iSpeak Blog
iSpeak Blog
The second day of the 2023 ISPE Facilities of the Future Conference in North Bethesda, Maryland, included keynotes addressing various facets of the industry and their impact on future facilities planning and development. Key among these included a presentation by the director of FDA’s CBER on cell and gene therapy manufacturing and a range of considerations behind new facility planning from a...
iSpeak Blog
The updated EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products released in August 2022 introduced changes which require more stringent sterile manufacturing processes, including implementing a contamination control strategy and new technology to reduce the risk of contamination. Regulators discussed those changes and how they impact manufacturing practices during panel...
iSpeak Blog
ISPE is launching a new program, Enabling Global Pharma Innovation: Delivering for Patients in support of many regulatory agencies’ ambitions to promote introduction of innovative pharmaceutical manufacturing. It is incumbent for industry to modernize and innovate pharmaceutical manufacturing to improve efficiency and increase confidence in quality assurance for the benefit of...
iSpeak Blog
What is Commenting?
As regulatory agencies invite public comment on a new or revised regulation or guidance, they look to ISPE for input on the latest scientific and technical developments. ISPE submits official comments when we are able to provide that input.
ISPE’s commenting process is overseen by ISPE’s Regulatory Quality Harmonization Committee (RQHC)...
iSpeak Blog
With the widespread use of paperless validation software application comes the need to present digital CQV content to inspection professionals. This blogpost will summarize inspection topics for presenting digital CQV content and provide a list of common questions encountered during inspection events.