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PDA TR 78

Technical Report No. 78 (TR 78) Particulate Matter in Oral Dosage Forms

Report / Survey by Parenteral Drug Association , 01/01/2018

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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.
 

Product Details

Published:
01/01/2018
ISBN(s):
9781945584008
Number of Pages:
30
File Size:
1 file , 850 KB
Product Code(s):
01078