PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Exclusively for subscribers of Pharmaceutical Online, our content collections bundle articles centered around a particular topic or theme. These carefully curated selections feature content from both our internal team of editors as well as our subject matter experts who contribute regularly to the site.
Best Practices Working With CDMOs
In pharmaceuticals, working effectively with contract development and manufacturing organizations (CDMOs) is an art as well as a science. This e-book gives advice to established as well as emerging pharma companies on working with your CDMO on topics such as CMC support, quality assurance, risk assessment, and shared qualification audits, and it also provides tips to facilitate trust and to further the relationship.
Cleaning & Sterilization In Pharmaceutical Manufacturing
Sterility assurance, cleaning validation, and environmental monitoring continue to be hot subjects during pharmaceutical regulatory inspections and aseptic processing industry discussions. This e-book provides best practices of all aspects of this field.
Best Practices To Ensure Data Integrity In Your Pharma Supply Chain
As the pharmaceutical world is becoming more data-driven, you’ll need to pay closer attention to how your pharmaceutical company’s culture and operations ensure the completeness, consistency, and accuracy of data. Data specialists call this _data integrity_. Such data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA), according to the FDA. Similarly, data must be complete, consistent, and accurate throughout the data life cycle, according to the Medicines and Healthcare products Regulatory Agency (MHRA) and the Pharmaceutical Inspection Co-operation Scheme.
Pharmaceutical Regulatory Inspection/Enforcement Trends
Since the COVID-19 pandemic began, we’ve seen disruptions to regulatory inspection and enforcement. What has this looked like, and what has been the impact to the pharmaceutical industry? In this e-book, we dive in specifically to the regulatory agencies of the FDA in the U.S. and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
Moving Beyond Human Error In Biopharma Operations
In this roundtable Q&A, industry experts from AstraZeneca, Takeda, Biogen, and NSF Health Sciences share insights on important topics related to human performance in pharmaceutical operations. They discuss key drivers for human performance improvement, compare lean manufacturing and human performance programs, and provide perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines.
Risk Based Approaches To Establishing Sample Sizes For Process Validation
This ebook is a compilation of various statistically based techniques to help determine risk-based sample sizes to support process validation activities. Process validation is one of the most commonly cited 483 Inspectional Observations issued by the FDA. The citations often reveal the organization failed to “ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure” (21 CFR 820.75 – Process validation).
Identifying And Resolving Errors, Defects, And Problems Within Your Organization
This guide is a critical look at the best and most fundamental methods I have employed over many years to help innumerable companies prosper. From it, take what you need in order to assist those with whom you work. The net result of this information sharing is that the future of healthcare, in all of its forms, gets better for humanity. We can all only benefit from better approaches to our work and smarter problem-solving, and I'm honored to be your guide here.
Drug Delivery Insights For The Pharmaceutical Industry
Whether you’re trying to coax a toddler into taking cough medicine or puzzling out how best to introduce a large-molecule biologic, each drug delivery scenario presents unique challenges. Teams developing the drug must work hand-in-hand with teams developing the delivery device, ultimately agreeing on the proper combination of elements to best serve the intended patient pool — a process that weaves together decisions concerning biocompatibility, container size and shape, delivery mechanism, human factors engineering, and countless other elements. In this eBook, our editors have assembled insights from some of the experts in this field among our editorial contributors.
Data Integrity In The Life Sciences
This free collection of articles is from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.
Rethinking Bioprocess Facility Design
Frequent expert guests Herman and Erich Bozenhardt bring a collective 54 years of bioprocess facility design and production experience to the pages of this comprehensive ebook. In this compilation of their work, the father-and-son duo cover basic and advanced biopharma production considerations—from controlling bioburden to the unique challenges associated with filling autologous therapies—in the authoritative and snappy style that's become their trademark. Download this wide-ranging resource and learn how to let go of legacy aseptic filling line equipment, seven common filling blunders and how to avoid them, nontraditional design concepts for CAR T processing, what to do when your isolator is taking too long to de-gas, and a whole lot more.
Quality Risk Management 101
Free collection of articles exploring topics including the various types of risks associated with medicinal products, the role of risk management in pharmaceutical and biopharmaceutical regulation, QRM principles and practices, the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.
Cleaning Validation For The 21st Century
A collection of articles on the application of Science, Risk and Statistics to Cleaning.