Quality & Risk eHandbooks

How to Guide: Building a business case for a digitalized QC platform

Discover five steps required to help create a compelling business case and get the key facts and figures you need to achieve senior buy-in for a digitalized QC Platform.

Why should CDMOs adhere to the new CDER's Rating System?

Dive into excellence: Discover how FDA's QMM program & CDER's rating system empower CDMOs to ensure top-quality pharmaceuticals, prevent shortages & build reliability. Uncover...

Guide: Hygienic design considerations for weighing equipment

Contamination can lead to costly recalls, a damaged reputation, and ultimately harm to customers. Learn how to check your weighing equipment for key hygienic features and find...

Application note: Monitoring pharma solvent drying processes

What if you could achieve faster off-gas composition analysis without sacrificing precision and quality? Learn how to gain improved precision, accuracy, long intervals between...

eBook: Quality 2022

In the pharma industry, quality is an area where this is no room for compromise. As such, manufacturers' pursuit of quality enhancements is ongoing.

Research report: The true value of real-time microbial monitoring

With many pharma manufacturers operating sophisticated (and costly) continuous water purification systems, results that come days after a sample has been taken do little to ensue...

Special Report: Efficiency gains for pharmaceutical QC

When it comes to pharmaceutical water, anything less than perfection is a risk.

eBook: Quality 2021

In pharma, quality is a high-stakes business — not only measured in dollars, but more importantly, impacting patient lives.

Research Report: Exploring Pharma's CAPA Challenges

Bringing the Pharma industry closer to it's CAPA goals requires a systematic approach. This special report presents the results and analysis of a recent industry survey indicating...

Proof Testing Level Instruments

An important part of validating the safety function in a level instrument is the requirement for regular proof testing. However, full testing can lead to increased risk and process...

Presentation: Applying Six Sigma to QbD

Dr. Hussain's recent presentation at the 28th Annual Midwest Biopharmaceutical Statistical Workshop at Ball State University provides a detailed overview of how Six Sigma principles...

FDA Guidance: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

This document provides guidance to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment, specifically on (1) safety signal identification, (2) pharmacoepide...

Other eHandbooks

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...

Editors' (re)View: A new obesity startup; Schizophrenia treatment happenings

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of April 15.

Pharma's molecular glue garden

With key players entering the ring and many clinical trials underway, the molecular glue garden is bound to bloom soon

Editors' (re)View: Advancing mental health treatment; CMS proposes financial incentives for gene therapy access

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

Batch process understanding for process validation and quality control

A first-of-its-kind study of isotopic values of paired reactants and products offers a prospective new method of process understanding

The pharma manufacturing facility of the future

The challenges are surmountable — and worth taking on to help build advantages

The state of pharma manufacturing

A recent industry revenue report found that effective data use is key in pharma, yet underexploited

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...

Strengthening pharma’s sustainability foundation

New tools can help seamlessly integrate sustainability into R&D and production goals

Editors' (re)View: ALS and drug approval criteria; Verve trial paused again

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

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...

Five challenges pharma manufacturers face in 2024

The industry must understand and mitigate the impact of short- and long-term obstacles

Vaccines of the future

There is a new era of vaccinology in pharma's pipelines

Editors' (re)View: J&J can contest talc scientific evidence; SCOTUS mifepristone hearing met with skepticism

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of March 25

Exploring alternative distribution models for pharma supply chains

ADMs allow manufacturers to take charge of supply channels to boost efficiency and flexibility

Editors' (re)View: J&J cast-off anti-hypertensive wins approval; Orchard prices MLD therapy at $4.25M

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of March 18

White paper: Stop sweating temperature excursions

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

Editors' (re)View: FDA shares early AD industry guidance; WuXi-BIO breakup

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of March 11

Anticipating AI regulations in pharma manufacturing

In a rapidly evolving regulatory landscape, leaders should remain ready to adapt to new legislation

Leveraging lean innovation principles

How pharma can apply tactics from other industries to tackle recent policy cost initiatives

Charting a sustainable path for generics

Key takeaways from the Association for Accessible Medicines’ Access! 2024 meeting

Editors' (re)View: Perrigo launches OTC birth control; Lilly takes aim at celebs

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of March 4

Breaking down pharma compliance barriers

How pharma companies are solving regulatory challenges with AI-based technology

Navigating the smaller batch market

Pharma innovators are using technology to meet the unique demands of today’s small scale era

FDA decisions to watch in 2024   

This year, the agency will decide on groundbreaking treatments for conditions like Alzheimer's, NASH, pulmonary hypertension and more

5 Pharma changemakers

The CNBC 2024 Changemakers list highlighted fifty women as transformative leaders, including five from the pharma industry

Editors' (re)View: Probing pharma-sponsored testing; FDA approves Alvotech-Teva Humira biosim 

Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of February 24

Pharma CDMOs with sky-high ambitions

A snapshot of the bold CDMOs working to build pharma’s modern treatments

The role of workwear in mitigating pharma workplace hazards

Ergonomic clothing explicitly designed for the industry helps avoid common safety incidents, as well as aid in compliance