PDA Revises Technical Report on Sterilized Products - - BioPharm International

ADVERTISEMENT

PDA Revises Technical Report on Sterilized Products



>

The Parenteral Drug Association has released a revision of Technical Report 30 (TR 30), Parametric Release of Pharmaceuticals and Medical Device Products TerminallySterilized by Moist Heat.

The revised report, originally published in 1999, provides current best practices of the sterile product release method and emphasizes the use of science-based approaches when developing a parametric release program for “pharmaceutical and medical device products terminally sterilized by moist heat.”

The original TR 30 outlined a sterility assurance release program that utilized effective control, monitoring, and documentation of a validated sterile product manufacturing process dependent on achievement of critical operational parameters instead of end product sterility testing. A group of international industry scientists, microbiologists, and engineers participated in the revision of TR 30.

PDA members can access TR 30 for free until June 15, 2012.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
Author Guidelines

Click here