ISPE

Welcome to the new iSpeak, which is now the official blog of ISPE. ISPE Members will be familiar with the name iSpeak, but this blog is an all-new ISPE initiative. Through iSpeak, the pharmaceutical community has a new platform to communicate and...

As those of you who attended the successful workshop at the second annual CGMP Conference in June or read Chris Potter’s recent article for Pharmaceutical Engineering know, ISPE has been leading the charge to bring industry and regulators together to...

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...

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...

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...

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...