Category
Recently Viewed Products
-
CIE 054.2
$114.48$68.69 -
JEDEC JESD90
$60.00$36.00 -
JEDEC JESD99C
$163.00$97.80 -
NETA ATS
$290.00$174.00 -
ISPE Good Practice Guide: Cold Chain Management
$460.00$276.00
GAMP Good Practice Guide: Data Integrity – Manufacturing Records
$375.00 $225.00
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2019
Manufacturing systems, with their link to the physical process, have an obvious impact on patient safety and product quality. Careful consideration of data integrity risks, alongside all other risk types, provides a more complete assessment of the GMP risks associated with the system. In addition, there has been an increase in recent years of data integrity citations relating to manufacturing data. This Guide addresses the expectations for data integrity in a GMP environment to aid companies in meeting regulatory requirements.
The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them. Additionally, system-specific examples of topics such as segregation of duties and critical validation activities to support data integrity are discussed. Included are “quick wins” – suggestions that can create considerable improvement in the integrity of manufacturing system data with only modest resources.
This Guide is positioned under the ISPE GAMP® Guide: Records and Data Integrity and is aligned with ISPE GAMP®5: A Risk-Based Approach to Compliant GxP Computerized Systems.
Product Details
- Published:
- 05/01/2019
- ISBN(s):
- 9781946964205
- Number of Pages:
- 156
- File Size:
- 1 file , 6.4 MB
- Note:
- This product is unavailable in Russia, Belarus
Related products
-
ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)
$410.00$246.00Add to cartHandbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2013
-
ISPE Baseline Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities
$515.00$309.00Add to cartHandbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2013
-
ISPE Good Practice Guide: Booklet Labels
$410.00$246.00Add to cartHandbook / Manual / Guide by International Society for Pharmaceutical Engineering, 03/01/2013
-
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 4 – Process Performance and Product Quality Monitoring System
$410.00$246.00Add to cartHandbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2012