Compliance eHandbooks

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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

Mining pharma's reshoring rush

It’s time for the U.S. to sift through domestic drug manufacturing efforts

Editors' (re)View: More lawsuits for J&J; Abortion pills as controlled substances

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of May 20

Selecting a cell culture media manufacturer: considerations to reduce risks

This article shares five top considerations when selecting a cell culture media supplier for a catalog medium or custom formulation manufacturing. Learn ways to maximize confidence...

The key to ending drug shortages: data transparency

By connecting quality, regulatory and manufacturing data, companies can bring agility across the supply chain

Editors' (re)View: Hot flash treatment space heats up; Alzheimer's resilience

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of May 13

The untapped potential of drug capsules

What groundbreaking innovations lie ahead for capsules and how will these developments redefine their role in drug delivery?

Converting viral vector facilities to mRNA  

With the right considerations, pharma can pivot its plants to meet market needs

Editors' (re)View: AML trial challenges; FTC digs into Novo-Catalent deal

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of May 5

Mitigating bioaerosol risks in pharma plants

Amid limited guidance from regulators, facility designers can deliver significant safety advantages by tackling risks at the source

Editors' (re)View: The fate of Emergent's plants; ADC win for Pfizer, Genmab

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of April 29

Sharpening pharma's data integrity with automation

Built-in ability to meet data integrity standards should be a central focus when selecting control systems and manufacturing execution systems for pharma manufacturing

Breaking through pharma's digital innovation barrier

Digital maturity in pharmaceutical supply chains must rapidly scale to meet demand

Editors' (re)View: McKinsey under fire for opioid crisis; Nexus gives up its generic plant

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

Navigating pharma’s leap into the predictive plant era

Real-time predictive analysis is the key to digital plant maturity

eBook: Quality & compliance

Upholding rigorous quality standards is not only a regulatory imperative but also vital for ensuring the efficacy and safety of pharmaceutical products. And as many pharma manufacturers...

Energy as a Service: Fortune 500 Insights on Risk Transfer and Sustainability

Nine out of 10 Fortune 500 executives surveyed expressed interest in the idea of outsourcing energy operations to reduce risk. Learn how an Energy as a Service model can support...