Tablet Manufacturing in Pharmaceutical Company

1. Manufacturing of
Tablets

3. •Level 1: changes to parameters (e.g. mixing times,
operating speeds) within application/validation
ranges
•Level 2: changes to parameters (e.g. mixing times,
operating speeds) outside application/validation
ranges
•Level 3: change in the type of process, such as
from granulation technique to direct compression
of dry powder

4. Recommended documentation:
Level 1: one batch on long-term stability data
reported in annual report.
Level 2: stability, dissolution
Level 3: stability, dissolution, and BE study

5. Equipment is categorized according to
•Class: operating principle
•Subclass: design characterization

6. Equipment categorization
SUPAC equipment addenda:
◘ aid for considering equipment changes
◘ provides information on equipment
categorized according to class (operating
principle) and subclass (design characteristics)
◘ gives concise descriptions in context of other
classes/subclasses

8. FBD