Compliance eHandbooks

Other eHandbooks

Editors' (re)View: FDA’s rare disease push; Strides in Batten disease treatment

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 21

Melting schizophrenia treatment barriers

Drugmakers are developing drugs that target different neurotransmitter systems, providing effective, long-acting treatments with fewer side effects and improved adherence

What USP <665> means for the future of pharma manufacturing

New guidelines set to become mandatory in 2026 are driving significant changes in the regulation of single-use systems

Editors' (re)View: Greetings from Portugal; The future of weight loss drugs

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 14

Editors' (re)View: FDA second chances; FTC takes aim at PBMs

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 8

Optimizing Pneumatic Performance in Biomanufacturing

Discover how simplifying pneumatic circuits enhances drug production efficiency, quality, and control in the growing life sciences market.

How sustainable practices in pharma drive long-term growth

Sustainability is not merely an environmental concern but a strategic imperative that can enhance revenues, reduce costs and foster innovation

Editors' (re)View: BARDA bucks for MCM; Landmark Alzheimer’s approval

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 1

Revolutionizing pharmaceutical cold storage

In pharma, cold storage has historically been labor-intensive and highly regulated, but new automated technology is helping the industry meet demands

Key considerations for designing an efficient material transfer station suite

Containment, HVAC, control and electrical requirements are crucial for designing a CGMP-compliant material transfer station

Editors' (re)View: The fate of interchangeability studies; CDMOs and CRLs

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of June 22

Pharma’s steadfast cure to production woes

Dependable, automated communication is the key to a more effective and productive work environment

Challenges to data integrity in the pharma lab

To prioritize data integrity in the lab, companies must implement good data practices throughout the R&D process

eBook: Packaging Trends

In the modern pharma landscape, packaging is more than just a protective barrier for drug products. Effective packaging ensures drug quality, complies with traceability regulations...

Editors' (re)View: Intra-Cellular depression drug nears regulatory submission; Eli Lilly targets counterfeiters

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of June 17

Ensuring CAPA lives up to its name

How pharma can use CAPA as a tool to support continuous process improvement

Hurricane season is approaching, time for pharma manufacturers to buckle down 

Different disruptions call for different protocols and methods, and now is the time to prepare

Editors' (re)View: AdComm nod for Lilly Alzheimer's drug; SCOTUS mifepristone decision

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of June 10

Pharma manufacturing in the (virtual) clouds

Digital twins are a valuable tool for bringing the pharma industry into the future

Efficient-Pro Medium and Feeds enhance productivity and quality in CHO-K1 and CHO-S

Enhance your bioproduction with Gibco™ Efficient-Pro™ Medium and Feed systems, achieving increased productivity in CHO-K1 and CHO-S cells. Experience reduced variability and superior...

Efficient-Pro Medium and Feeds improve productivity in CHO-K1, CHO-S, and DG44 cells

Elevate your CHO cell culture productivity with the Gibco™ Efficient-Pro™ Medium and Feed System. Download our application note to explore how the Efficient-Pro™ Medium and Feeds...

Gibco Efficient-Pro Medium and Feeds Evaluation Guide

Ready to Transform Your mAb Manufacturing Workflow? Enhance productivity and efficiency with our advanced Efficient-Pro™ media and feed systems​

Compliance fire drill: Mock FDA audits for cleaning validation

Pharma manufacturers should incorporate worst-case scenarios into assessment processes

Keeping pace with pharma packaging

Pharma manufacturers need modern printing, marking and coding solutions to ensure compliance and stay ahead of trends

Harnessing the power of bispecific antibodies

With increased pharma partnerships, FDA approvals and positive market trends, bispecific antibodies are here to stay

Editors' (re)View: Warp speed: The next generation; FDA Adcomm votes against MDMA for PTSD 

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of June 3

Warp speed: The next generation in pharma

Six pharma companies have revealed that they were chosen to participate in the FDA's rare disease pilot program

Removing reshoring's gold-colored glasses

What will it take to make domestic drug production more than a glint in the pan?

Building the next generation of future-ready pharma labs

To achieve lab transformation, leaders must confront challenges in data, technology, people and processes

Automated calibration processes improve efficiency and compliance in the pharmaceutical industry

Major players in the pharmaceutical industry are embracing digitalization – calibration processes, however, are still largely paper-based. This results in operational inefficiencies...

Pushing the boundaries of health with pharma tech advancements

From drug containment solutions to modern manufacturing technologies, the latest advancements are setting new standards for what’s possible in health care

Virginia is for pharma lovers

Richmond has rebounded from its tobacco breakup and is courting a serious relationship with advanced manufacturing technology

Editors' (re)View: Pandemic disagreements; GDUFA research recap

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of May 27

Preventive maintenance schedule

Get your free maintenance guide to help prevent pests in your facility.

Shoring up pharma supply chains

Aging populations are straining pharma production — here’s what the industry should do

U.S. legislation and directives for domestic drug manufacturing

The U.S. movement to repatriate generic drugs, APIs and ingredients has triggered a rush of legislation

Mining the reshoring rush: Targeting government spending

In part one of our series, we discuss efforts to establish a comprehensive reshoring list

Mining the reshoring rush: Sustaining efforts once infrastructure investments dry up

In part two of our series, we explore what it will take for domestic companies to be self-sustaining and the role of advanced technologies