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GlobePharma

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Melissa Herko, VP Sales & Marketing 11.28.23

Cleaning Validation | Validation

Compliance Insight

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Cindy Ipach, President 11.28.18

Limiting APIs in Manufacturing Effluent

An approach for setting limits on pharmaceuticals discharged in manufacturing effluent

Joan Tell, Robert Drinane, Bruce Naumann, Jessica Vestel, and Gregory Gagliano, Merck & Co., Inc. 06.02.16

Setting Health-Based Exposure Limits to Support Pharmaceutical Development and Manufacturing

Health-based exposure limits are needed to support risk assessments

B.D. Naumann, P.J. Nigro, U. Bruen, L. Parola, D. Cragin and A. Schatz, Merck & Co., Inc. and Ashland, Inc. 05.05.16

Analytical Services | Breaking News | Cleaning Validation | Industry News | Validation

Velesco Pharma Expands

Opens new cGMP-compliant analytical testing laboratory

02.09.16

Capsules | Cleaning Validation | Excipients | Validation

Who Knew?

The Law of Unintended Consequences

Emil W. Ciurczak, DoraMaxx Consulting 10.07.15

Deriving Health-Based Exposure Limits in the Pharmaceutical Industry

A workshop was convened to advance harmonization and best practices in ADE/PDE derivation and application

09.11.15

Cleaning Validation | Validation

Keeping Analytical Labs Modern

The chicken or the egg?

Emil W. Ciurczak, DoraMaxx Consulting 04.01.15

Sometimes, Even a Good Workman Can Blame His Tools

A new generation of equipment will help generate products with less cost and effort, while being made more efficiently.

Emil W. Ciurczak, DoraMaxx Consulting 01.29.15

Breaking News | Cleaning Validation | Industry News | Process Validation | Validation

AdvantaPure’s AdvantaPass Assigned Patent

System ensures room isolation during fluid transfer

11.18.14

Next-Gen ADCs: Collaborating to Improve Supply Chains for Development and Technology

A look into today’s ADC landscape and how collaboration aims to address ADC customer challenges.

Dr. Cynthia Wooge and Dr. Jyothi Swamy , SAFC 11.13.14

The New EU GMPs for Cross Contamination

Industry needs to prepare in order to comply with the updates.

Stephanie Wilkins , PharmaConsult US, Inc. 11.13.14

Contract Pharma’s 15th Anniversary Retrospective: Then & Now

A look back at the pharma/biopharma industry and outsourcing.

Kristin Brooks, Contract Pharma 10.14.14

Be Proactive About Disinfection Qualification

Unfortunately, most manufacturers wait until after a 483 or performance problem to revisit qualification practices. Proactive testing and continued monitoring ensure patient safety and compliance

Dave Rottjakob, Deborah Ensign, Shawn Sherry, and Kate Bloomrose 09.08.14

Cleaning Validation | Excipients | Supply Chain | Validation

How PAT Can Increase Your Profits

This is the first part in a series of articles discussing how process analytical technology (PAT) can add to your bottom line and suggesting baby steps you can take to using it.

Emil W. Ciurczak, DoraMaxx Consulting 09.08.14