Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly reducing the risk of contamination in manufacturing equipment. The implementation of single-use technology into a process requires a well-defined plan that minimizes surprises during the later stages of implementation.

The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts provides detailed practical guidance to support data integrity within a regulated organization. In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and quality of the data on which a regulatory decision is based.

The ISPE Japan Affiliate Manual on Pest Control expands on the concepts and policies set forth in the previous ISPE Japan Affiliate Handbook on Pest Control (English Translation, version 4) and offers advice for new and aging GMP facilities. It proposes plans for incorporating pest control best practices into the project schedule for new construction, including advice on integrating pest control requirements during all phases of construction, training construction staff, and determining areas to inspect both during and at the end of construction.