It’s time for another edition of the Reading Roundup featuring the top blog posts from November 2016. Start off your weekend by kicking back and catching up on what the pharmaceutical industry was reading in November.

Technology Transfer of Manufacturing Processes: Best Practices

ISPE Biotechnology Steering Committee Presents: Technology Transfer of Manufacturing Processes: Best Practices. This blog post will describe several best practices regarding technology transfer of manufacturing processes between several sending and receiving sites across a global network. Read More >>

Good Manufacturing Practices: Temperature Mapping of Controlled Temperature Chambers

There is an increased regulatory interest in cold chain driven by the growing number of products requiring controlled temperature shipping and storage, the complexity of the distribution network for the products, and governmental requirements for distribution of vaccines. Read More >>

Data Quality and Data Integrity: What is the Difference?

Wikipedia defines data integrity as “maintaining and assuring the accuracy and consistency of data over its entire life-cycle”(Ref 1).  The FDA introduced the acronym “ALCOA” (Ref 2) to provide attributes of integrity; the term “ALCOA+”(Ref 3) adds four additional attributes. Read More >>

Life Cycle Assessment Analysis of Pharma Production Facility Part 3

The analysis of the operational phase becomes essential to understand the environmental performance of the facility. In particular, it is necessary to examine the relationship between the three basic types of systems that define the operational phase as described previously (see Table B from Part 2). These are process, building, and utility systems. Read More >>

Life Cycle Management & Manufacturing of Biotech Therapies

Biotech therapies are comprising a greater portion of the pipelines and approvals of New Molecular Entities by global health authorities – adding to this are the approvals of biosimilars and programs to access these medicines in developing countries.  This unprecedented growth makes the 2016 Biopharmaceutical Manufacturing Conference a must-attend conference for anyone who is addressing the challenges and opportunities facing the biopharmaceutical manufacturing sector. Read More >>