Compliance eHandbooks

Other eHandbooks

ebook: Automation & Smart Pharma 2024

In this eBook, you will gain insights on: Sharpening pharma's data integrity with automation The top 10 most digitally innovative pharma companies Building the next generation...

The Strategic Advantages of X-ray Fluorescence for Pharmaceutical Elemental Analysis

X-Ray Fluorescence (XRF) technology streamlines elemental impurity screening, offering faster, cost-effective, and resource-efficient alternatives to traditional ICP methods in...

Real-time compliance in pharmaceutical waters

Proper and thorough monitoring of pharmaceutical water systems is imperative to prevent undetected issues from shutting down production and to deliver the highest quality products...

4 key compendial measurements for pharma water compliance

A fundamental aspect of pharmaceuticals manufacturing is the production of purified waters that meet pharmacopeia regulations. For continuous assurance of water quality, on-line...

Flow imaging microscopy: Transforming biopharmaceutical particle analysis

Discover the power of Flow Imaging Microscopy in biopharmaceuticals. Learn how FIM works and how it can uncover details in your samples, enhancing the characterization of API ...

eBook: Supply chain trends

Supply chain challenges have long been a reality for pharma manufacturers, but the pandemic underscored the critical need for enhanced visibility and control. Added pressures,...

eBook: Reshoring manufacturing: Progress and challenges

A collective analysis of reshoring efforts across several major manufacturing industries

Optimizing Pneumatic Performance in Biomanufacturing

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

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...

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​

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...

Preventive maintenance schedule

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

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...

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...

Navigating data integrity compliance

Discover insights into FDA's Data Integrity Guidance and how to leverage the Cloud to achieve GMP compliance.

A Paperless Future: How Blue Mountain Revolutionized Asset Management at AmplifyBio

Discover how Blue Mountain's Regulatory Asset Manager (RAM) propelled AmplifyBio, a leading Contract Research Organization (CRO), into a paperless future.

Harnessing the Power of Industry 4.0 for Life Science

Leverage the latest advancements in technologies to drive innovation and deliver improved patient outcomes.

Innovate with confidence: Smoothing the path to successful mRNA manufacturing

mRNA-LNP manufacturing is fraught with obstacles, resulting in higher program risk, inflated costs, and delayed market release. With the right knowledge, companies can overcome...

5 ways dust collectors help ensure a controlled environment when tableting APIs

During tableting processes, APIs become airborne. These dust particles can harm workers, reduce air quality, contaminate products and cause explosions. Learn how dust collectors...

White paper: Stop sweating temperature excursions

Advanced chemical indicators give you the peace of mind that comes from reliable insights into your supply chains.

White paper: A path to 24/7 success for your company

Learn how digitalization can drive 24/7 success in your facility with our newest white paper.

White paper: System integration in liquid handling

Considerations for obtaining optimal results in laboratory and medical devices

White paper: Adopting novel technologies to improve mAb processes

Are purification strategies for mAbs moving you forward, or holding you back?

White paper: Advantages of dry vacuum technology for pharma processes

Vacuum technology plays a crucial role in pharmaceutical processes (conveying, inertization, distilling, and drying). Using the most efficient vacuum technology can make these...

Case study: Manufacturing dry powder media from development to large-scale cGMP production

Learn the process and results of a two-phase scale-up strategy that was used for three complex dry powder medium products.

White paper: Revolutionizing microbial bioproduction with chemically defined fermentation media

Learn more about how the innovation of chemically defined microbial media has created a new paradigm of microbial bioprocessing, one which has the potential to enhance the performance...

Case study: Maintaining quality and equivalency in custom cell culture media manufacturing from development to large-scale cGMP production

Challenges can arise when transitioning a media formulation from a non-cGMP prototype to a cGMP-manufactured product. Our case study outlines the scale-up process that was used...

Smoothing the transition: liquid, dry powdered media, and advanced granular technologies

Considering scalability, cost effectiveness, and convenience is essential to find a media format that can meet your current and future needs. Read our article to learn more about...

Five factors to consider when scaling up biologics production to meet global commercial output

Scale-up is a critical stage, with an optimized medium and robust supply chains being central to consistent product quality and a cost-effective process. Read our article to discover...

Aggregation Solution for Contract Manufacturing Organization

A Contract Manufacturing Organization that produces and packages pharmaceuticals for customers which are then distributed in more than 150 countries found a solution to supply...

eBook: Best of Pharma 2023

A collection of the most-read feature articles of the year, chosen by the Pharma Manufacturing digital audience.

eBook: Biopharma trends 2023

The U.S. is the largest pharmaceutical market by value and its drug spending has continued to outgrow the global market — and this is largely driven by biologics, which have seen...

Special report: OT cybersecurity incident response — Are you ready?

Operational technology (OT) risks are on the rise, with more threat actors and incidents targeting manufacturers by the day. Even when organizations invest in preventative OT ...