PDA TR 78

PDA Technical Report No. 78, Particulate Matter in Oral Dosage Forms documents the current practices used by manufacturers of drug products, active pharmaceutical ingredients, excipients, and packaging/primary containers to control, inspect, sample, and test intrinsic and extrinsic particulate matter in oral dosage forms. The scope of this Technical Report includes current practices of monitoring for particulates, as well as recent quality, clinical relevance, and regulatory experience in oral dosage forms.

Published:

01/01/2018

ISBN(s):

9781945584008

Number of Pages:

30

File Size:

1 file , 850 KB

Product Code(s):

01078