DOCUMENTATION

The documentation is the essential part of pilot-plant scale-up process because of the

following reasons:

i. Act as a source of data for large-scale production

ii. Helps in the transfer of technology at pilot-plant scale-up stage only

iii. Helps in analysing the problems that can be there at the commercial stage

iv. Provides an efficient way of sharing knowledge

v. Supports the maintenance and enhancement of the system

vi. Facilitates internal communication between departments

vii. Helps in review procedure at any time and at any scale of production of the

concerned product

viii. Good documentation helps personnel by giving them sorted documents. They

only have to deal with the content relevant to them which saves time and increase

the efficiency level

ix. Provides a clear description of the responsibilities of different departments/

personnel

x. Provides data related to other activities like any updates, amendments, circulars,

notices, etc during scale-up or pilot-plant study

xi. Helps in identification of changes and reason for those changes during the process

xii. Helps in consulting previous historic versions where relevant

SUPAC GUIDELINES

The batch size of the product under development process at laboratory-scale is very

small. It increases gradually as development process develops. This is known as scaleup. During the scale-up of the product, the product gets market approval from

regulatory authorities. But there may be some changes in the product after the approval.

These are known as SUPAC, i.e. Scale-up Post Approval Changes. These changes are

46 Industrial Pharmacy II

related to composition, manufacturing process, manufacturing equipment and

manufacturing sites. These changes have to be approved before implementation. So,

to guide the industries regarding SUPAC, USFDA issues various guidance documents

such as:

i. SUPAC-IR (immediate release solid oral dosage form)

ii. SUPAC-MR (for modifies release solid oral dosage form)

iii. SUPAC-SS (for non-sterile semisolid dosage forms)

3.1 PURPOSE OF GUIDANCE

1. The guidance provides recommendations to sponsors of:

i. New drug applications (NDAs)