Read, Learn, Innovate: Pharmaceutical Engineering® Summer Reading Part 2
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are suggested summer reading ideas—articles on important topics from recent issues to revisit when you have some down time this summer—or to enjoy for the first time in case you missed them. Learn more about knowledge management implementation, zero carbon, MES, and more.
Data Integrity in the Trenches: A Look into Quality Control Lab
The increasing importance of data integrity for companies throughout the global GMP-regulated industry is especially true during health authority inspections. Pharmaceuticals, biotech, and API manufacturers—as well as contract manufacturing organizations (CMOs) and contract laboratories—have been “in the trenches,” addressing improvements to strengthen data integrity and data management over the data life cycle.
Technology Trends: The Transition to Digitalization
In the pharmaceutical industry, digitalization involves developing and implementing digital technologies at all levels of pharmaceutical operations. The aim is to transform the industry by capturing, analyzing, and using vast amounts of data collected from a wide range of sources to support research and development, clinical development, drug manufacturing, supply chain management, patient engagement, quality assurance and quality control, product safety monitoring, and other objectives.
Bowtie Analysis and Barrier-Based Risk Management
Every business has legal, economical, and ethical objectives that range from mandatory safety to commercial goals to corporate citizenship. Businesses undertake a certain amount of risk to achieve these objectives. The balance between risk and reward is an ongoing challenge regardless of the activities involved. The bowtie technique can be used to visualize, assess, and manage risk.
Interpretation of Variance Components for Blend and Content Uniformity
Despite introducing modern analytical technology to assess blend uniformity, many companies are still using traditional blend sampling thieves and wet chemistry to assess blend homogeneity. The use of statistically based sampling plans allows variance component analysis to be conducted on both blend and dosage unit data. This article shows how various combinations of blend and dosage unit variance components (“within-location” and “between-location”) can be interpreted to identify potential root causes for homogeneity issues, including sampling bias, and how they can be mitigated.
Women in Pharma®: Empowering Women as Industry Leaders
Women in Pharma® is a place where women and men—especially those new to the industry—can access a network of mentors, role models, and educational resources to support their professional success. The widespread global interest and participation in this initiative and its events have shown that women in the pharmaceutical industry are hungry for the connection, mentoring, and education that Women in Pharma offers.
Read, Learn, Innovate: Pharmaceutical Engineering® Summer Reading Part 1
Enjoy more Pharmaceutical Engineering® Online suggested summer reading ideas.
