Featured in this edition of ISpeak Reading Roundup, are the top blog posts from August 2019. Discover key insights for data integrity, manufacturing excellence, innovative validation practices, and more for what the pharmaceutical industry was reading last month.
Industry tools for risk management and data-based decision making have become more progressive with the use of visual process mapping and multidimensional datasets. Learn more about how to leverage these tools in the presentation of quality data for pharmaceutical and medical devices in today’s facilities.
Hear from Charlie C. Wakeham on professionally reviewed instruction featured in the ISPE GAMP® Data Integrity for Manufacturing Records guide. The guide focuses on data Integrity and the importance of critical thinking for protection of laboratory data and records at every stage of the product lifecycle.
See the industry excel with Moderna, Inc. and their application of modern technologies, innovative solutions, and progressive facility concepts. Their new facility in Norwood, MA will help eliminate supply chain risks and solidify their commitment to patients in providing life-saving medicines.
Risk for contamination and regulatory violations decrease with an analysis of common mistakes and redesigned maintenance procedures. Read about the necessary planning, pre-requisites, and challenges that interfere with approved cleaning validation practices.
Explore a plan for continued process verification and the crucial parameters and attributes necessary for successful GMP bioprocess. This plan at its core evaluates close attention to statistical accuracy and managing process vulnerabilities.
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...