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good engineering practice in risk-based commissioning ... - ispe
Commissioning is the engineering process for delivering systems that meet established design requirements and stakeholder expectations. Qualification is the quality process for demonstrating and documenting that critical systems are suitable for their intended purpose.
commissioning and qualification in pharma: an overviewCommissioning and qualification are interrelated processes that ensure facilities, utilities, equipment, and systems used throughout pharmaceutical manufacturing fit their intended purpose. This blog post provides a basic introduction to commissioning and qualification, with important terms explained.
baseline guide vol 5: commissioning & qualification 2nd edition - ispeThe ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose.
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practical approach to commissioning and qualificationThis article offers a practical approach to commissioning and a method of synergy with qualification. Practical applications are explored, as well as the use of Enhanced Commissioning Documentation to minimize the qualification effort.
an introduction to pharmaceutical facility commissioning qualificationWhen the pharmaceutical industry uses the terms “commissioning” and “qualification,” commissioning could be applied to any facility, while qualification is an aspect of commissioning that refers to a facility that will be operated under good manufacturing practice (GMP) regulations.
commissioning and validation - practical pharmaceutical engineering ...Summary. Commissioning is an important aspect of pharmaceutical projects since a commissioning program will, in most cases, allow for a more efficient installation, qualification (validation), and subsequent operation such as manufacturing and facility maintenance.
ispe baseline® guide: volume 5 – commissioning and qualification ...The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose.