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 Russian version):
200 business days

SKU:

Choose Document Language:
$97.5
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
$97.5
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
$97.5
PDA TR 81
Published Date: 2019
Technical Report No. 81 (TR 81) Cell-Based Therapy Control Strategy
$97.5
PDA PTC PUPSIT 1
Published Date: 02/01/2020
Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration
$97.5

Best-Selling Products

MHI CMAA 70
Published Date: 01/01/2015
Specification for Top Running Bridge and Gantry Type Multiple Girder Electric Overhead Traveling Cranes
$37.8
MHI CMAA 70
Published Date: 01/01/2020
Specification for Top Running Bridge and Gantry Type Multiple Girder Electric Overhead Traveling Cranes
$45
MHI CMAA 74
Published Date: 01/01/2020
Specifications for Top Running and Under Running Single Girder Electric Traveling Cranes Utilizing Under Running Trolley Hoist
$45
MHI CMAA 74
Published Date: 01/01/2015
Specification for Top Running and Under Running Single Girder Electric Overhead Cranes Utilizing Under Running Trolley Hoist
$37.8
MHI CMAA 78
Published Date: 01/01/2014
Standards and Guidelines for Professional Services Performed On Overhead and Traveling Cranes and Associated Hoisting Equipment (Revised 2015)
$14.4
MHI CMAA 79
Published Date: 01/01/2012
Crane Operator's Manual
$5.4