ISPE US Standards Standards

APQ Guide: Corrective Action & Preventive Action (CAPA) System

11/1/2020 - PDF sécurisé - English - ISPE
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€592.00

ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

8/1/2020 - PDF sécurisé - English - ISPE
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€914.00

ISPE Good Practice Guide: Critical Utilities GMP Compliance

6/1/2020 - PDF sécurisé - English - ISPE
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€684.00

GAMP Good Practice Guide: Data Integrity by Design

1/1/2020 - PDF sécurisé - English - ISPE
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€431.00

ISPE Good Practice Guide: HVAC and Process Equipment Air Filters

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
12/1/2019 - PDF sécurisé - English - ISPE
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€569.00

ISPE Good Practice Guide: Asset Management

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
11/1/2019 - PDF sécurisé - English - ISPE
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€442.00

ISPE Baseline Guide: Volume 4 - Water and Steam Systems, Third Edition

9/1/2019 - PDF sécurisé - English - ISPE
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€799.00

ISPE Baseline Guide: Volume 5 - Commissioning and Qualification, 2nd Edition

6/1/2019 - PDF sécurisé - English - ISPE
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€914.00

GAMP Good Practice Guide: Data Integrity - Manufacturing Records

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
5/1/2019 - PDF sécurisé - English - ISPE
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€431.00

ISPE Good Practice Guide: Process Validation

1/1/2019 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Single-Use Technology

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
11/1/2018 - PDF sécurisé - English - ISPE
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€529.00

ISPE GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
10/1/2018 - PDF sécurisé - English - ISPE
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€403.00

ISPE Baseline Guide: Volume 3 - Sterile Product Manufacturing Facilities, Third

4/1/2018 - PDF sécurisé - English - ISPE
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€592.00

ISPE Good Practice Guide: Technology Transfer

1/1/2018 - PDF sécurisé - English - ISPE
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€529.00

ISPE GAMP Good Practice Guide: Computerized GCP Systems & Data

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
12/1/2017 - PDF sécurisé - English - ISPE
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€529.00

ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
8/1/2017 - PDF sécurisé - English - ISPE
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€529.00

ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Product

7/1/2017 - PDF sécurisé - English - ISPE
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€592.00

ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facili

6/1/2017 - PDF sécurisé - English - ISPE
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€529.00

ISPE GAMP Guide: Records and Data Integrity

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
3/1/2017 - PDF sécurisé - English - ISPE
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€454.00

ISPE GAMP Good Practice Guide: Global Information Systems Control and Compliance

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
2/1/2017 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process

12/1/2016 - PDF sécurisé - English - ISPE
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€529.00

ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms

11/1/2016 - PDF sécurisé - English - ISPE
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€592.00

ISPE Good Practice Guide: Management Engineering Standards

8/1/2016 - PDF sécurisé - English - ISPE
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€167.00

ISPE Good Practice Guide: Operations Management

1/1/2016 - PDF sécurisé - English - ISPE
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€529.00

ISPE Sustainability Handbook:2015

12/1/2015 - PDF sécurisé - English - ISPE
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€242.00

ISPE GAMP Good Practice Guide: A Risk-Based Approach to Regulated Mobile Applica

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
10/1/2014 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Clinical Supply Systems

3/1/2014 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharm

1/1/2014 - PDF sécurisé - English - ISPE
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€529.00

ISPE Guide: Biopharmaceutical Process Development and Manufacturing

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
10/31/2013 - PDF sécurisé - English - ISPE
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€592.00

ISPE Good Practice Guide: Booklet Labels

3/1/2013 - PDF sécurisé - English - ISPE
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€472.00

ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigatio

1/1/2013 - PDF sécurisé - English - ISPE
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€472.00

ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities

1/1/2013 - PDF sécurisé - English - ISPE
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€592.00

GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Secon

12/1/2012 - PDF sécurisé - German - ISPE
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€529.00

GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Secon

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
12/1/2012 - PDF sécurisé - English - ISPE
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€529.00

GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Comp

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
10/1/2012 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Quality Laboratory Facilities

9/1/2012 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems

7/1/2012 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Assessing the Particulate Containment Performance of P

The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)
5/1/2012 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities

5/1/2012 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Comparator Management

3/1/2012 - PDF sécurisé - English - ISPE
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€529.00

ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept

1/1/2012 - PDF sécurisé - English - ISPE
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€472.00

ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept

1/1/2012 - PDF sécurisé - English - ISPE
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€472.00

ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept

11/1/2011 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry

11/1/2011 - PDF sécurisé - English - ISPE
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€529.00

ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept

11/1/2011 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Interactive Response Technology

11/1/2011 - PDF sécurisé - English - ISPE
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€322.00

ISPE Good Practice Guide: Process Gases

7/1/2011 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Cold Chain Management

5/1/2011 - PDF sécurisé - English - ISPE
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€529.00

GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
2/1/2011 - PDF sécurisé - English - ISPE
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€529.00

GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Secon

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
11/1/2010 - PDF sécurisé - English - ISPE
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€529.00

GAMP Good Practice Guide: Manufacturing Execution Systems - A Strategic and Prog

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
2/1/2010 - PDF sécurisé - English - ISPE
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€529.00

ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Compute

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
1/1/2010 - PDF sécurisé - English - ISPE
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€529.00

ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)

9/1/2009 - PDF sécurisé - English - ISPE
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€529.00

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (German Vers

2/1/2008 - PDF sécurisé - German - ISPE
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€656.00

ISPE Good Practice Guide: Development of Investigational Therapeutic Biological

8/1/2007 - PDF sécurisé - English - ISPE
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€529.00

ISPE Baseline Guide: Volume 1 - Active Pharmaceutical Ingredients (Second Editio

6/1/2007 - PDF sécurisé - English - ISPE
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€592.00

GAMP Good Practice Guide: Electronic Data Archiving

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
1/1/2007 - PDF sécurisé - English - ISPE
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€529.00

Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Mate

1/1/2006 - PDF sécurisé - English - ISPE
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€529.00

GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records

Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
2/1/2005 - PDF sécurisé - English - ISPE
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€529.00

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