iSpeak Blog
ISPE delivers technical and operational solutions to support across the global pharmaceutical and biopharmaceutical industry in the manufacture of quality medicines for patients.
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from July 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
There is sometimes a perception that computer systems validation requires a V-Model approach using a waterfall methodology. This means all requirements must be agreed before design can progress and in turn all design must be signed off before the system can be built, and so on until system release into operation.
Although travel continues to be reduced or restricted across the world, there is an upside: The 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum has now pivoted into a fully virtual conference and virtual executive forum providing attendees located anywhere in the world with real-time engagement with Regulatory and Industry leaders.
Our story started in October 2018 when I met a colleague at a conference and we had no time even to share our news: we were always in a hurry, only able to discuss business. The pharmaceutical industry is unique in its stability: many people who come here stay for a long time, and eventually colleagues become close friends. This is what happened to me: close professional engagement enabled me to develop relationships with amazing people, especially women.
Ensuring delivery of effective medicines requires an agile business strategy effectively utilizing technology to:
Making clinical trials more patient centric is among the many challenges facing the pharmaceutical industry. One method of improving the patient experience is by delivering study medication directly to patient homes, also known as Direct-to-Patient or DtP. However, the implementation of Direct-to-Patient may seem insurmountable in a highly regulated industry where specific regulations or guidance is lacking or vague.
The pharmaceutical industry is under increasing pressure to develop new therapies at a faster pace, while lowering drug costs, enhancing quality, and maintaining safety and a robust supply chain. Validation 4.0 ensures that validation processes are not a bottleneck but a strategic enabler of innovation, quality, and compliance by embracing artificial intelligence (AI), Internet of Things...
As the pharmaceutical industry evolves, sustainability is becoming a key driver of operational efficiency and long-term success. From reducing carbon emissions to enhancing workforce safety, companies are aligning their practices with sustainability goals. The 2025 ISPE Annual Meeting & Expo is the ideal platform to exchange ideas and...