be of appropriate design, adequate size, and
suitably located to facilitate operations for its intended use and
for its cleaning and maintenance.
• Equipment shall be constructed so that surfaces that contact
components, in-process materials, or drug products shall not be
reactive, additive or absorptive.
• Equipment and utensils shall be cleaned, maintained, and as
appropriate for the nature of the drug, sanitized and/or sterilized
at appropriate intervals to prevent malfunctions or contamination.

13. Types of equipment :
• Automatic, mechanical, or electronic equipment or other types s
equipment. Including computers, or related systems that will
perform a function satisfactorily.
• Appropriate controls shall be exercised over computer or related
systems.
• Filters for liquid filtration used in the manufacture processing, or
packing of injectable drug products intended for human use shall
not release fibres into such products.

14. PRODUCTION MANAGEMENT :
Production may be defined as the conversion of inputs in to
out put through a transformation process.
Input: men, machines, materials, money, methods.
Output: goods produced-for manufacturing concern or
service rendered- for the service operation units as
banks, hospitals.
Production Management is viewed as a continuous process of
planning, organization and controlling.

15.  Planning :
• It includes all activities that established a course of action.
• It guides future decision making and involve product planning,
facility planning.
 Organizing :
• It includes all the activities that establish a structure of tasks and
authority.
• It determines the activities required to achieve the operations and
responsibility for carrying them out.
 Controlling :
• It includes all the activities that ensure that actual performance is
an accordance with the planned performance.

16. MATERIAL MANAGEMENT :
Definition :- It is an organizational concept which has the
authority & responsibility of all activities, principally
concerned with the flow of materials in the organization.
 Material management works continuously with production,
marketing, sales & quality control.
 It has the responsibility of determining the amount of inventory &
its accountability.
 It is concerned with planning, directing & controlling the kind,
amount, location, movement of the various flows of materials
used in & produced by a business enterprise.

17. Functional of Material management :
 Material planning & programming.
 Simplification, standardization & value analysis.
 Inventory control & management.
 Receiving of incoming materials.
 Storage, preservation & administration of materials.
 Production planning & scheduling.
 Disposing of rejects & obsolete materials.
 Improving operation efficiency through training.

18. Factors :
 Quality : It is defined as the suitability of an item to
accomplish the intended purpose.
 Quantity : The quantity is mainly based on the
calculation of Economic order quantity (EOQ).
 Price : Of materials are negotiated with the firms
based on certain procedures.
 Delivery date : are finalized based on the needs of
organization.

19. HANDLING & DISTRIBUTION:
 Warehousing
 Distribution
The conditions satisfied by the warehousing area are as follow:
 Good storage condition.
 Clean and dry.
 Acceptable temperature limit.
 Good sanitization.
 Separate sampling area.
 Fire Prevention.
 Properly labelled materials.

20.  Storage of drug products should be under appropriate conditions
of temperature, humidity, and light.
 A procedure whereby the oldest approved stock of a drug product
is distributed first. Deviation from this requirement is permitted if
such deviation is temporary and appropriate.
 A system by which the distribution of each lot of drug product can
be determined to facilitate its recall if necessary.

22. INVENTORY MANAGMENT:
Definition :
The ‘Inventory’ can be defined as stock of items (includes raw
materials, in process goods, finished goods, packaging, & other
spares) in order to meet an unexpected demand/distribution in the
future.
Or
Inventory is defined as an itemized list of goods with their
estimated worth, specifically, annual account of stock taken in any
business.

23. Objectives :
 To reduce dependence of one another.
 To enable each organisation schedule its independently of
another.
 To reduce material handling costs.
 Maximize customer service.
 Longer production runs.
 Flexibility in production scheduling.
 To avoid stock out and shortage.

24. Category :
 Production Inventory :
Special items manufactured to company specification.
 MRO Inventory :
Maintenance, repair & operating supplies which is consumed in
production process.
 In-Process Inventory :
Semi finished products found at various stages in the
production operation.
 Finished Goods Inventory :
Complete products ready for shipment.

25. Inventory costs :
 Cost factors must be considered while any decision regarding
inventories.
 Includes ordering costs, carrying cost, out of stock/shortage cost
and set up cost.
a. Ordering cost,
b. Carrying cost/Holding costs,
c. Out of stock/Storage cost,
d. Cost of item ,
e. Set up cost.

26. Techniques in Inventory Management :
 ABC Analysis
 VED Analysis
 EOQ Analysis
 Perpetual Inventory System
 Lead time
 Buffer Stock

27.  ABC Analysis :
• Always Better Control
• It is an inventory categorization method used for the analysis of
range of items that have different levels of significance and
should be controlled differently.
 VED analysis :
• This system is based on utility of the material.
• The different brands of the drug formulation is classified as:
V=VITAL ITEMS
E=ESSENTIAL ITEMS
D=DESIRABLE ITEMS

28.  EOQ Analysis :
• EOQ is the quantity of materials to be ordered at one time, which
minimizes the cost.
• The correct quantity to buy is the quantity at which the ordering
and inventory cost is maximum.
EOQ=√2AB
C
A - annual requirement
B - ordering cost
C – carrying cost

29.  Perpetual Inventory system :
• The method of recording the store balance after every receipt and
issue to facilitate checking and to prevent closing down for stock
taking.
• It comprises of :
1. Bin Card
2. Store Ledger
3. Continuous Stock Taking
 Lead Time :
• It is the time taken between the placing of order and receipt of
drugs to the department.
 Buffer Stock :
• It is used in emergency to meet the unseen demands.

30. PRODUCTION AND PLANNING CONTROL :
• There shall be written procedures for production and planning
control designed to assure that the drug products have the
identity, strength, quality, and purity they possess or are
represented to posses.
• Written production and process control procedures shall be
followed.
• The batch shall be formulated with the intent to provide not less
than 100% of the labelled or established amount of active
ingredient.

31. • Weighing, measuring, or subdividing operations for components shall be
adequately supervised . Each container of component dispensed to
manufacturing shall be examined by a second person.
• Actual yields and percentage of theoretical yield shall be determined at the
conclusion.
• All compounding and storage containers, processing lines and major
equipment used during the production of a batch of a drug shall be
properly identified.
• To assure batch uniformly and integrity of drug products, written
procedures shall be established ad followed that described the in process
controls, and tests, or examinations to be conducted.
• Written procedures shall be established and followed prescribing a system
for reprocessing batches that do not confirm to standards or specifications.

32. SALES FORECASTING :
Forecasting is the art of estimating future demand by
anticipating what buyers are likely to do under a given set of
future conditions.
A sales forecasting is a projection into the future of
expected demand given a stated set of environmental
conditions.

33. Short-term Forecasts :
• For periods up to 3 months ahead.
• For tactical matters.
• The general trend of sales is less important than short-term.
Medium-term Forecasts :
• For 1 year ahead.
• Of most importance in the area of business budgeting.
Long-term forecasts :
• For periods of 3 years and upwards.
• Needed mainly by financial accountants for long-term resource
implications.

34. BUDGETING :
• An organization needs to budget to ensure that
expenditure does not exceed planned income.
• The sales forecast is the starting point for
business planning activities. Taking the
medium-term sales forecast as the starting
point the budgets are allocated to
departments.
• Budges are a means of control.

35. Types Of Budgeting :
o Activity based
o Rolling
o Strategic Budgeting
o Zero Based Budgeting
Budget Determination :
• Departmental manager determines how the overall departmental
budget will be utilised in achieving the planned-for sales.
• The overall sales forecast is the basis for company plans, and the
basis for marketing plans in achieving those forecasted sales.
• The sales department budget is consequently a reflection of
marketing forthcoming expenditure in achieving those forecasted
sales.

36. Sales Budget :
• Is the total revenue expected from all products that are solid.
• Comes directly after the sales forecast.
• Is the starting point of the company budgeting procedure because
all other company activities are dependent upon sales and total
revenue anticipated from the various procedure that the company
sells.

37. INDUSTRIAL RELATION’S :
‘Industry’ refers to “any productive activity in which an individual
is (are) engaged”.
By ‘relations’ we mean “the relationships that exist within the
industry between the employer and his workmen”.
The Industrial relation relations also called labour -management.
Employee employers relations.
• The term industrial relations explains the relationship between
employees and management which stem directly or indirectly
from union-employer relationship.
• Industrial relations are the relationship between employees and
employers within the organization settings.

38. Parties of IR :
Importance :
• Uninterrupted production
• Reduction in Industrial Dispute
• High morale
• Reduced wastage
• Foster Industrial Peace
• Promote Industrial Democracy.
Employees
Employers
Government
Trade Union
Employer
Association
Court &
Tribunals
Industrial
Relations

39.  Role of Employers :
o Creating and sustaining employee motivation.
o Ensuring commitment from Employees.
 Role of Employees :
o To redress the bargaining advantages on one-on-one basis.
o To secure better terms and conditions for their members.
o To increase implementation of democratic way of decision making
at various levels.
 Role of State :
o Labour policies
o Labour laws
o Wage boards
o Industrial relations policy.

40. CONCEPT OF TOTAL QUALITY MANAGEMENT :
Total quality management(TQM) is a modern approach of the
management of the whole organization that emphasizes the
role of quality in meeting the needs and expectations of its
customers.
TQM stresses the need for the whole company to manage
quality at every stage of production and interaction with the
customer.

41. The quality here focuses in 3 perspectives:
• Quality of the products and services aligned with customer
specifications.
• Quality or amount of returns to satisfy the stake holder
needs.
• Quality of working conditions internal to the organisation.
TQM ensure that the management adopts a strategic overview
of the quality & focuses on prevention rather than inspection.

42. REFERENCES :
1) Overview of cGMP requirements. cGMP Regulations – 21
CFR 211
2) cGMP for Phase 1INDs Laurie P. Norwood. Deputy Director.
Division of Manufacturing and Product Quality. Office of
Compliance and biologics Quality.
3) How to write Standard Operating Procedures and work
Instruction”. David N.Muchemu, Creatspace, October 2010.
4) A primer good laboratory practice and current good
manufacturing practice Ludwig Huber Agilent Technologies.
5) FDA Food and Drug Administration. GMP Combination
Handbooks. 31 Aug 2008.
6) The Centre for Professional Advancement. Good
Manufacturing Practice. 2008. 1 Sep 2008.

43. Thank You.