Low prices! Originals & Translations! Save your budget and time!
ONLINENORMS: Online Standards Store
Click View Shopping Cart
  1. Home
  2. PDA
  3. PDA TR 54-2 PDF

PDA TR 54-2 PDF

PDA TR 54-2 PDF

Name:
PDA TR 54-2 PDF

Published Date:
06/01/2013

Status:
Active

Description:

Technical Report No. 54-2 (TR 54-2) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operation: Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling

Publisher:
Parenteral Drug Association

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$97.5
Need Help?
The first Annex to Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides specific case studies on how to apply quality risk management (QRM) to pharmaceutical manufacturing, specifically packaging and labeling operations. This report is intended to align with ICH Q9 and is one in a series of similar documents that provide additional examples of how to apply risk management tools across the product supply chain. Technical Report No. 54-2 was drafted by an all-volunteer team of experts representing companies like Merck, Amgen and Genentech.
File Size : 1 file , 1.7 MB
ISBN(s) : 9780939459551
Number of Pages : 63
Product Code(s) : 01054-2
Published : 06/01/2013

History

Related products

PDA TR 3
PDA TR 3
Published Date: 07/01/2013
Technical Report No. 3, Revised 2013 (TR 3) Validation of Dry Heat Processes Used for Depyrogenation and Sterilization
$97.5
PDA TR 48
PDA TR 48
Published Date: 05/01/2010
Technical Report No. 48 (TR 48) Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance
$97.5
PDA TR 63
PDA TR 63
Published Date: 09/01/2013
Technical Report No. 63 (TR 63) Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials
$97.5
PDA TR 83
PDA TR 83
Published Date: 2019
Technical Report No. 83 (TR 83) Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response
$97.5

Best-Selling Products

NEBB BET PUBLICATION
NEBB BET PUBLICATION
Published Date: 08/01/2019
PROCEDURAL STANDARD FOR BUILDING ENCLOSURE TESTING
$0.3
NEBB BET PUBLICATION
NEBB BET PUBLICATION
Published Date: 08/01/2019
PROCEDURAL STANDARD FOR BUILDING ENCLOSURE TESTING
$62.1
NEBB BET PUBLICATION
NEBB BET PUBLICATION
Published Date: 03/01/2015
PROCEDURAL STANDARD FOR BUILDING ENCLOSURE TESTING
$62.1
NEBB BET PUBLICATION
NEBB BET PUBLICATION
Published Date: 03/01/2015
PROCEDURAL STANDARD FOR BUILDING ENCLOSURE TESTING
$123.9
NEBB BUILDING SYSTEMS
NEBB BUILDING SYSTEMS
Published Date:
Procedural Standards for Whole Building Systems Commissioning of New Construction
NEBB BUILDING SYSTEMS
NEBB BUILDING SYSTEMS
Published Date: 01/01/2019
PROCEDURAL STANDARDS FOR WHOLE BUILDING SYSTEMS COMMISSIONING OF NEW CONSTRUCTION
$62.1