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 President and...
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...
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...
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...
