ASTM E2474-2006 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology《利用过程分析技术进行制药过程设计的标准规程》.pdf

1、Designation: E 2474 06Standard Practice forPharmaceutical Process Design Utilizing Process AnalyticalTechnology1This standard is issued under the fixed designation E 2474; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of

2、 last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.INTRODUCTIONProcess design is the systematic conversion of information about needs for a product intoknowledge about how to manu

3、facture this product. Products and manufacturing processes should bedesigned using science- and risk-based design strategies to manage variation.To attain this goal, integration of Process Analytical Technology (PAT) principles and tools duringprocess design will enhance opportunities to build, main

4、tain, and expand science- and risk-basedprocess understanding throughout a product lifecycle. The product lifecycle includes the period inproduction as well as development.Process understanding will be the foundation to establish manufacturing (process selection,methodology, implementation, and prac

5、tice), process control (real-time control on the basis ofmeasured critical quality attributes), effective risk mitigation, and product release concepts.Process understanding will also enable regulatory strategies in that the level of regulatory scrutinymay reflect the demonstrated level of science-

6、and risk-based process understanding.1. Scope1.1 This practice covers process design, which is integral toprocess development as well as post-development processoptimization. It is focused on practical implementation andexperimental development of process understanding.1.2 The term process design as

7、 used in this practice canmean:1.2.1 The activities to design a process (the process design),and/or1.2.2 The outcome of this activity (the designed process).1.3 The principles in this practice are applicable to bothdrug substance and drug product processes. For drug products,formulation development

8、and process development are inter-related and therefore the process design will incorporateknowledge from the formulation development.1.4 The principles in this practice apply during developmentof a new process or the improvement or redesign of an existingone, or both.1.5 This standard does not purp

9、ort to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 Referenced Standard

10、s:FDA Guidance for Industry: PATA Framework for Inno-vative Pharmaceutical Development, Manufacturing, andQuality Assurance, September 20042ICH Guidance: ICH Q8 Pharmaceutical Development, Step4 Document, November 20053ICH Guidance: ICH Q9 Quality Risk Management, Step 4Document, November 200533. PA

11、T Process Design Practices3.1 Desired StateIn the desired state of a process, allsources of variation are defined and controlled, and endproduct variation is minimal. That implies that critical productattributes are controlled to target for all individual units of aproduct. As a result, processes ar

12、e capable of consistentlysupplying, unit to unit and batch to batch, the desired quality.Philosophy and Principles3.2 Practice #1: Risk Assessment and MitigationProductsand manufacturing processes should be designed to minimize1This practice is under the jurisdiction of ASTM Committee E55 on Pharma-

13、ceutical Application of Process Analytical Technology and is the direct responsi-bility of Subcommittee E55.02 on PAT System Implementation desired state; manufacturing; PAT; phar-maceutical process design; process analytical technology; pro-cess understanding; quality risk managementASTM Internatio

14、nal takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their

15、 own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be

16、 addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards

17、, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).E2474063