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
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).
iii. Recommended chemistry, manufacturing and control tests/test documentation
There are three levels of changes as per the guidance document
Definition: These are the changes that are unlikely to have any impact, i.e. detectable
in nature on quality or performance of formulations.
Definition: These are the changes that could have a significant impact on the quality
or performance of formulations.
Definition: These are the changes that are likely to have a significant impact on the
quality or performance of formulations.
There are mainly four types of changes (Fig. 3.2)
i. Change in manufacturing site
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.
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