• PDA TR 78

PDA TR 78

  • Technical Report No. 78 (TR 78) Particulate Matter in Oral Dosage Forms
  • Report / Survey by Parenteral Drug Association, 01/01/2018
  • Category: PDA

$325.00 $163.00

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.
PDF

All of our standards document are available in PDF (Portable Document Format), an electronic, downloadable format.You will be able to download the file in your account downloads.

Multi-User Access

After purchasing, you have the ability to assign each license to a specific user.

Printable

At any time, you are permitted to make printed copies for your and your members' reference use.

PDA TR 66

PDA TR 66

Technical Report No. 66, (TR 66) Application of Single-Use Systems in Pharmaceutical Manufacturing..

$163.00 $325.00

PDA TR 67

PDA TR 67

Technical Report No. 67, (TR 67) Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceu..

$163.00 $325.00

PDA TR 68

PDA TR 68

Technical Report No. 68, (TR 68) Risk-Based Approach for Prevention and Management of Drug Shortages..

$86.00 $171.00

PDA TR 54-4

PDA TR 54-4

Technical Report No. 54-4, (TR 54-4) Implementation of Quality Risk Management for Pharmaceutical an..

$163.00 $325.00