PDA TR 54 PDF

PDA TR 54 PDF

Name:
PDA TR 54 PDF

Published Date:
03/01/2012

Status:
Active

Description:

Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations

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_2030630

Choose Document Language:
97.50 €
Need Help?
PCMOSM PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides detailed guidance for the application and implementation of quality risk management (QRM) principles throughout the product lifecycle. Intended to align with ICH Q9 and present information that can be helpful to the reader on how to implement QRM, the report emphasizes QRM application during commercial manufacturing and integrating QRM into the pharmaceutical quality system.
File Size : 1 file , 760 KB
ISBN(s) : 9780939459384
Number of Pages : 61
Product Code(s) : 01054
Published : 03/01/2012

History


Related products

PDA TR 47
Published Date: 02/01/2010
Technical Report No. 47 (TR 47) Preparation of Virus Spikes Used for Virus Clearance Studies
97.50 €
PDA TR 67
Published Date: 10/01/2014
Technical Report No. 67, (TR 67) Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics
97.50 €
PDA TR 81
Published Date: 2019
Technical Report No. 81 (TR 81) Cell-Based Therapy Control Strategy
97.50 €
PDA PTC PUPSIT 1
Published Date: 02/01/2020
Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration
97.50 €

Best-Selling Products

IEC/PAS 60027-6 Ed. 1.0 en:2004
Published Date: 09/20/2004
Letter symbols to be used in electrical technology - Control technology
12.60 €
IEC/PAS 60050-732 Ed. 1.0 b:2007
Published Date: 06/06/2007
International Electrotechnical Vocabulary - Part 732: Computer network technology
61.20 €
IEC/PAS 60092-510 Ed. 1.0 en:2009
Published Date: 04/29/2009
Electrical installations in ships - Part 510: Special features - High-voltage shore connection systems
89.70 €
IEC/PAS 60099-7 Ed. 1.0 en:2004
Published Date: 04/27/2004
Surge arresters - Part 7: Glossary of terms and definitions from IEC publications 60099-1, 60099-4, 60099-6, 61643-1, 61643-12, 61643-21, 61643-311, 61643-321, 61643-331 and 61643-341
95.10 €
IEC/PAS 60191-6-18 Ed. 1.0 en:2008
Published Date: 01/22/2008
Mechanical standardization of semiconductor devices - Part 6-18: General rules for the preparation of outline drawings of surface mounted semiconductor device packages - Design guide for ball grid array (BGA)
29.10 €
IEC/PAS 60191-6-19 Ed. 1.0 en:2008
Published Date: 01/22/2008
Mechanical standardization of semiconductor devices - Part 6-19: Measurement methods of package warpage at elevated temperature and the maximum permissible warpage
32.10 €