Read, Learn, Innovate: Top Blog Posts from April 2021
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from April 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Brexit Transition Period Is Over – What Can We Say So Far?
The UK Entered a New Relationship with the European Union on 1 Jan 2021. The United Kingdom (UK) (England, Northern Ireland, Scotland and Whales) is no longer part of the European Union (EU) Customs Union. Simply put, it means movement of goods between the UK and the EU are now to be an import and export trade transaction.
Women in Pharma®: Forged in the Crucible
Prathiba Sampath, PMPFor me, both personally and professionally, 2020 started off as an incredible year. My husband and I were expecting the arrival of our first child in April. At work, I was being entrusted with increasing responsibilities and being groomed for a promotion, while having an incredible learning journey. I’d taken the lead on the development project for a new manufacturing facility, and it was looking like I was headed for a high-impact moment in my career.
The Future of Contract Manufacturing for the Pharmaceutical Industry
Many factory productions can be outsourced to contract manufacturers (CMs) in order for businesses to continue providing quality products to their customers in a cost-effective way, and so they can focus on other aspects of their business, increasing their overall productivity and efficiency, and improving their bottom line.
How Should We Handle Requirements in a GxP Compliant Agile Software Development Process?
Successful delivery requires ensuring we build the right system that is fit for the intended use, not just ensuring we build the system right. Traditionally, documented Requirements are termed as the “User Requirements Specification” (URS) within pharmaceutical projects and are often interpreted as a key “must have” document containing the full set of requirements before any other work is done, regardless of what project approach is used. This is the Certainty Mindset in action, that was discussed in our earlier blog However, Annex 11 and GAMP® 5 Appendix D1 do state that Requirements may not initially be fully defined, e.g., for some Category 5 systems, requirements will be developed during subsequent phases of the project, which nicely fits the Discovery Mindset discussed in the same blog.
Q&A: User Requirements Specifications Related to Commissioning & Qualification
This blog is the first of four posts addressing questions received during the August 2019 webinar summarizing the introduction of 2nd Edition, ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide provides a well-defined framework for a lifecycle Quality Risk Management (QRM) commissioning and qualification (C&Q) approach to verification and documentation of fitness for use.
