The ISPE Commissioning & Qualification (C&Q) Community of Practice (CoP) conducted a survey in 2023 on the adoption of integrated C&Q, specifically on the use of paperless digital systems for planning, executing, and reporting C&Q activities. The survey revealed that 74% of respondents planned to use Digital Validation Tools (DVTs) for C&Q by 2024.
The 2025 ISPE Biotechnology Conference, scheduled for 2–3 June in Boston, MA, US, and virtually, will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic...
Each issue of Pharmaceutical Engineering® covers a wide range of topics relevant to the pharmaceutical industry, including scientific, technological, and regulatory advancements throughout the entire...
In 2023, the ISPE Commissioning and Qualification (C&Q) Community of Practice (CoP) conducted a survey on the adoption of integrated C&Q, focusing on the use of paperless/digital systems for planning, executing, and reporting C&Q activities. According to the survey, 74% of respondents anticipated using digital validation tools (DVTs) for C&Q by 2024. “Over the last five years,...
Ferdinando E. Aspesi, PhD, is a Senior Partner at Bridge Associates International, LLC, New Jersey, USA, where he advises pharmaceutical companies on quality strategy, organizational design, and quality and compliance issues. In his more than 44 years of experience in the industry, Aspesi has worked in active pharmaceutical ingredient (API) and drug products quality assurance and quality...
Trish Melton, PhD, has over 30 years of experience in the pharmaceutical industry, working in both manufacturing and service organizations. She is the Founder and Managing Director of MIME Solutions Ltd., a consultancy that has been providing support to the global pharmaceutical industry for 21 years in areas such as project, quality, and risk management, as well as in developing...
