This document discusses pharmaceutical industry development and cGMP requirements. It provides an overview of the pharmaceutical industry and legal requirements. It then summarizes cGMP requirements related to plant surroundings, general requirements, departmental areas including storage, production, quality control, sterile products areas, and ancillary areas. Finally, it discusses plant location and the importance of selecting an appropriate location considering factors like operating costs, physical plant design, and local market access.

1. PHARMACEUTICAL INDUSTRY
DEVELOPEMENT
PREPARED BY: PATEL JATIN B. GUIDED BY: DR. DINAL PATEL
M.PHARM (QA) [ ASSISTANT PROFESSER]
MQ004 FACULTY OF PHARMACY
DHARAMSINH DESAI UNIVERSITY

2. Overview
 The pharmaceutical industry discovers, develops, produces, and
markets drugs or pharmaceutical drugs for use as medications to be
administered (or self-administered) to patients, with the aim to cure
them, vaccinate them, or alleviate the symptoms.
 Pharmaceutical companies may deal in generic or brand medications
and medical devices.
 They are subject to a variety of laws and regulations that govern the
patenting, testing, safety, efficacy and marketing of drugs.

3. Legal requirement
 The cGMP requirements are described in the various guidelines
which deal mainly in the Following categories.
(a) Requirements related to surroundings.
(b) General requirements for pharmaceutical plants.
(c) Requirements related to various departmental areas in the plant.
(d) Requirements related to special products. e.g., sterile products.

4. (a) Requirements Related to Surroundings of the Plant
 Part I of schedule-M of Drugs and Cosmetics Act- 1940 states the requirements in
the following words-
 "The factory building(s) for manufacture of drugs shall be so situated and shall
have such measures as to avoid risk of contamination from external environment
including open sewage, drain, public lavatory or any factory which produces
disagreeable or obnoxious odour, fumes, excessive soot, dust, smoke, chemicals or
biological emissions.”
 Only Indian cGMP guidelines specifically talk about "surroundings" of
pharmaceutical plant.
 All other international guidelines talk in terms of "General Requirements" and
"different plant areas.”
 In the next section, we will review the "General Requirements" related to
pharmaceutical plants.

5. (b)General Requirements for Pharmaceutical Plants
 After reviewing the leading international cGMP guidelines, we can summarize the
same in the following points.
1. Pharmaceutical plants must be located, designed, constructed, adapted and
maintained to suit the operations to be carried out.
2. Their layouts and design must aim to minimize the risk of errors and permit
effective cleaning and maintenance, in order to avoid cross-contamination, built up of
dust or dirt and in general any adverse effect on the quality of the product and safety
of the personnel.
3. The Canadian guidelines are similar to above 1 and 2 but adds one point or
"Orderliness" in the plant and specifically talks about preventing contamination of
drug and addition of extraneous materials to the drug.
 It also talks about regular maintenance of the plants to prevent deterioration of
the premises and finally says that the "Ultimate objective of all endeavours is
product quality."

6. (c) Regulatory Related To Various Departmental Areas
 The regulatory requirements related to various departmental areas
cover following points.
 The regulatory guidelines cover requirements related to the
following departments, viz.,
(i) Storage and weighing areas
(ii) Production areas
(iii) Q.C areas
(iv) Sterile-products areas
(v) Ancillary areas

7. (i) Storage and Weighing Areas
 Storage area should be of sufficient capacity to allow orderly storage of the various
categories of materials and product;
1. starting and packaging material,
2. intermediates, bulk and finished products,
3. products in quarantine and released, rejected, returned or recalled products.
 Storage areas should be designed or adapted to ensure good storage conditions.
 In particular, they should be clean and dry and maintained within acceptable
temperature limits.
 Where special storage condition are required (temp and humidity) there should be
provided, checked and monitored.

8. Weighing Areas
 The weighing of starting materials and the estimation of yields by
weighing should be usually carried out in separate weighing areas
designed for that use, e.g., with provision for dust control.

9. (ii) Production Areas
 In order to minimize the risk of a serious medical hazard due to cross-
contamination, dedicated and self contained facilities must be available for the
production particular pharmaceutical products, such as highly of sensitizing
materials.
 e.g., (penicillin) or biological preparations (e.g., live micro organisms) the
production of certain other products such as some
1. antibiotics,
2. hormones,
3. cyto toxic substances,
4. highly active pharmaceutical products should not be conducted in the same facilities.

10. (iii) Quality Control Areas
 Quality control laboratories should be separated from production areas.
 Areas where biological, micro-biological or radioisotope tests are employed
should be separated from each other.
 Control laboratories should be designed to suit the operations to be carried out in
them.
 Sufficient space should be given to avoid mix- ups and cross contamination.
 There should be adequate suitable storage space for samples, reference standards
(if necessary, with cooling) and records.
 The design of the laboratories should take into account the suitability of
construction materials, prevention of fumes, and ventilation.

11.  Separate air-handling units and other provisions are needed for biological, micro-
biological and radioisotope laboratories.
 A separate room may be needed for instruments to protect them against electrical
interference, vibrations, contact with excessive moisture and other external factors
or where it is necessary to isolate the instruments.
 Quality control labs should consider following area
1. Office for Q.C. /Q.A. staff
2. Library and conference room
3. Stores for glassware, chemicals, microbial media, stationary etc.
4. Control samples room.
5. Records room.
6. Strong room for storage of government original documents like various licenses etc.
7. Change rooms for Q.C. /Q.A. staff with wash facility.
8. Any other areas

12. (iv)Sterile Products Area
 In addition to the general requirements for the facilities, sterile-products
manufacturing areas should give attention to following points:
 All premises should as far as possible designed to avoid the unnecessary entry of
supervisory or control personnel.
 Grade “B” areas should be designed so that all operations can be observed from
outside.
 In clean areas all exposed surfaces should be smooth, impervious and unbroken in
order to minimize the shedding or accumulation of particles or micro-organisms
and to permit the repeated application of cleaning agents and disinfectants used.

13.  To reduce the accumulation of dust and to facilitate cleaning there should be no
uncleanable recesses and a minimum of projecting performed monitoring should
be freque using methods such as
 Settle plates, volumetric air and surface sampling (e... swab or contact plates)
Sampling methods used in operation should not interfere with zone protection.
 Results from monitoring should be considered when reviewing batch
documentation for finished product release.
 Surfaces and personnel should be monitored after critical operations.
 Additional microbiological monitoring is also required outside production
operations e.g.. after validation of systems, cleaning and sanitation.

15. (v) Ancillary Area
a. Rest, refreshment rooms and smoking areas.
b. Change rooms and storing of linen, toilets and washrooms.
c. Maintenance workshops.
d. Animal houses.
Now let us briefly look at the regulatory requirements regarding the
above mentioned departmental areas.

16. (a) Rest, Refreshment Rooms and Smoking
Areas:
 Rest and refreshment rooms should be separate from other areas.
Refreshment areas may be declared as smoking areas.
 Refreshment room are part of dining hall.
 Rest room are generally not provided in the plant however such
rooms should be provided.
 These areas should be used for resting after lunch/dinner till the
employee finish their lunch break.

17. (b) Change Rooms and Storing of Linen:
 Facilities for changing and storing of clothes and for washing and
toilet purposes should be easily accessible and appropriate for the
number of users.
 (Also ref. to factory's Act requirements) Toilets should not
communicate directly with production or storage area.
 These areas should be well ventilated.

18. (c) Maintenance Work Shops:
 Maintenance work shops should if possible be separated from
production areas, whenever parts and tools are stored in the
production areas these should be kept in rooms or lockers reserved
for that use.
(d) Animal Houses:
 Animal houses should be well isolated from other areas, with
separate entrance (animal access) and air handling facilities.

19. Plant Location
 Plant location means the establishment of an industry at a particular
place.
 The performance of an enterprise is considerably affected by its
location.
 The selection of site for any enterprise mainly depends on its size
and nature.
 Sometimes, The nature of the product itself suggest some suitable
location.

20. Plant Location
1. Small scale industry
 It mainly selects the site where in accordance with its capacity; the
local market for the product is available.
 It can easily be shifted to other place, when there is any change in the
market.
2. Large scale industries
 Where huge amount of investment has already been done the selection
of proper site is very important.

21. Importance of Plant Location
The selection of appropriate location is important due to the following reasons:--
 Location of plant partially determines operating and capital costs. It determines the
nature of investment costs to be incurred and also the levels of operating costs.
 Location fixes some of the physical factors of the overall plant designs. e.g.
heating and ventilation requirements, storage capacity of raw material taking into
consideration their local availability, transportation need for raw materials and
finished goods, power needs ,cost of labours, taxes, land construction, fuel, etc.
 Each prospective location implies a news allocation of capacity to respective
market area.
 Government sometimes plays an important role in the choice of location keeping
in view the national benefits.

22. FACTORS RESPONSIBLE FOR THE PLANT
LOCATION CHOICES
The choices of the plant location are based on the following factors: ---
1. Availability of Raw material:
 An ideal location is one where the main raw material required to manufacture
the product is adequately available.
 This will ensure regular supply of the material and will reduce the
transportation costs.

23. 2. Nearness to the potential market:
 Marketing of finished goods efficiently is an important function of an enterprise. If
the plant is located near the market, then the management can keep close touch with
their changes in market environment and formulate its production policies
accordingly. Moreover, the transportation and other overhead expenses are reduced.
3. Location should be near to source of operating power:
 In some industries, continuous and adequate power supply is needed.
 There are certain industries for which cheap electricity may be very important. In
such situation, location of the plant near to the hydel-power situation will provide
cheap electricity.

24. 4. Supply of labour:
 Labour is one of the most important inputs in any industrial enterprise. There should
be regular and cheap supply of labour, specifically the unskilled labour. If there is
adequate supply of local labour near the plant, then naturally it will be available at
cheaper rates.
5. Transport and communication facilities:
 Transport is very important for bringing raw materials, fuel from different places,
marketing of finished products etc. The region well connected with rail, road, water
and air transport system is considered to be more appropriate for the location of the
plants.
 Similarly good communication facilities, such as, postal and telecommunication links
are of great significance towards the success of an enterprise. Regions with good
communication system should be given priority for the selection of the sites.Similarly,
industries producing goods for exports may be located near ports or airports.

25. 6. Suitability of land and climate:
 Sub-soil of the location should be able to support the load likely to be placed on it.
Similarly, climatic conditions viz humidity, temperature and other atmospheric conditions
should be favorable for the plant. For the example, humid atmosphere is not suitable for
the formation of pharmaceuticals.
7. Integration with other group of companies:
 New enterprise owned or operated by a single group of companies should be so located
that its work can be integrated with the work of the associated establishments.
8. Availability of housing, other amenities and services:
 Good housing facility, adequate shopping centre, theatres, cinema halls, restaurants,
local transport facilities, rail services and sufficient availability of gas, water supply,
drainage, disposal of waste, can easily attract good staff.

26. 9. Local building and planning regulations:
 Proposed location should not be infringe local regulations and bye-laws. A
discussion with survey department of the local authority is most desirable.
Laws for the construction of buildings, local taxes etc. should be taken into
consideration for the selection of site.
10. Safety requirements:
 Industries likely to cause pollution or processes explosives in nature should be
located in remote areas.
11. Miscellaneous considerations:
 The consideration like low interest on loans, special grants, low rentals, attitude
of residents, towards the industry, living standards etc. helps in locating in the
site of plants.

27. Selection of Site
 Once an appropriate area is chosen for certain plant, next step is
location analysis to choose suitable site in that area.
 The choice of site is important both for objective and subjective
reasons.

28. The following points should be kept in mind for the selection of the site:---
1. It should be well connected with rail, road and river transports.
2. There should be efficient sewage system for the disposal of water and
waste materials.
3. The surroundings should be good and peaceful.
4. The sub-soil should be capable of bearing the load of the building plant
and equipment.
5. There should be sufficient land to meet the present as well as the future
space requirements of the plant. There should be provision for the parking
of transport and sufficient space for residential accommodation for staff
and labour.

30. Site can be selected both in urban or rural areas.
1. Urban area
 It can provide better transport and communication system with sufficient labour
supply. There can also be adequate security arrangements as well as other social
services like medical, entertainment, restaurants, educational etc. But in urban area,
cost of land and labour wages are likely to be on higher side.
2. Rural area
 It can provide cheaper land and labour with scope for further expansion. The local
taxes and expenditure on other amenities is likely to be very low. The main
shortcomings of rural plant site lies in scarcity of skilled labour, good shopping
complexes, entertainment facilities, school and colleges and other amenities. In
general, rural location is good for large plants.

31. Thank you