-
-
Available Formats
- Availability
- Priced From ( in EUR )
-
Available Formats
-
- Immediate download
- €63.85
- Add to Cart
-
- Printed Edition
- Ships in 1-2 business days
- €63.85
- Add to Cart
-
- Printed Edition + PDF
- Immediate download
- €82.57
- Add to Cart
Customers Who Bought This Also Bought
-
ASTM E1386-23
Priced From €55.05 -
ASTM E2123-20
Priced From €52.84 -
ASTM E1231-24
Priced From €69.36 -
ASTM E1470-92(2006)
Priced From €55.05
About This Item
Full Description
1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992; FDA/ICH Q8). The framework is applicable to both active pharmaceutical ingredient (API) and to drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continuous process improvement efforts.
1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:
Document History
-
ASTM E2475-23
Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control- Most Recent
-
ASTM E2475-10(2016)
Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control- Historical Version
-
ASTM E2475-10
viewing
Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control- Historical Version