Low prices! Originals & Official Editions! Save your budget and time!
standardsupdate.com: Standards Update Online Store
Contacts
  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 Czech version):
200 business days
SKU:
pda-tr-54-2_2030626
Choose Document Language:
97.50 €
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
97.50 €
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
97.50 €
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
97.50 €
PDA TR 83
PDA TR 83
Published Date: 2019
Technical Report No. 83 (TR 83) Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response
97.50 €

Best-Selling Products

AIHA AEAB06-715
AIHA AEAB06-715
Published Date: 01/01/2006
Essential Air Monitoring Methods (MAK-Collection for Occupational Health and Safety)
62.40 €
AIHA AEAG00-382
AIHA AEAG00-382
Published Date: 01/01/2000
Investigations: A Handbook for Prevention Professionals
31.80 €
AIHA AEAG07-726
AIHA AEAG07-726
Published Date: 01/01/2007
Guidance for Conducting Control Banding Analyses
36.00 €
AIHA AEAG99-381
AIHA AEAG99-381
Published Date: 01/01/2000
User's Guide to A Strategy for Assessing and Managing Occupational Exposures
AIHA AEAH07-725
AIHA AEAH07-725
Published Date: 01/01/2007
Preventing Hazards at the Source
36.30 €
AIHA AEAH10-559
AIHA AEAH10-559
Published Date:
2010 ERPG & WEEL Handbook
17.40 €