LabPromEngineering takes part in review of ISPE guidances

ISPE Baseline Commissioning and Qualification 2nd edition.

The purpose of this Guide is to provide a detailed description of a science and risk-based approach for the Commissioning and Qualification of Facilities and Equipment, providing an update to the Baseline® Guide on C&Q that is adequate to allow the development and implementation of an efficient effective program.

The Guide will address a number of the areas that traditionally cause concern if engineering documents are to be used to support Qualification – e.g. Good Documentation Practice, Definition of test record document format and signature requirements, and effective use of vendor assessments.

The goal of the Team is to produce a document that describes a lean effective program that may be used to provide confirmation that facilities and equipment are fit for purpose.

HVAC and Process Equipment Air Filters Good Practice Guide.

This Good Practice Guide is intended to be a reference on the selection, specification, testing and operation of filters in pharmaceutical applications. It explains the principles and objectives of filter testing during manufacturing and on site.