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GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems

GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This...
INFORMATION SYSTEMS
GOOD AUTOMATED MANUFACTURING PRACTICE (GAMP®)
...
INFORMATION SYSTEMS
GOOD AUTOMATED MANUFACTURING PRACTICE (GAMP®)
...
INFORMATION SYSTEMS
GOOD AUTOMATED MANUFACTURING PRACTICE (GAMP®)

Baseline Guide Volume 1: Active Pharmaceutical Ingredients, Second Edition

This revised Guide builds on the original principles of ISPE's Baseline® Guide Volume 1, Active Pharmaceutical Ingredients, (originally entitled Bulk Pharmaceutical ...

PRODUCT DEVELOPMENT & PRODUCTION SYSTEMS
ACTIVE PHARMACEUTICAL INGREDIENTS

The Guide is designed to provide a valuable tool for the development of in-house training sessions for advanced training, building on the topics covered in the earlier Introductory US Clinical Trial Materials Training Guide. It may be used in a c...

END TO END SUPPLY CHAIN MANAGEMENT
INVESTIGATIONAL PRODUCTS
The GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) provides guidance in setting up a calibration management system, which will give a structured approach to instrument risk assessment, calibration program m...
INFORMATION SYSTEMS
GOOD AUTOMATED MANUFACTURING PRACTICE (GAMP®)
Recently updated to conform with GAMP® 5 concepts and terminology, as well as recent regulatory and industry developments, the ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition) con...
INFORMATION SYSTEMS
GOOD AUTOMATED MANUFACTURING PRACTICE (GAMP®)
The Guide uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturing related functions that integrates business and process controls, information flow, and human interac...
INFORMATION SYSTEMS
GOOD AUTOMATED MANUFACTURING PRACTICE (GAMP®)
During the operational life of a GxP system regulators usually focus on the integrity, consistency, and completeness of controls required to maintain compliance. This Guide highlights the importance of the operation phase of the system lifecycle, whe...
This GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision of the GAMP® Good Practice Guide: Validation of Process Control Systems. It provides guidance and examples on the application of the principles and fra...
INFORMATION SYSTEMS
GOOD AUTOMATED MANUFACTURING PRACTICE (GAMP®)
This Guide helps the reader to maximize testing efficiency without compromising the quality of GxP Systems by focusing testing on areas that have the greatest impact and eliminating duplicate testing. This GAMP Good Practice Guide has been recently e...
INFORMATION SYSTEMS
GOOD AUTOMATED MANUFACTURING PRACTICE (GAMP®)
This Guide helps the reader to maximize testing efficiency without compromising the quality of GxP Systems by focusing testing on areas that have the greatest impact and eliminating duplicate testing. This GAMP Good Practice Guide has been recently e...
INFORMATION SYSTEMS
GOOD AUTOMATED MANUFACTURING PRACTICE (GAMP®)
The Biopharmaceutical Manufacturing Facilities Baseline® Guide explores products and facilities that house biotechnological processes. More specifically, it applies to process design ties to facility design, controlled processing, preventing contamin...
PRODUCT DEVELOPMENT & PRODUCTION SYSTEMS
BIOTECHNOLOGY
The ISPE Guide: Biopharmaceutical Process Development and Manufacturing focuses on the development and the process approaches and practices involved in providing cost effective, regulated manufacturing of biopharmaceutical products in a timely manner...
PRODUCT DEVELOPMENT & PRODUCTION SYSTEMS
BIOTECHNOLOGY

The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition) has been updated to address a broader selection of containment technologies and processing equipment. It will provide tech...

FACILITIES AND EQUIPMENT
CONTAINMENT
Investigational Therapeutic Biological Products - This Guide will consider the major issues that will confront a biopharmaceutical company in moving therapeutic biological products from the laboratory to the clinic and beyond. The Guide is inten...
END TO END SUPPLY CHAIN MANAGEMENT
INVESTIGATIONAL PRODUCTS

This Guide was written to create methods for standardizing the format, design and content of clinical trial booklet labels. Because booklet labels contain vital information for testing sites and subjects, the Guide enables more consistent use of b...

END TO END SUPPLY CHAIN MANAGEMENT
INVESTIGATIONAL PRODUCTS

Increasing volumes of cold products, the complexity of these products, and the complexity of the associated supply chain are causes for concern. Organizations need adequate control over cold chain of pharmaceutical and biopharmaceutical distributi...

END TO END SUPPLY CHAIN MANAGEMENT
PACKAGING
The ISPE Good Practice Guide: Comparator Management is the pharmaceutical industry's first-ever resource for comparator processes. It has been developed to use as a central reference source that establishes strategic and tactical considerations relat...
END TO END SUPPLY CHAIN MANAGEMENT
INVESTIGATIONAL PRODUCTS
This first edition of the ISPE Good Practice Guide: Good Engineering Practice covers the complete lifecycle of engineering from concept to retirement. The Guide:
  • Aims to promote a common understanding of the concept and principles of GEP de...
FACILITIES AND EQUIPMENT
PROJECT MANAGEMENT