In our previous blog post, we concluded that although legacy pharmaceutical manufacturing facilities present many challenges, they are worth rehabilitating. In this discussion, we explain the components of a master plan. In our next blog post, we talk...

Following ISPE’s 2013 Drug Shortages Survey and the Society’s commitment to seek best-practice solutions to the problems identified, ISPE today announces a line-up of activities that will bring pharmaceutical industry stakeholders together at its first...

ISPE’s North and South American Affiliate Council (NASAAC) met with Board Members and Staff in Tampa, Florida, on 24-25 March 2014, to collaborate on strategies to strengthen ISPE and help enhance the success of ISPE’s Affiliates and Chapters in the...

Now more than ever, pharmaceutical professionals are being asked to do more in shorter time periods within tighter financial confinements. In addition, regulations for the industry continue to increase and change rapidly. To meet this every demanding...

With increasing complexity of supply chains and the need to rapidly respond to internal and external demands, we must remain committed to using sound science and risk based approaches to ensure control. The 3rd Annual ISPE-FDA CGMP Conference is the...

The 2014 Facility of the Year Awards program is shaping up to be one of the most noteworthy events of the year. A few weeks ago, we talked about what the pharmaceutical and biopharmaceutical industry can learn from the facilities recognized by FOYA....

Pharma EXPO is an exciting new event making its debut this November in Chicago. Brought to you by ISPE and PMMI, Pharma EXPO will bring together thousands of pharmaceutical, biopharmaceutical, medical device, personal care and nutraceutical manufacturers...

Around the world, countless patients with a high degree of unmet medical needs are in urgent need of new therapeutic alternatives. For many of these patients, access to new innovative medicines via the well-defined clinical trial process or through...

As a planning team member of the Statistician Forum, I am extremely excited to see that the conference discussion topics are attracting so many statisticians from around the world. Since the issuance of the FDA Guidance on Process Validation in January...

The pharmaceutical industry is facing a restructuring in quality management.  The manufacturing goal of producing consistent, high-quality products with minimal regulatory oversight is revealing a new path. The FDA and CDER are in the process of...

The submissions are in. The judges are preparing to meet.  That can only mean one thing: the 2014 Facility of the Year Awards (FOYA) Category Winners will soon be announced, kicking off our year-long celebration of industry’s dedication to excellence in...

The first edition of the ISPE Biopharmaceutical Manufacturing Facilities Baseline Guide was issued in June 2004. Its concepts have been phased-in over the past several years. Since 2004, the Industry, processing technology and views to manufacturing have...

How do you build the quality that is essential to all processes and products? Training auditors to conduct good audits is one way. These are some critical skills auditors must know to conduct successful audits: Using audit trails and checklists to...

This post is another a series of reports on the many regulatory-related activities your fellow ISPE Members are undertaking, and how you can add your voice to these impactful initiatives.

Rouge development due to the usage of high temperature water in piping and vessels is a continuing issue in the pharmaceutical industry.  Many SOPs and directives are developed and instituted at individual biopharmaceutical and traditional pharmaceutical...

François Sallans, PharmD VP Quality & Compliance, Chief Quality Officer Johnson & Johnson Our Member Spotlight is Francois Sallans, Vice...

Complete separation of process and products from each other within a biopharmaceutical manufacturing facility is an operational and regulatory imperative. But does that necessarily mean physical separation? Or can separation be achieved in common...

This post is the first in series of reports on the many regulatory-related activities your fellow ISPE Members are undertaking, and how you can add your voice to these impactful initiatives. The Advancing Breakthrough Therapies for Patients Act was...