specific process will consistently produce a product that meets its predetermined

specifications and quality attributes. A validated manufacturing process is one

that has been proven to do what it purports or is represented to do. The proof

of validation is obtained through collection and evaluation of data, preferably beginning

from the process development phase and continuing through the production

phase.

Validation necessarily includes process qualification (the qualification of materials,

equipment, systems, buildings, and personnel), but it also includes the control of the

entire processes for repeated batches or runs.

SUPAC guidelines mainly deal with three factors of changes (Fig. 3.1).

i. Level of changes

ii. Filing documentation

iii. Recommended chemistry, manufacturing and control tests/test documentation

28 Industrial Pharmacy II

3.4 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.

3.5 TYPE OF CHANGES

There are mainly four types of changes (Fig. 3.2)

i. Change in manufacturing site

ii. Change in composition

iii. Change in manufacturing process

iv. Change in manufacturing equipment

Fig. 3.1: Three factors of changes that SUPAC guidelines deal with

Fig. 3.2: Different components of SUPAC guidelines

SUPAC Guidelines and Platform Technology 29

A. Change in Composition and Components

This section deals with the changes in excipients in the drug product. It does not deal

with the changes in the amount of drug substance in the drug product.