Cart (0)
  • No items in cart.
Total
$0
There is a technical issue about last added item. You can click "Report to us" button to let us know and we resolve the issue and return back to you or you can continue without last item via click to continue button.
Home
Content
eLibrary
Filters:
FORMAT
EDITION
to
PUBLISHER
AABC
(1)
AAMI
(337)
ACI
(589)
AISC
(54)
ASA
(234)
ASCE
(996)
ASHRAE
(657)
ASME
(2161)
ASSE
(117)
ASTM
(94394)
AWC
(54)
AWWA
(568)
BHMA
(124)
BICSI
(33)
BIFMA
(21)
BOMA
(20)
BSI
(94534)
CHD
(3)
CRSI
(17)
IAHSS
(1)
IAPMO
(374)
ICC
(315)
IEEE
(6731)
IES
(241)
ISEA
(16)
Joint Commission
(184)
Joint Commission Int.
(1)
NETA
(6)
NFPA
(1646)
TCNA
(17)
TMS
(19)
USGBC
(28)
WILEY
(4)
 
AR
(6)
AZ
(7)
CA
(115)
CT
(3)
FL
(57)
ID
(5)
IL
(5)
IN
(1)
KY
(1)
LA
(2)
MI
(25)
MN
(27)
NC
(27)
NJ
(13)
NY
(61)
OH
(24)
OR
(22)
PA
(7)
RI
(8)
SC
(20)
SD
(1)
TX
(3)
VA
(50)
VT
(6)
WA
(31)
CONTENT TYPE
 Act
 Admin Code
 Announcements
 Bill
 Book
 CADD File
 CAN
 CEU
 Charter
 Checklist
 City Code
 Code
 Commentary
 Comprehensive Plan
 Conference Paper
 County Code
 Course
 DHS Documents
 Document
 Errata
 Executive Regulation
 Federal Guideline
 Firm Content
 Guideline
 Handbook
 Interpretation
 Journal
 Land Use and Development
 Law
 Legislative Rule
 Local Amendment
 Local Code
 Local Document
 Local Regulation
 Local Standards
 Manual
 Model Code
 Model Standard
 Notice
 Ordinance
 Other
 Paperback
 PASS
 Periodicals
 PIN
 Plan
 Policy
 Product
 Product - Data Sheet
 Program
 Provisions
 Requirements
 Revisions
 Rules & Regulations
 Standards
 State Amendment
 State Code
 State Manual
 State Plan
 State Standards
 Statute
 Study Guide
 Supplement
 Sustainability
 Technical Bulletin
 All
  • ASTM
    E2475-10 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
    Edition: 2010
    $103.58
    Unlimited Users per year

Description of ASTM-E2475 2010

ASTM E2475 - 10

Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

Active Standard ASTM E2475 | Developed by Subcommittee: E55.01

Book of Standards Volume: 14.02




ASTM E2475

1. Scope

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:


2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

E456 Terminology Relating to Quality and Statistics

E2281 Practice for Process and Measurement Capability Indices

E2474 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

E2617 Practice for Validation of Empirically Derived Multivariate Calibrations

U.S. Government Publications

U.S.FDAPAT Guidance Document, Guidance for Industry PATA Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance

Keywords

control; pharmaceutical manufacture; process understanding;


ICS Code

ICS Number Code 11.120.01 (Pharmaceutics in general)


DOI: 10.1520/E2475-10

ASTM International is a member of CrossRef.

ASTM E2475

The following editions for this book are also available...

This book also exists in the following packages...

Year Publisher Title Annual Price
VAR
ASTM
 [+] $2,029.11 Buy
VAR
ASTM
 [+] $3,716.67 Buy

Subscription Information

MADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.

 

Some features of MADCAD.com ASTM Standards Subscriptions are:

- Online access: With MADCAD.com’ s web based subscription service no downloads or installations are required. Access ASTM Standards from any browser on your computer, tablet or smart phone.

- Immediate Access: As soon as the transaction is completed, your ASTM Standards Subscription will be ready for access.

 

For any further information on MADCAD.com ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.

 

About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
GROUPS