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 specific chapters for the update. They are looking for subject matter experts to draft and/or edit content for the following topics as they relate to maintenance:
As part of the authoring team, you would work closely with the team leaders to create technical content for a chapter/section of the document. You may also be involved with the review of other portions of the document. Team members are expected to work collaboratively with other authors while producing content. You must agree to be accountable for your aspect of the work by ensuring that comments are adequately resolved during the multiple review processes (including industry review).
If you are interested in participating in this Guide, please email your contact details, a brief description of your experience, and the specific topic(s) you would like to work on. Upon acceptance to the authoring team, you will be required to sign the ISPE Contributing Author Agreement form.
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...