Pharmaceutical and biotech portfolios continue to transition from high volume blockbusters to a diversified set of lower volume, targeted therapeutics. At the same time, many companies are pursuing localized manufacturing to adjust to supply chain challenges and to improve access to medicine. The industry must also address increased pricing pressure due to inflation and government policies....

GAMP^® 5 (Second Edition) was published on 29th July 2022 and was presented and discussed at the 2023 ISPE Annual Meeting and at several local...

Here’s How Our Members Intend on Making It a Reality…

Each International Women’s Day, the world comes together to celebrate the social, economic, cultural, and political achievements of women, calling for accelerated equality across borders. International Women’s Day has taken place for over a century, with the first taking place in 1911 and having the support of over a million...

Just off the heels of ISPE’s Facilities of the Future Conference, which took place this past February, ISPE’s Women in Pharma continues to leverage its momentum to amplify the group’s mission to create a more equitable pharmaceutical industry on a grand scale.

The 2023 Facilities of the Future Conference Women in Pharma panel welcomed a full room. Seen from left to right: Carolina Serrano (moderator), Kerren Bergman, Vivianne Arencibia and Jessica Ballinger

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...

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...

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...

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)...

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.

ISPE’s long-time Asia-Pacific Regulatory Advisor Bob Tribe retired from ISPE at the end of 2022, bringing to a close more than 18 years of service to the Society.

ATMPs, Cell and Genetic therapies - or whatever other jurisdictions use – have come a long way. I am unsure how many of us have forgotten the early failures and setbacks. There was a time, in the early years, when serious side effects, such as deaths, endangered the field. It prompted the regulators to halt research, introducing various constraints and safeguards. In Europe, it felt like every...

Opening keynote addresses at the 2023 ISPE Facilities of the Future Conference focused on innovation in planning for future pandemics and reinventing medicines for a healthier world. The two-day conference on 31 January–1 February featured a range of sessions on topics including biomanufacturing, cell and gene therapy, digital transformation and Pharma 4.0™, emerging technologies, and facility...

On December 9-10, 2022, the two-day Senlan Bay Forum – ISPE Biopharmaceutical Engineering Summit 2022 was successfully held in Shanghai Peony Garden! The summit focused on the segmental production of macromolecules; the difficulties in the industrialization of gene and cell therapy; the construction of compliant and efficient CGT facilities; the process performance qualification (PPQ) for...

The ISPE Commissioning and Qualification (C&Q) Community of Practice (CoP) Steering Committee has developed a C&Q benchmarking survey intended to provide a comprehensive view of the current state of the industry, including adoption rate of Quality Risk Management (QRM) Based Integrated C&Q, C&Q best practices and key performance indicators. Completing this industry benchmarking...

Most Life Sciences manufacturers face issues while tracking material, equipment, and finished products in one way or another. While RFID solutions have been in use for a long time, they still can fail to identify the object because of constraints of reading requirements of distance. Real Time Location Systems (RTLS) solution can work as a panacea to overcome those constraints. These solutions...

We are The Culture Club, a self-formed cross-CoP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. As we are not all from the same CoP, we first needed to establish a way to connect and collaborate with all...

It’s hard to imagine life without instantaneous weather and time; however, some readers of this blog may know when weather, some years ago, was a mystery, and accurate time required a call from a pay phone to verify the correctness of your new Timex© watch!