Basic questions - FDA.COMs Community Forums

Username

Post: Basic questions (Topic#4308)

Rocky Bell
Beginner
Posts: 7

08-03-09 04:19 PM - Post#5605

Ilearn on some forum & thought of asking, these are very basic queries like-

1. What is the basis of specifying number of sample units for different inprocess tests in pharmacopoeia like-
Weight variation- 20 tablets
Distintegration Test- 6 tablets
Friability -20 tabs or 6.5g etc.

2. All the products do not have requirement for dissolution, What kind of products do require dissolution?Any specific property of formulation or drugs?

3. What is the origin of usage of 90 mm plate (specific size) for Settle plate and 55 mm plate for Contact plate method for micro monitoring?

4. Is recovery study for microbial monitoring required in cleaning validation?

5.Is any guideline exist for blend uniformity analysis in process validation?

Rocky Bell