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A plant can be defined as a place where 5Ms like money, material, method, man and

machines are brought together for the manufacturing of products. A plant contains all

assets of business like land, money, equipment, employees, etc. In the pharmaceutical

industry a plant is used as a synonym for manufacturing plant where drug/medical

devices/cosmetics manufacturing is going on. Various guidelines by regulatory

authorities have to be followed by the manufacturer before setting up a manufacturing

plant in the pharmaceutical industry. There are several types of manufacturing plants

in the pharma industry like API manufacturing plant, formulation manufacturing plant,

contract manufacturing plant, etc.

PILOT-PLANT

Pilot-plant can be defined as “the manufacture of either drug or drug product by a

procedure fully representative of and stimulating that used for full manufacturing

scale.” A pilot-plant is a part of the pharmaceutical industry where a lab-scale formula

is transformed into a viable product by the development of the liable and practical

procedure of manufacture.

Reasons for Conducting Pilot-Plant Studies

i. Evaluation of results

ii. Determination of qualitative and quantitative details of a product

iii. Determination of waste products

iv. Decision making

v. Need to make supplies

Objectives of Pilot-Plant

i. To attempt the procedure on a model of a proposed plant before spending the

substantial whole of cash on a production unit.

ii. Examination of the procedure to decide its capacity to withstand batch scale and

process alteration.

iii. Validation and evaluation for process and supplies.

iv. To detect unforeseen problems during commercialised production.

v. To make available master manufacturing formula

vi. To identify the critical control points of a process

vii. To avoid scale-up problems

Pilot-Plant operations

A pilot-plant operation includes a series of operational aspects. These are as follows:

1. Validation

2. Training

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