med 18

ii. Abbreviated new drug applications (ANDAs)

iii. Abbreviated antibiotic drug applications (AADAs)

During the period after approval to change composition, manufacturing process,

manufacturing equipment, and manufacturing sites.

Level of Changes

There are three levels of changes as per the guidance document:

a. Level 1

Definition: These are the changes that are unlikely to have any impact, i.e. detectable

in nature on quality or performance of formulations.

b. Level 2

Definition: These are the changes that could have a significant impact on the quality

or performance of formulations.

c. Level 3

Definition: These are the changes that are likely to have a significant impact on the

quality or performance of formulations.

Type of Changes

There are mainly four types of changes

i. Change in manufacturing site

ii. Change in composition

iii. Change in manufacturing process

iv. Change in manufacturing equipment

Platform Technologies

A platform is a group of technology and acts as a base upon which various technologies,

applications, processes can be developed. For example, if we take the example of

computing system, then basic hardware and the operating system act as a platform on

which various programmes and applications can run. It is actually a combination of

hardware and software. There are different types of platforms. But all platforms have

two things in common:

a. They can be used for many candidates (that could be potential products)

b. Their establishment cost is very high and sometimes usage cost is also very

high.