Newsletter | June 11, 2019

06.11.19 -- Keys To Better Microbial Data Deviation Investigations

  Formulation Of Pharmaceutical Suspensions: 4 Critical Considerations For Success

Pharmaceutical suspensions are an effective dosage form for the delivery of therapeutic agents. Suspensions can improve the chemical stability of a drug, control the rate of drug absorption, and exhibit higher bioavailability than other dosage forms. Suspensions are effective to mask the bitter or unpleasant taste of oral dosage. 


This article discusses four critical areas for attention to ensure the stability of the final dosage form. Learn more.

Featured Editorial
Essential Points To Consider For Better Microbial Data Deviation Investigations
By Paula Peacos, ValSource, Inc.

Microbial data deviation investigations are notoriously difficult to perform. They are time consuming and labor intensive. Determining the definitive root cause is often challenging. Evidence to support conclusions and decisions takes time to collect, and the available evidence is usually circumstantial and often scanty.

“Work Harder” — And Other Ways To Completely Miss The Mark On Quality
By Ben Locwin, Ph.D.

Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone seems to go along with the rhetoric.

Industry Insights
The Importance Of Data Analysis In Solid-State Characterization
White Paper | By Bhupatsinh Vihol, Piramal Pharma Solutions

The secret to performing a thorough solid-state characterization involves integrating all data that may be generated across various instruments at different laboratories and properly interpreting that data.

Guidelines For Selecting A Medical Device Contract Manufacturer
Article | By Keith Calvert, West Pharmaceutical Services, Inc.

Consider these guidelines when evaluating potential device contract manufacturers to choose one that will be the best fit for your company.

Reducing Risks In Tablet Presses And Tooling With Effective Cleaning
Article | By Danna Schwerdt, Natoli Engineering Company, Inc.

With properly cleaned and maintained tooling, tablet manufacturers can expect the highest quality of tablets and a longer production life from their tooling. 

USP <1207> Updates Leak Testing Recommendations For Pharma Companies
Article | By Hemi Sagi, Advanced Test Concepts (ATC) by Pfeiffer Vacuum

Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and, in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.

Applying Quality Systems Approach To Improve Supply Chain Management
Article | B. Braun OEM Division

This article presents a quality systems technique that is ideal for improving trust between a manufacturer and a supplier, as well as improving the overall quality of medical devices.

Beyond Procurement: A Strategic Approach To Comparator Drug Sourcing
White Paper | Thermo Fisher Scientific

The escalating volume and complexity of global clinical trials have been accompanied by a corresponding increase in the demand for comparator drugs.

Use Of Sodium Hydroxide For Cleaning And Sanitization Of Chromatography Resins And Systems
Application Note | GE Healthcare Life Sciences

This application note examines these aspects of using sodium hydroxide as a cleaning and sanitizing agent.

Rapid Large-Scale Mixing Of Clumped Powder In Pharma Manufacturing
Application Note | ILC Dover

For operations where low shear and high product integrity are required, traditional technologies pose a risk to the quality of the final product.

Multi-Agitator High-Shear Mixing System Assists In CMC Dispersions
Case Study | Charles Ross and Son Company

Conventional agitators are unable to create the fluid circulation necessary to properly disperse 4 percent + powdered CMC dispersions. The consequence of insufficient agitation is the formation of non-dispersed lumps.

Pharma Company Benefits From Strategic CMC Outsourcing Partnership
Case Study | Almac Group

After successfully outsourcing an initial chemistry, manufacturing, and controls (CMC) project, a global Big Pharma company sought a more strategic CMC outsourcing partnership.

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