PDATR29(2012)清洁验证中英对照版

PDA TR29 (2012) 清洁验证 中英对照版

Technical Report No. 29 (Revised 2012)Points to Consider for Cleaning Validation

PDA TR29 (2012) 清洁验证 中英对照版

PDA Task Force on Technical Report No. 29 (Revised 2012): Points to Consider for Cleaning Validation

Authors

Destin A. LeBlanc, Cleaning Validation Technologies (Chair)

Gretchen Allison, PfizerJennifer L. Carlson, GenentechKoshy George, ConsultantIgor Gorsky, ConcordiaValSourceIrwin S. Hirsh, Novo Nordisk AS

Jamie Osborne, Siegfried (USA), Inc.Greg Randall, Baxter BiosciencePierre-Michel Riss, Eli Lilly

George Verghese, STERIS CorporationJenn Walsh, Bristol-Myers SquibbVivienne Yankah, Sanofi-Pasteur, Ltd.

The content and views expressed in this Technical Report are the result of a consensus achieved by the authorizing Task Force and are not necessarily views of the organizations they represent.

PDA TR29 (2012) 清洁验证 中英对照版

Points to Consider for Cleaning Validation

Technical Report No. 29 (Revised 2012)

ISBN: 978-0-939459-48-3

© 2012 Parenteral Drug Association, Inc. All rights reserved.

PDA TR29 (2012) 清洁验证 中英对照版

Paradigm Change in Manufacturing Operations (PCMOSM)

PDA launched the project activities related to the PCMO program in December 2008 to help imple-ment the scientific application of the ICH Q8, Q9 and Q10 series. The PDA Board of Directors ap-proved this program in cooperation with the Regulatory Affairs and Quality Advisory Board, and the Biotechnology Advisory Board and Science Advisory Board of PDA.

Although there are a number of acceptable pathways to address this concept, the PCMO program fol-lows and covers the drug product lifecycle, employing the strategic theme of process robustness with-in the framework of the manufacturing operations. This project focuses on Pharmaceutical Quality Systems as an enabler of Quality Risk Management and Knowledge Management.

Using the Parenteral Drug Association’s (PDA) membership expertise, the goal of the Paradigm Change in Manufacturing Operations Project is to drive the establishment of ‘best practice’ docu-ments and /or training events in order to assist pharmaceutical manufacturers of Investigational Medicinal Products (IMPs) and commercial products in implementing the ICH guidelines on Phar-maceutical Development (ICH Q8, Q11), Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10).

The PCMO program facilitates communication among the experts from industry, university and regula-tors as well as experts from the respective ICH Expert Working Groups and Implementation Working Group. PCMO task force members also contribute to PDA conferences and workshops on the subject.PCMO follows the product lifecycle concept and has the following strategic intent:

Enable an innovative environment for continual improvement of products and systems Integrate science and technology into manufacturing practice

Enhance manufacturing process robustness, risk based decision making and knowledge manage-ment

Foster communication among industry and regulatory authorities

The Product Life Cycle

Pharmaceutical Development

Technology Transfer

Commercial Manufacturing

Product Discontinuation

PDA TR29 (2012) 清洁验证 中英对照版

1.0 Introduction .........................................................1

1.1 Purpose/Scope ................................................12.0 Glossary of Terms ...............................................3

2.1 Definition of Acronyms ....................................53.0 Cleaning Process Design and Development .......7

3.1 Cleaning Process Design .................................73.2 Cleaning Process Overview .............................8

3.2.1 Physical-chemical Aspects .................93.3 Design Considerations ...................................10

3.3.1 Location of Cleaning ..........................103.3.1.1 In-Place Cleaning ..........................103.3.1.1.1 Clean-in-Place (CIP) Systems .......103.3.1.1.2 Solvent Reflux Cleaning ................113.3.1.1.3 Placebo Batches as a

Cleaning Method ..........................11

3.3.1.2 Out-of-Place Cleaning ...................113.3.1.2.1 Clean-Out-of-Place Systems .........123.3.2 Automated vs. Manual Systems .......123.3.2.1 Manual Processes ........................123.3.2.2 Semi-Automated Processes .........123.3.2.3 Automated Processes ..................133.3.3 Soil Evaluation and Categorization .....133.3.3.1 Soil Categories .............................133.3.3.2 Soil Removal.................................133.3.4 Equipment Considerations .................143.3.4.1 Dedicated – Nondedicated

Manufacturing Equipment ............14

3.3.4.2 Nonproduct Contact – Product

Contact Surfaces ..........................15

3.3.4.3 Low-Risk Sites – High-Risk Sites .153.3.4.4 Materials of Construction .............153.3.5 Operational Considerations ................153.3.6 Cleaning Agent Selection ..................163.3.7 Product Considerations......................163.3.7.1 Product Risk Considerations .........173.4 Cleaning Development

Laboratory Experiments ................................173.4.1 Soil Selection ....................................173.4.2 Parameter Selection ..........................183.4.2.1 Parameter Interactions ................193.4.3 Measurements to Determine

Cleaning Effectiveness ......................193.5 Cleaning Process Scale-Up ............................19

3.5.1 Setting Process Controls ...................193.6 Applying the “Design Space” Concept to

Cleaning Processes ......................................203.7 Standard Operating Procedures .....................213.8 Operator Training for …… 此处隐藏：33135字，全部文档内容请下载后查看。喜欢就下载吧 ……