Articles

Pharmaceutical manufacturing sites that export their products around the world are often subjected to many GMP inspections each year by different regulatory authorities, with a significant number of these being duplicate, same-scope inspections. This is...

Moderna, Inc. is the 2019 Facility of the Year Category Winner for Facility of the Future for their New cGMP Clinical Manufacturing Facility in Norwood, MA.

Asia Pacific Pharma Outlook The healthcare market in the Asia Pacific (APAC) region is continuing to grow at a steady rate with an estimated 500-billion-dollar industry by 2020. This is due to rising development in smart manufacturing and government...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from July 2019. See trending ideas for regulatory compliance, biopharmaceutical innovation, and more for what the pharmaceutical industry was reading last month. Integrated...

The 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference will be held 30 September to 1 October in Singapore. The conference is modelled on the regional ISPE conferences held in North America and Europe each year and follows a successful pilot...

A fundamental flaw in the way the industry develops manufacturing processes could be the reason.

We are three months out from the 2019 ISPE Annual Meeting & Expo and we have finalized the titles and session topics for the Quality Systems and Regulatory Track. As director of this education track, I can tell you that the program is looking...

How CMOs keep conditions controlled and reduce costs with temporary power, climate control, 100% oil-free air

Pfizer Inc. is the 2019 ISPE Facility of the Year Category Winner for Facility Integration for their Pfizer Global Technology Center in Hangzhou, China.

With a packed agenda of Federal and State Regulators, the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference is the conference to attend where global and local pharmaceutical companies will come together to collaborate, share experiences and...

Ayako Nakajima General Manager Nissan Chemical Corporation in Japan Ayako Nakajima, a General Manager with Nissan Chemical Corporation in Japan, joined ISPE in 2002. In 2011, she became the Director of the ISPE Japan Affiliate, and in 2016, was elected...

You are sitting with a group of people around a table in a conference room. On the wall, a monitor displays a spreadsheet showing the inputs and outputs of a complex manufacturing process in a vast matrix. The purpose of the meeting is to assign risk...

Followers of FDA warning letters and Form 483s will have noticed that over the last 12 – 18 months, there have been increasing mention of data integrity issues around manufacturing data, often as a result of outdated equipment and practices, such as: No...

What is coming next in biopharmaceutical manufacturing? That question was addressed in plenary sessions at the 2019 ISPE Biopharmaceutical Manufacturing Conference 18-20 June in Boston on the second and third days of the conference. View more about the...

As our industry continues to evolve with new and innovative technologies, new product launches, the approval of biosimilars and the continued pressures to drive cost down and quality up, the question remains how to design infrastructure, including both...

In 2018, after 35 years, I retired from the U.S. Food & Drug Administration having spent a career as an FDA Investigator, beginning in the Orlando District Office, with stops in the Los Angeles District Office, and finally retiring from the Dallas...

Janssen Cilag SpA is the 2019 ISPE Facility of the Year Category Winner for Equipment Innovation for their Dosepak Equipment project in Latina, Italy.

The 2nd edition of the ISPE Good Practice Guide: Maintenance is currently under revision and the team leaders, Constantino Rodriguez (formerly Outlook Therapeutics) and George Wittman (JLL Chicago), are looking for additional volunteers to assist with...

The concept of the digital twin sounds like science fiction: a complete digital representation of your process or system, along with all the flexibility to play with simulations, creating feedback, and targeting optimizations. However, the foundation for...

Featured in this edition of ISpeak iSpeak Reading Roundup are the top blog posts from June 2019. Explore critical- industry initiatives, membership Membership highlights, and more for what the pharmaceutical industry was reading last month. The...

Bay Area leaders started to break the glass ceiling at Berkeley City Club. On the Annual International Worker's Day, May 1st, the ISPE San Francisco | Bay Area Program Committee had the pleasure of hosting its' first Women in Pharma® (WIP) event. The...